--- kind: "range" citation: "21 U.S.C. §§ 801–966" title: "21" from: "801" to: "966" count: 101 release: "119-102" url: "https://uscodex.org/usc/21/801..966" --- # §801. Congressional findings and declarations: controlled substances The Congress makes the following findings and declarations: - (1) Many of the [drugs](/usc/21/321.md?p=g-1) included within this subchapter have a useful and legitimate medical purpose and are necessary to maintain the health and general welfare of the American people. - (2) The illegal importation, [manufacture](/usc/21/802.md?p=15), [distribution](/usc/21/360eee.md?p=5), and possession and improper use of [controlled substances](/usc/21/802.md?p=6) have a substantial and detrimental effect on the health and general welfare of the American people. - (3) A major portion of the traffic in [controlled substances](/usc/21/802.md?p=6) flows through interstate and foreign commerce. Incidents of the traffic which are not an integral part of the interstate or foreign flow, such as [manufacture](/usc/21/802.md?p=15), local [distribution](/usc/21/360eee.md?p=5), and possession, nonetheless have a substantial and direct effect upon interstate commerce because— - (A) after [manufacture](/usc/21/802.md?p=15), many [controlled substances](/usc/21/802.md?p=6) are transported in interstate commerce, - (B) [controlled substances](/usc/21/802.md?p=6) distributed locally usually have been transported in interstate commerce immediately before their [distribution](/usc/21/360eee.md?p=5), and - (C) [controlled substances](/usc/21/802.md?p=6) possessed commonly flow through interstate commerce immediately prior to such possession. - (4) Local [distribution](/usc/21/360eee.md?p=5) and possession of [controlled substances](/usc/21/802.md?p=6) contribute to swelling the interstate traffic in such substances. - (5) [Controlled substances](/usc/21/802.md?p=6) manufactured and distributed intrastate cannot be differentiated from [controlled substances](/usc/21/802.md?p=6) manufactured and distributed interstate. Thus, it is not feasible to distinguish, in terms of [controls](/usc/21/802.md?p=5), between [controlled substances](/usc/21/802.md?p=6) manufactured and distributed interstate and [controlled substances](/usc/21/802.md?p=6) manufactured and distributed intrastate. - (6) Federal [control](/usc/21/802.md?p=5) of the intrastate incidents of the traffic in [controlled substances](/usc/21/802.md?p=6) is essential to the effective [control](/usc/21/802.md?p=5) of the interstate incidents of such traffic. - (7) The [United States](/usc/21/802.md?p=28) is a party to the [Single Convention on Narcotic Drugs](/usc/21/802.md?p=31), 1961, and other international conventions designed to establish effective [control](/usc/21/802.md?p=5) over international and domestic traffic in [controlled substances](/usc/21/802.md?p=6). # §801a. Congressional findings and declarations: psychotropic substances The Congress makes the following findings and declarations: - (1) The Congress has long recognized the danger involved in the [manufacture](/usc/21/802.md?p=15), [distribution](/usc/21/360eee.md?p=5), and use of certain psychotropic substances for nonscientific and nonmedical purposes, and has provided strong and effective legislation to [control](/usc/21/802.md?p=5) illicit [trafficking](/usc/21/2341.md?p=4) and to regulate legitimate uses of psychotropic substances in this country. Abuse of psychotropic substances has become a phenomenon common to many countries, however, and is not confined to national borders. It is, therefore, essential that the [United States](/usc/21/802.md?p=28) cooperate with other nations in establishing effective [controls](/usc/21/802.md?p=5) over international traffic in such substances. - (2) The [United States](/usc/21/802.md?p=28) has joined with other countries in executing an international treaty, entitled the Convention on Psycho­tropic Substances and signed at Vienna, Austria, on February 21, 1971, which is designed to establish suitable [controls](/usc/21/802.md?p=5) over the [manufacture](/usc/21/802.md?p=15), [distribution](/usc/21/360eee.md?p=5), transfer, and use of certain psychotropic substances. The Convention is not self-executing, and the obligations of the [United States](/usc/21/802.md?p=28) thereunder may only be performed pursuant to appropriate legislation. It is the intent of the Congress that the amendments made by this Act, together with existing law, will enable the [United States](/usc/21/802.md?p=28) to meet all of its obligations under the Convention and that no further legislation will be necessary for that purpose. - (3) In implementing the [Convention on Psychotropic Substances](/usc/21/802.md?p=31), the Congress intends that, consistent with the obligations of the [United States](/usc/21/802.md?p=28) under the Convention, [control](/usc/21/802.md?p=5) of psychotropic substances in the [United States](/usc/21/802.md?p=28) should be accomplished within the framework of the procedures and criteria for classification of substances provided in the Comprehensive [Drug](/usc/21/321.md?p=g-1) Abuse Prevention and Control Act of 1970 [[21 U.S.C. 801](/usc/21/801.md) et seq.]. This will insure that (A) the availability of psychotropic substances to [manufacturers](/usc/21/802.md?p=15), [distributors](/usc/21/802.md?p=11), [dispensers](/usc/21/802.md?p=10), and researchers for useful and legitimate medical and scientific purposes will not be unduly restricted; (B) nothing in the Convention will interfere with bona fide research activities; and (C) nothing in the Convention will interfere with ethical medical practice in this country as determined by the [Secretary](/usc/21/802.md?p=24) of Health and Human Services on the basis of a consensus of the views of the American medical and scientific community. # §802. Definitions As used in this subchapter: - (1) The term “addict” means any individual who habitually uses any [narcotic drug](#17) so as to endanger the public morals, health, safety, or welfare, or who is so far addicted to the use of [narcotic drugs](#17) as to have lost the power of self-[control](#5) with reference to his addiction. - (2) The term “administer” refers to the direct application of a [controlled substance](#6) to the body of a patient or research subject by— - (A) a [practitioner](#21) (or, in his presence, by his [authorized](/usc/21/360eee–1.md?p=a-6) [agent](#3)), or - (B) the patient or research subject at the direction and in the presence of the [practitioner](#21), whether such application be by injection, inhalation, ingestion, or any other means. - (3) The term “agent” means an [authorized](/usc/21/360eee–1.md?p=a-6) [person](/usc/21/379j–21.md?p=k-10) who acts on behalf of or at the direction of a [manufacturer](#15), [distributor](#11), or [dispenser](#10); except that such term does not include a common or contract carrier, public warehouseman, or employee of the carrier or warehouseman, when acting in the usual and lawful course of the carrier’s or warehouseman’s business. - (4) The term “Drug Enforcement Administration” means the Drug Enforcement Administration in the Department of Justice. - (5) The term “control” means to add a [drug](/usc/21/321.md?p=g-1) or other substance, or [immediate precursor](#23), to a schedule under part B of this subchapter, whether by transfer from another schedule or otherwise. - (6) The term “controlled substance” means a [drug](/usc/21/321.md?p=g-1) or other substance, or [immediate precursor](#23), included in schedule I, II, III, IV, or V of part B of this subchapter. The term does not include distilled spirits, wine, malt beverages, or tobacco, as those terms are defined or used in subtitle E of the Internal Revenue Code of 1986. - (7) The term “counterfeit substance” means a [controlled substance](#6) which, or the container or labeling of which, without authorization, bears the trademark, trade name, or other identifying mark, imprint, number, or [device](/usc/21/355–2.md?p=a-3), or any likeness thereof, of a [manufacturer](#15), [distributor](#11), or [dispenser](#10) other than the [person](/usc/21/379j–21.md?p=k-10) or [persons](/usc/21/379j–21.md?p=k-10) who in fact manufactured, distributed, or dispensed such substance and which thereby falsely purports or is represented to be the product of, or to have been distributed by, such other [manufacturer](#15), [distributor](#11), or [dispenser](#10). - (8) The terms “deliver” or “delivery” mean the actual, constructive, or attempted transfer of a [controlled substance](#6) or a [listed chemical](#33), whether or not there exists an agency relationship. - (9) The term “depressant or stimulant substance” means— - (A) a [drug](/usc/21/321.md?p=g-1) which contains any quantity of barbituric acid or any of the salts of barbituric acid; or - (B) a [drug](/usc/21/321.md?p=g-1) which contains any quantity of (i) amphetamine or any of its optical [isomers](#14); (ii) any salt of amphetamine or any salt of an optical [isomer](#14) of amphetamine; or (iii) any substance which the Attorney General, after investigation, has found to be, and by regulation designated as, habit forming because of its stimulant effect on the central nervous system; or - (C) lysergic acid diethylamide; or - (D) any [drug](/usc/21/321.md?p=g-1) which contains any quantity of a substance which the Attorney General, after investigation, has found to have, and by regulation designated as having, a potential for abuse because of its depressant or stimulant effect on the central nervous system or its hallucinogenic effect. - (10) The term “dispense” means to [deliver](#8) a [controlled substance](#6) to an [ultimate user](#27) or research subject by, or pursuant to the lawful order of, a [practitioner](#21), including the prescribing and administering of a [controlled substance](#6) and the packaging, labeling or compounding necessary to prepare the substance for such [delivery](#8). The term “dispenser” means a [practitioner](#21) who so [delivers](#8) a [controlled substance](#6) to an [ultimate user](#27) or research subject. - (11) The term “distribute” means to [deliver](#8) (other than by administering or dispensing) a [controlled substance](#6) or a [listed chemical](#33). The term “distributor” means a [person](/usc/21/379j–21.md?p=k-10) who so [delivers](#8) a [controlled substance](#6) or a [listed chemical](#33). - (12) The term “[drug](/usc/21/321.md?p=g-1)” has the meaning given that term by [section 321(g)(1) of this title](/usc/21/321.md?p=g-1). - (13) The term “felony” means any Federal or [State](#26) offense classified by applicable Federal or [State](#26) law as a felony. - (14) The term “isomer” means the optical isomer, except as used in schedule I(c) and schedule II(a)(4). As used in schedule I(c), the term “isomer” means any optical, positional, or geometric isomer. As used in schedule II(a)(4), the term “isomer” means any optical or geometric isomer. - (15) The term “manufacture” means the [production](#22), preparation, propagation, compounding, or processing of a [drug](/usc/21/321.md?p=g-1) or other substance, either directly or indirectly or by extraction from substances of natural origin, or independently by means of chemical synthesis or by a combination of extraction and chemical synthesis, and includes any packaging or repackaging of such substance or labeling or relabeling of its container; except that such term does not include the preparation, compounding, packaging, or labeling of a [drug](/usc/21/321.md?p=g-1) or other substance in conformity with applicable [State](#26) or local law by a [practitioner](#21) as an incident to his administration or dispensing of such [drug](/usc/21/321.md?p=g-1) or substance in the course of his professional practice. The term “manufacturer” means a [person](/usc/21/379j–21.md?p=k-10) who manufactures a [drug](/usc/21/321.md?p=g-1) or other substance. - (16) - (A) Subject to [subparagraph (B)](#16-B), the terms “marihuana” and “marijuana” mean all parts of the plant Cannabis sativa L., whether growing or not; the seeds thereof; the resin extracted from any part of such plant; and every compound, [manufacture](#15), salt, derivative, mixture, or preparation of such plant, its seeds or resin. - (B) The terms “[marihuana](#16-A)” and “[marijuana](#16-A)” do not include— - (i) hemp, as defined in [section 1639o](/usc/7/1639o.md) of title 7; or - (ii) the mature stalks of such plant, fiber produced from such stalks, oil or cake made from the seeds of such plant, any other compound, [manufacture](#15), salt, derivative, mixture, or preparation of such mature stalks (except the resin extracted therefrom), fiber, oil, or cake, or the sterilized seed of such plant which is incapable of germination. - (17) The term “narcotic drug” means any of the following whether produced directly or indirectly by extraction from substances of vegetable origin, or independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis: - (A) Opium, [opiates](#18), derivatives of opium and [opiates](#18), including their [isomers](#14), esters, ethers, salts, and salts of [isomers](#14), esters, and ethers, whenever the existence of such [isomers](#14), esters, ethers, and salts is possible within the specific chemical designation. Such term does not include the isoquinoline alkaloids of opium. - (B) [Poppy straw](#20) and concentrate of [poppy straw](#20). - (C) Coca leaves, except coca leaves and extracts of coca leaves from which cocaine, ecgonine, and derivatives of ecgonine or their salts have been removed. - (D) Cocaine, its salts, optical and geometric [isomers](#14), and salts of [isomers](#14). - (E) Ecgonine, its derivatives, their salts, [isomers](#14), and salts of [isomers](#14). - (F) Any compound, mixture, or preparation which contains any quantity of any of the substances referred to in [subparagraphs (A) through (E)](#17-A..17-E). - (18) The term “opiate” or “opioid” means any [drug](/usc/21/321.md?p=g-1) or other substance having an addiction-forming or addiction-sustaining liability similar to morphine or being capable of conversion into a [drug](/usc/21/321.md?p=g-1) having such addiction-forming or addiction-sustaining liability. - (19) The term “opium poppy” means the plant of the species Papaver somniferum L., except the seed thereof. - (20) The term “poppy straw” means all parts, except the seeds, of the [opium poppy](#19), after mowing. - (21) The term “practitioner” means a physician, dentist, veterinarian, scientific investigator, pharmacy, hospital, or other [person](/usc/21/379j–21.md?p=k-10) [licensed](/usc/21/360eee–1.md?p=a-6), registered, or otherwise permitted, by the [United States](#28) or the jurisdiction in which he practices or does research, to [distribute](#11), [dispense](#10), conduct research with respect to, [administer](#2), or use in teaching or chemical analysis, a [controlled substance](#6) in the course of professional practice or research. - (22) The term “production” includes the [manufacture](#15), planting, cultivation, growing, or harvesting of a [controlled substance](#6). - (23) The term “immediate precursor” means a substance— - (A) which the Attorney General has found to be and by regulation designated as being the principal compound used, or produced primarily for use, in the [manufacture](#15) of a [controlled substance](#6); - (B) which is an immediate chemical intermediary used or likely to be used in the [manufacture](#15) of such [controlled substance](#6); and - (C) the [control](#5) of which is necessary to prevent, curtail, or limit the [manufacture](#15) of such [controlled substance](#6). - (24) The term “Secretary”, unless the context otherwise indicates, means the Secretary of Health and Human Services. - (25) The term “serious bodily injury” means bodily injury which involves— - (A) a substantial risk of death; - (B) protracted and obvious disfigurement; or - (C) protracted loss or impairment of the function of a bodily member, organ, or mental faculty. - (26) The term “State” means a State of the [United States](#28), the District of Columbia, and any commonwealth, [territory](/usc/21/387.md?p=19), or possession of the [United States](#28). - (27) The term “ultimate user” means a [person](/usc/21/379j–21.md?p=k-10) who has lawfully obtained, and who possesses, a [controlled substance](#6) for his own use or for the use of a member of his household or for an animal owned by him or by a member of his household. - (28) The term “United States”, when used in a geographic sense, means all places and waters, continental or insular, subject to the jurisdiction of the United States. - (29) The term “maintenance treatment” means the dispensing, for a period in excess of twenty-one days, of a [narcotic drug](#17) in the treatment of an individual for dependence upon heroin or other morphine-like [drugs](/usc/21/321.md?p=g-1). - (30) The term “detoxification treatment” means the dispensing, for a period not in excess of one hundred and eighty days, of a [narcotic drug](#17) in decreasing doses to an individual in order to alleviate adverse physiological or psychological effects incident to withdrawal from the continuous or sustained use of a [narcotic drug](#17) and as a method of bringing the individual to a [narcotic drug](#17)-free [state](#26) within such period. - (31) The term “Convention on Psychotropic Substances” means the Convention on Psychotropic Substances signed at Vienna, Austria, on February 21, 1971; and the term “Single Convention on Narcotic Drugs” means the Single Convention on Narcotic Drugs signed at New York, New York, on March 30, 1961. - (32) - (A) Except as provided in [subparagraph (C)](#32-C), the term “controlled substance analogue” means a substance— - (i) the chemical structure of which is substantially similar to the chemical structure of a [controlled substance](#6) in schedule I or II; - (ii) which has a stimulant, depressant, or hallucinogenic effect on the central nervous system that is substantially similar to or greater than the stimulant, depressant, or hallucinogenic effect on the central nervous system of a [controlled substance](#6) in schedule I or II; or - (iii) with respect to a particular [person](/usc/21/379j–21.md?p=k-10), which such [person](/usc/21/379j–21.md?p=k-10) represents or intends to have a stimulant, depressant, or hallucinogenic effect on the central nervous system that is substantially similar to or greater than the stimulant, depressant, or hallucinogenic effect on the central nervous system of a [controlled substance](#6) in schedule I or II. - (B) The designation of gamma butyrolactone or any other chemical as a [listed chemical](#33) pursuant to paragraph [(34)](#34) or [(35)](#35) does not preclude a finding pursuant to subparagraph (A) of this paragraph that the chemical is a [controlled substance analogue](#32-A). - (C) Such term does not include— - (i) a [controlled substance](#6); - (ii) any substance for which there is an approved new [drug](/usc/21/321.md?p=g-1) application; - (iii) with respect to a particular [person](/usc/21/379j–21.md?p=k-10) any substance, if an exemption is in effect for investigational use, for that [person](/usc/21/379j–21.md?p=k-10), under [section 355 of this title](/usc/21/355.md) to the extent conduct with respect to such substance is pursuant to such exemption; or - (iv) any substance to the extent not intended for human consumption before such an exemption takes effect with respect to that substance. - (33) The term “listed chemical” means any [list I chemical](#34) or any [list II chemical](#35). - (34) The term “list I chemical” means a chemical specified by regulation of the Attorney General as a chemical that is used in manufacturing a [controlled substance](#6) in violation of this subchapter and is important to the [manufacture](#15) of the [controlled substances](#6), and such term includes (until otherwise specified by regulation of the Attorney General, as considered appropriate by the Attorney General or upon petition to the Attorney General by any [person](/usc/21/379j–21.md?p=k-10)) the following: - (A) Anthranilic acid, its esters, and its salts. - (B) Benzyl cyanide. - (C) Ephedrine, its salts, optical [isomers](#14), and salts of optical [isomers](#14). - (D) Ergonovine and its salts. - (E) Ergotamine and its salts. - (F) N-Acetylanthranilic acid, its esters, and its salts. - (G) Norpseudoephedrine, its salts, optical [isomers](#14), and salts of optical [isomers](#14). - (H) Phenylacetic acid, its esters, and its salts. - (I) Phenylpropanolamine, its salts, optical [isomers](#14), and salts of optical [isomers](#14). - (J) Piperidine and its salts. - (K) Pseudoephedrine, its salts, optical [isomers](#14), and salts of optical [isomers](#14). - (L) 3,4-Methylenedioxyphenyl-2-propanone. - (M) Methylamine. - (N) Ethylamine. - (O) Propionic anhydride. - (P) Isosafrole. - (Q) Safrole. - (R) Piperonal. - (S) N-Methylephedrine. - (T) N-methylpseudoephedrine. - (U) Hydriodic acid. - (V) Benzaldehyde. - (W) Nitroethane. - (X) Gamma butyrolactone. - (Y) Any salt, optical [isomer](#14), or salt of an optical [isomer](#14) of the chemicals listed in [subparagraphs (M) through (U)](#M..U) of this paragraph. - (35) The term “list II chemical” means a chemical (other than a [list I chemical](#34)) specified by regulation of the Attorney General as a chemical that is used in manufacturing a [controlled substance](#6) in violation of this subchapter, and such term includes (until otherwise specified by regulation of the Attorney General, as considered appropriate by the Attorney General or upon petition to the Attorney General by any [person](/usc/21/379j–21.md?p=k-10)) the following chemicals: - (A) Acetic anhydride. - (B) Acetone. - (C) Benzyl chloride. - (D) Ethyl ether. - (E) Repealed. Pub. L. 101–647, title XXIII, § 2301(b), Nov. 29, 1990, 104 Stat. 4858. - (F) Potassium permanganate. - (G) 2-Butanone (or Methyl Ethyl Ketone). - (H) Toluene. - (I) Iodine. - (J) Hydrochloric gas. - (36) The term “regular customer” means, with respect to a [regulated person](#38), a customer with whom the [regulated person](#38) has an established business relationship that is reported to the Attorney General. - (37) The term “regular importer” means, with respect to a [listed chemical](#33), a [person](/usc/21/379j–21.md?p=k-10) that has an established record as an importer of that [listed chemical](#33) that is reported to the Attorney General. - (38) The term “regulated person” means a [person](/usc/21/379j–21.md?p=k-10) who [manufactures](#15), [distributes](#11), imports, or exports a [listed chemical](#33), a tableting machine, or an encapsulating machine or who acts as a [broker](#43) or [trader](#43) for an [international transaction](#42) involving a [listed chemical](#33), a tableting machine, or an encapsulating machine. - (39) The term “regulated transaction” means— - (A) a [distribution](/usc/21/360eee.md?p=5), receipt, sale, importation, or exportation of, or an [international transaction](#42) involving shipment of, a [listed chemical](#33), or if the Attorney General establishes a threshold amount for a specific [listed chemical](#33), a threshold amount, including a cumulative threshold amount for multiple transactions (as determined by the Attorney General, in consultation with the chemical industry and taking into consideration the quantities normally used for lawful purposes), of a [listed chemical](#33), except that such term does not include— - (i) a domestic lawful [distribution](/usc/21/360eee.md?p=5) in the usual course of business between [agents](#3) or employees of a single [regulated person](#38); - (ii) a [delivery](#8) of a [listed chemical](#33) to or by a common or contract carrier for carriage in the lawful and usual course of the business of the common or contract carrier, or to or by a warehouseman for storage in the lawful and usual course of the business of the warehouseman, except that if the carriage or storage is in connection with the [distribution](/usc/21/360eee.md?p=5), importation, or exportation of a [listed chemical](#33) to a third [person](/usc/21/379j–21.md?p=k-10), this clause does not relieve a [distributor](#11), importer, or exporter from compliance with [section 830 of this title](/usc/21/830.md); - (iii) any category of transaction or any category of transaction for a specific [listed chemical](#33) or chemicals specified by regulation of the Attorney General as excluded from this definition as unnecessary for enforcement of this subchapter or subchapter II; - (iv) any transaction in a [listed chemical](#33) that is contained in a [drug](/usc/21/321.md?p=g-1) that may be marketed or distributed lawfully in the [United States](#28) under the Federal [Food](/usc/21/346a.md?p=a-1), [Drug](/usc/21/321.md?p=g-1), and Cosmetic Act [[21 U.S.C. 301](/usc/21/301.md) et seq.], subject to [clause (v)](#39-A-v), unless— - (I) the Attorney General has determined under [section 814 of this title](/usc/21/814.md) that the [drug](/usc/21/321.md?p=g-1) or group of [drugs](/usc/21/321.md?p=g-1) is being diverted to obtain the [listed chemical](#33) for use in the illicit [production](#22) of a [controlled substance](#6); and - (II) the quantity of the [listed chemical](#33) contained in the [drug](/usc/21/321.md?p=g-1) included in the transaction or multiple transactions equals or exceeds the threshold established for that chemical by the Attorney General; - (v) any transaction in a [scheduled listed chemical product](#45-A) that is a sale [at retail](#48) by a [regulated seller](#46) or a [distributor](#11) required to submit reports under [section 830(b)(3) of this title](/usc/21/830.md?p=b-3); or - (vi) any transaction in a [chemical mixture](#40) which the Attorney General has by regulation designated as exempt from the application of this subchapter and subchapter II based on a finding that the mixture is formulated in such a way that it cannot be easily used in the illicit [production](#22) of a [controlled substance](#6) and that the [listed chemical](#33) or chemicals contained in the mixture cannot be readily recovered; and - (B) a [distribution](/usc/21/360eee.md?p=5), importation, or exportation of a tableting machine or encapsulating machine. - (40) The term “chemical mixture” means a combination of two or more chemical substances, at least one of which is not a [list I chemical](#34) or a [list II chemical](#35), except that such term does not include any combination of a [list I chemical](#34) or a [list II chemical](#35) with another chemical that is present solely as an impurity. - (41) - (A) The term “anabolic steroid” means any [drug](/usc/21/321.md?p=g-1) or hormonal substance, chemically and pharmacologically related to testosterone (other than estrogens, progestins, corticosteroids, and dehydroepiandrosterone), and includes— - (i) androstanediol— - (I) 3β,17β-dihydroxy-5α-androstane; and - (II) 3α,17β-dihydroxy-5α-androstane; - (ii) androstanedione (5α-androstan-3,17-dione); - (iii) androstenediol— - (I) 1-androstenediol (3β,17β-dihydroxy-5α-androst-1-ene); - (II) 1-androstenediol (3α,17β-dihydroxy-5α-androst-1-ene); - (III) 4-androstenediol (3β,17β-dihydroxy-androst-4-ene); and - (IV) 5-androstenediol (3β,17β-dihydroxy-androst-5-ene); - (iv) androstenedione— - (I) 1-androstenedione ([5α]-androst-1-en-3,17-dione); - (II) 4-androstenedione (androst-4-en-3,17-dione); and - (III) 5-androstenedione (androst-5-en-3,17-dione); - (v) bolasterone (7α,17α-dimethyl-17β-hydroxyandrost-4-en-3-one); - (vi) boldenone (17β-hydroxyandrost-1,4,-diene-3-one); - (vii) calusterone (7β,17α-dimethyl-17β-hydroxyandrost-4-en-3-one); - (viii) clostebol (4-chloro-17β-hydroxyandrost-4-en-3-one); - (ix) dehydrochloromethyltestosterone (4-chloro-17β-hydroxy-17α-methyl-androst-1,4-dien-3-one); - (x) *1-dihydrotestosterone (a.k.a. “1-testosterone”) (17β-hydroxy-5α-androst-1-en-3-one); - (xi) 4-dihydrotestosterone (17β-hydroxy-androstan-3-one); - (xii) drostanolone (17β-hydroxy-2α-methyl-5α-androstan-3-one); - (xiii) ethylestrenol (17α-ethyl-17β-hydroxyestr-4-ene); - (xiv) fluoxymesterone (9-fluoro-17α-methyl-11β,17β-dihydroxyandrost-4-en-3-one); - (xv) formebolone (2-formyl-17α-methyl-11α,17β-dihydroxyandrost-1,4-dien-3-one); - (xvi) furazabol (17α-methyl-17β-hydroxyandrostano[2,3-c]-furazan); - (xvii) 13β-ethyl-17β-hydroxygon-4-en-3-one; - (xviii) 4-hydroxytestosterone (4,17β-dihydroxy-androst-4-en-3-one); - (xix) 4-hydroxy-19-nortestosterone (4,17β-dihydroxy-estr-4-en-3-one); - (xx) mestanolone (17α-methyl-17β-hydroxy-5α-androstan-3-one); - (xxi) mesterolone (1α-methyl-17β-hydroxy-[5α]-androstan-3-one); - (xxii) methandienone (17α-methyl-17β-hydroxyandrost-1,4-dien-3-one); - (xxiii) methandriol (17α-methyl-3β,17β-dihydroxyandrost-5-ene); - (xxiv) methenolone (1-methyl-17β-hydroxy-5α-androst-1-en-3-one); - (xxv) 17α-methyl-3β, 17β-dihydroxy-5α-androstane; - (xxvi) 17α-methyl-3α,17β-dihydroxy-5α-androstane; - (xxvii) 17α-methyl-3β,17β-dihydroxyandrost-4-ene. - (xxviii) 17α-methyl-4-hydroxynandrolone (17α-methyl-4-hydroxy-17β-hydroxyestr-4-en-3-one); - (xxix) methyldienolone (17α-methyl-17β-hydroxyestra-4,9(10)-dien-3-one); - (xxx) methyltrienolone (17α-methyl-17β-hydroxyestra-4,9-11-trien-3-one); - (xxxi) methyltestosterone (17α-methyl-17β-hydroxyandrost-4-en-3-one); - (xxxii) mibolerone (7α,17α-dimethyl-17β-hydroxyestr-4-en-3-one); - (xxxiii) 17α-methyl-*1-dihydrotestosterone (17β-hydroxy-17α-methyl-5α-androst-1-en-3-one) (a.k.a. “17-α-methyl-1-testosterone”); - (xxxiv) nandrolone (17β-hydroxyestr-4-en-3-one); - (xxxv) norandrostenediol— - (I) 19-nor-4-androstenediol (3β, 17β-dihydroxyestr-4-ene); - (II) 19-nor-4-androstenediol (3α, 17β-dihydroxyestr-4-ene); - (III) 19-nor-5-androstenediol (3β, 17β-dihydroxyestr-5-ene); and - (IV) 19-nor-5-androstenediol (3α, 17β-dihydroxyestr-5-ene); - (xxxvi) norandrostenedione— - (I) 19-nor-4-androstenedione (estr-4-en-3,17-dione); and - (II) 19-nor-5-androstenedione (estr-5-en-3,17-dione; - (xxxvii) norbolethone (13β,17α-diethyl-17β-hydroxygon-4-en-3-one); - (xxxviii) norclostebol (4-chloro-17β-hydroxyestr-4-en-3-one); - (xxxix) norethandrolone (17α-ethyl-17β-hydroxyestr-4-en-3-one); - (xl) normethandrolone (17α-methyl-17β-hydroxyestr-4-en-3-one); - (xli) oxandrolone (17α-methyl-17β-hydroxy-2-oxa-[5α]-androstan-3-one); - (xlii) oxymesterone (17α-methyl-4,17β-dihydroxyandrost-4-en-3-one); - (xliii) oxymetholone (17α-methyl-2-hydroxymethylene-17β-hydroxy-[5α]-androstan-3-one); - (xliv) stanozolol (17α-methyl-17β-hydroxy-[5α]-androst-2-eno[3,2-c]-pyrazole); - (xlv) stenbolone (17β-hydroxy-2-methyl-[5α]-androst-1-en-3-one); - (xlvi) testolactone (13-hydroxy-3-oxo-13,17-secoandrosta-1,4-dien-17-oic acid lactone); - (xlvii) testosterone (17β-hydroxyandrost-4-en-3-one); - (xlviii) tetrahydrogestrinone (13β,17α-diethyl-17β-hydroxygon-4,9,11-trien-3-one); - (xlix) trenbolone (17β-hydroxyestr-4,9,11-trien-3-one); - (l) 5α-Androstan-3,6,17-trione; - (li) 6-bromo-androstan-3,17-dione; - (lii) 6-bromo-androsta-1,4-diene-3,17-dione; - (liii) 4-chloro-17α-methyl-androsta-1,4-diene-3,17β-diol; - (liv) 4-chloro-17α-methyl-androst-4-ene-3β,17β-diol; - (lv) 4-chloro-17α-methyl-17β-hydroxy-androst-4-en-3-one; - (lvi) 4-chloro-17α-methyl-17β-hydroxy-androst-4-ene-3,11-dione; - (lvii) 4-chloro-17α-methyl-androsta-1,4-diene-3,17β-diol; - (lviii) 2α,17α-dimethyl-17β-hydroxy-5α-androstan-3-one; - (lix) 2α,17α-dimethyl-17β-hydroxy-5β-androstan-3-one; - (lx) 2α,3α-epithio-17α-methyl-5α-androstan-17β-ol; - (lxi) [3,2-c]-furazan-5α-androstan-17β-ol; - (lxii) 3β-hydroxy-estra-4,9,11-trien-17-one; - (lxiii) 17α-methyl-androst-2-ene-3,17β-diol; - (lxiv) 17α-methyl-androsta-1,4-diene-3,17β-diol; - (lxv) Estra-4,9,11-triene-3,17-dione; - (lxvi) 18a-Homo-3-hydroxy-estra-2,5(10)-dien-17-one; - (lxvii) 6α-Methyl-androst-4-ene-3,17-dione; - (lxviii) 17α-Methyl-androstan-3-hydroxyimine-17β-ol; - (lxix) 17α-Methyl-5α-androstan-17β-ol; - (lxx) 17β-Hydroxy-androstano[2,3-d]isoxazole; - (lxxi) 17β-Hydroxy-androstano[3,2-c]isoxazole; - (lxxii) 4-Hydroxy-androst-4-ene-3,17-dione[3,2-c]pyrazole-5α-androstan-17β-ol; - (lxxiii) [3,2-c]pyrazole-androst-4-en-17β-ol; - (lxxiv) [3,2-c]pyrazole-5α-androstan-17β-ol; and - (lxxv) any salt, ester, or ether of a [drug](/usc/21/321.md?p=g-1) or substance described in this paragraph. The substances excluded under this subparagraph may at any time be scheduled by the Attorney General in accordance with the authority and requirements of subsections (a) through (c) of [section 811 of this title](/usc/21/811.md). - (B) - (i) Except as provided in [clause (ii)](#41-B-ii), such term does not include an [anabolic steroid](#41-A) which is expressly intended for administration through implants to cattle or other nonhuman species and which has been approved by the [Secretary](#24) of Health and Human Services for such administration. - (ii) If any [person](/usc/21/379j–21.md?p=k-10) prescribes, [dispenses](#10), or [distributes](#11) such steroid for human use, such [person](/usc/21/379j–21.md?p=k-10) shall be considered to have prescribed, dispensed, or distributed an [anabolic steroid](#41-A) within the meaning of [subparagraph (A)](#41-A). - (C) - (i) Subject to [clause (ii)](#41-C-ii), a [drug](/usc/21/321.md?p=g-1) or hormonal substance (other than estrogens, progestins, corticosteroids, and dehydroepiandrosterone) that is not listed in [subparagraph (A)](#41-A) and is derived from, or has a chemical structure substantially similar to, 1 or more [anabolic steroids](#41-A) listed in [subparagraph (A)](#41-A) shall be considered to be an [anabolic steroid](#41-A) for purposes of this chapter if— - (I) the [drug](/usc/21/321.md?p=g-1) or substance has been created or manufactured with the intent of producing a [drug](/usc/21/321.md?p=g-1) or other substance that either— - (aa) promotes muscle growth; or - (bb) otherwise causes a pharmacological effect similar to that of testosterone; or - (II) the [drug](/usc/21/321.md?p=g-1) or substance has been, or is intended to be, marketed or otherwise promoted in any manner suggesting that consuming it will promote muscle growth or any other pharmacological effect similar to that of testosterone. - (ii) A substance shall not be considered to be a [drug](/usc/21/321.md?p=g-1) or hormonal substance for purposes of this subparagraph if it— - (I) is— - (aa) an herb or other botanical; - (bb) a concentrate, metabolite, or extract of, or a constituent isolated directly from, an herb or other botanical; or - (cc) a combination of 2 or more substances described in item [(aa)](#41-C-ii-I-aa) or [(bb)](#41-C-ii-I-bb); - (II) is a dietary ingredient for purposes of the Federal [Food](/usc/21/346a.md?p=a-1), [Drug](/usc/21/321.md?p=g-1), and Cosmetic Act ([21 U.S.C. 301](/usc/21/301.md) et seq.); and - (III) is not anabolic or androgenic. - (iii) In accordance with [section 885(a) of this title](/usc/21/885.md?p=a), any [person](/usc/21/379j–21.md?p=k-10) claiming the benefit of an exemption or exception under [clause (ii)](#41-C-ii) shall bear the burden of going forward with the evidence with respect to such exemption or exception. - (42) The term “international transaction” means a transaction involving the shipment of a [listed chemical](#33) across an international border (other than a [United States](#28) border) in which a [broker](#43) or [trader](#43) located in the [United States](#28) participates. - (43) The terms “broker” and “trader” mean a [person](/usc/21/379j–21.md?p=k-10) that assists in arranging an [international transaction](#42) in a [listed chemical](#33) by— - (A) negotiating contracts; - (B) serving as an [agent](#3) or intermediary; or - (C) bringing together a buyer and seller, a buyer and transporter, or a seller and transporter. - (44) The term “felony drug offense” means an offense that is punishable by imprisonment for more than one year under any law of the [United States](#28) or of a [State](#26) or foreign country that prohibits or restricts conduct relating to [narcotic drugs](#17), [marihuana](#16-A), [anabolic steroids](#41-A), or [depressant or stimulant substances](#9). - (45) - (A) The term “scheduled listed chemical product” means, subject to [subparagraph (B)](#45-B), a product that— - (i) contains ephedrine, pseudoephedrine, or phenylpropanolamine; and - (ii) may be marketed or distributed lawfully in the [United States](#28) under the Federal, [Food](/usc/21/346a.md?p=a-1), [Drug](/usc/21/321.md?p=g-1), and Cosmetic Act [[21 U.S.C. 301](/usc/21/301.md) et seq.] as a [nonprescription drug](/usc/21/355h.md?p=q-1). Each reference in [clause (i)](#45-A-i) to ephedrine, pseudoephedrine, or phenylpropanolamine includes each of the salts, optical [isomers](#14), and salts of optical [isomers](#14) of such chemical. - (B) Such term does not include a product described in [subparagraph (A)](#45-A) if the product contains a chemical specified in such subparagraph that the Attorney General has under [section 811(a) of this title](/usc/21/811.md?p=a) added to any of the schedules under [section 812(c) of this title](/usc/21/812.md?p=c). In the absence of such scheduling by the Attorney General, a chemical specified in such subparagraph may not be considered to be a [controlled substance](#6). - (46) The term “regulated seller” means a [retail distributor](#49-A) (including a pharmacy or a [mobile retail vendor](#47)), except that such term does not include an employee or [agent](#3) of such [distributor](#11). - (47) The term “mobile retail vendor” means a [person](/usc/21/379j–21.md?p=k-10) or entity that makes sales [at retail](#48) from a stand that is intended to be temporary, or is capable of being moved from one location to another, whether the stand is located within or on the premises of a fixed [facility](/usc/21/350g.md?p=o-2) (such as a kiosk at a shopping center or an airport) or whether the stand is located on unimproved real estate (such as a lot or field leased for retail purposes). - (48) The term “at retail”, with respect to the sale or purchase of a [scheduled listed chemical product](#45-A), means a sale or purchase for personal use, respectively. - (49) - (A) The term “retail distributor” means a grocery store, general merchandise store, [drug](/usc/21/321.md?p=g-1) store, or other entity or [person](/usc/21/379j–21.md?p=k-10) whose activities as a [distributor](#11) relating to ephedrine, pseudoephedrine, or phenylpropanolamine products are limited almost exclusively to sales for personal use, both in number of sales and volume of sales, either directly to walk-in customers or in face-to-face transactions by direct sales. - (B) For purposes of this paragraph, entities are defined by reference to the Standard Industrial Classification (SIC) code, as follows: - (i) A grocery store is an entity within SIC code 5411. - (ii) A general merchandise store is an entity within SIC codes 5300 through 5399 and 5499. - (iii) A [drug](/usc/21/321.md?p=g-1) store is an entity within SIC code 5912. - (50) The term “Internet” means collectively the myriad of computer and telecommunications [facilities](/usc/21/350g.md?p=o-2), including equipment and operating software, which comprise the interconnected worldwide network of networks that employ the Transmission [Control](#5) Protocol/Internet Protocol, or any predecessor or successor protocol to such protocol, to communicate information of all kinds by wire or radio. - (51) The term “deliver, distribute, or dispense by means of the Internet” refers, respectively, to any [delivery](#8), [distribution](/usc/21/360eee.md?p=5), or dispensing of a [controlled substance](#6) that is caused or facilitated by means of the [Internet](#50). - (52) The term “online pharmacy”— - (A) means a [person](/usc/21/379j–21.md?p=k-10), entity, or [Internet](#50) site, whether in the [United States](#28) or abroad, that knowingly or intentionally [delivers](#8), [distributes](#11), or [dispenses](#10), or offers or attempts to [deliver](#8), [distribute](#11), or [dispense](#10), a [controlled substance](#6) by means of the [Internet](#50); and - (B) does not include— - (i) [manufacturers](#15) or [distributors](#11) registered under subsection (a), (b), (e), or (f) of [section 823 of this title](/usc/21/823.md) who do not [dispense](#10) [controlled substances](#6) to an unregistered individual or entity; - (ii) nonpharmacy [practitioners](#21) who are registered under [section 823(g) of this title](/usc/21/823.md?p=g) and whose activities are [authorized](/usc/21/360eee–1.md?p=a-6) by that registration; - (iii) any hospital or other medical [facility](/usc/21/350g.md?p=o-2) that is operated by an agency of the [United States](#28) (including the Armed Forces), provided such hospital or other [facility](/usc/21/350g.md?p=o-2) is registered under [section 823(g) of this title](/usc/21/823.md?p=g); - (iv) a health care [facility](/usc/21/350g.md?p=o-2) owned or operated by an Indian tribe or tribal organization, only to the extent such [facility](/usc/21/350g.md?p=o-2) is carrying out a contract or compact under the Indian Self-Determination and Education Assistance Act [[25 U.S.C. 5301](/usc/25/5301.md) et seq.]; - (v) any [agent](#3) or employee of any hospital or [facility](/usc/21/350g.md?p=o-2) referred to in clause [(iii)](#52-B-iii) or [(iv)](#52-B-iv), provided such [agent](#3) or employee is lawfully acting in the usual course of business or employment, and within the scope of the official duties of such [agent](#3) or employee, with such hospital or [facility](/usc/21/350g.md?p=o-2), and, with respect to [agents](#3) or employees of health care [facilities](/usc/21/350g.md?p=o-2) specified in [clause (iv)](#52-B-iv), only to the extent such individuals are furnishing services pursuant to the contracts or compacts described in such clause; - (vi) mere advertisements that do not attempt to facilitate an actual transaction involving a [controlled substance](#6); - (vii) a [person](/usc/21/379j–21.md?p=k-10), entity, or [Internet](#50) site that is not in the [United States](#28) and does not facilitate the [delivery](#8), [distribution](/usc/21/360eee.md?p=5), or dispensing of a [controlled substance](#6) by means of the [Internet](#50) to any [person](/usc/21/379j–21.md?p=k-10) in the [United States](#28); - (viii) a pharmacy registered under [section 823(g) of this title](/usc/21/823.md?p=g) whose dispensing of [controlled substances](#6) via the [Internet](#50) consists solely of— - (I) [refilling prescriptions for controlled substances in schedule III, IV, or V](#55), as defined in [paragraph (55)](#55); or - (II) [filling new prescriptions for controlled substances in schedule III, IV, or V](#56), as defined in [paragraph (56)](#56); or - (ix) any other [persons](/usc/21/379j–21.md?p=k-10) for whom the Attorney General and the [Secretary](#24) have jointly, by regulation, found it to be consistent with effective [controls](#5) against diversion and otherwise consistent with the public health and safety to exempt from the definition of an “[online pharmacy](#52)”. - (53) The term “homepage” means the opening or main page or screen of the website of an [online pharmacy](#52) that is viewable on the [Internet](#50). - (54) The term “practice of telemedicine” means, for purposes of this subchapter, the practice of medicine in accordance with applicable Federal and [State](#26) laws by a [practitioner](#21) (other than a pharmacist) who is at a location remote from the patient and is communicating with the patient, or health care professional who is treating the patient, using a telecommunications system referred to in [section 1395m(m) of title 42](/usc/42/1395m.md?p=m), which practice— - (A) is being conducted— - (i) while the patient is being treated by, and physically located in, a hospital or clinic registered under [section 823(g) of this title](/usc/21/823.md?p=g); and - (ii) by a [practitioner](#21)— - (I) acting in the usual course of professional practice; - (II) acting in accordance with applicable [State](#26) law; and - (III) registered under [section 823(g) of this title](/usc/21/823.md?p=g) in the [State](#26) in which the patient is located, unless the [practitioner](#21)— - (aa) is exempted from such registration in all [States](#26) under [section 822(d) of this title](/usc/21/822.md?p=d); or - (bb) is— - (AA) an employee or contractor of the Department of Veterans Affairs who is acting in the scope of such employment or contract; and - (BB) registered under [section 823(g) of this title](/usc/21/823.md?p=g) in any [State](#26) or is utilizing the registration of a hospital or clinic operated by the Department of Veterans Affairs registered under [section 823(g) of this title](/usc/21/823.md?p=g); - (B) is being conducted while the patient is being treated by, and in the physical presence of, a [practitioner](#21)— - (i) acting in the usual course of professional practice; - (ii) acting in accordance with applicable [State](#26) law; and - (iii) registered under [section 823(g) of this title](/usc/21/823.md?p=g) in the [State](#26) in which the patient is located, unless the [practitioner](#21)— - (I) is exempted from such registration in all [States](#26) under [section 822(d) of this title](/usc/21/822.md?p=d); or - (II) is— - (aa) an employee or contractor of the Department of Veterans Affairs who is acting in the scope of such employment or contract; and - (bb) registered under [section 823(g) of this title](/usc/21/823.md?p=g) in any [State](#26) or is using the registration of a hospital or clinic operated by the Department of Veterans Affairs registered under [section 823(g) of this title](/usc/21/823.md?p=g); - (C) is being conducted by a [practitioner](#21)— - (i) who is an employee or contractor of the Indian Health Service, or is working for an Indian tribe or tribal organization under its contract or compact with the Indian Health Service under the Indian Self-Determination and Education Assistance Act [[25 U.S.C. 5301](/usc/25/5301.md) et seq.]; - (ii) acting within the scope of the employment, contract, or compact described in [clause (i)](#54-C-i); and - (iii) who is designated as an [Internet](#50) Eligible [Controlled Substances](#6) Provider by the [Secretary](#24) under [section 831(g)(2) of this title](/usc/21/831.md?p=g-2); - (D) - (i) is being conducted during a public health emergency declared by the [Secretary](#24) under [section 247d of title 42](/usc/42/247d.md); and - (ii) involves patients located in such areas, and such [controlled substances](#6), as the [Secretary](#24), with the concurrence of the Attorney General, designates, provided that such designation shall not be subject to the procedures prescribed by subchapter II of [chapter 5](/usc/5/chptI-ch5.md) of title 5; - (E) is being conducted by a [practitioner](#21) who has obtained from the Attorney General a special registration under [section 831(h) of this title](/usc/21/831.md?p=h); - (F) is being conducted— - (i) in a medical emergency situation— - (I) that prevents the patient from being in the physical presence of a [practitioner](#21) registered under [section 823(g) of this title](/usc/21/823.md?p=g) who is an employee or contractor of the Veterans Health Administration acting in the usual course of business and employment and within the scope of the official duties or contract of that employee or contractor; - (II) that prevents the patient from being physically present at a hospital or clinic operated by the Department of Veterans Affairs registered under [section 823(g) of this title](/usc/21/823.md?p=g); - (III) during which the primary care [practitioner](#21) of the patient or a [practitioner](#21) otherwise practicing telemedicine within the meaning of this paragraph is unable to provide care or consultation; and - (IV) that requires immediate intervention by a health care [practitioner](#21) using [controlled substances](#6) to prevent what the [practitioner](#21) reasonably believes in good faith will be imminent and serious clinical consequences, such as further injury or death; and - (ii) by a [practitioner](#21) that— - (I) is an employee or contractor of the Veterans Health Administration acting within the scope of that employment or contract; - (II) is registered under [section 823(g) of this title](/usc/21/823.md?p=g) in any [State](#26) or is utilizing the registration of a hospital or clinic operated by the Department of Veterans Affairs registered under [section 823(g) of this title](/usc/21/823.md?p=g); and - (III) issues a [controlled substance](#6) prescription in this emergency context that is limited to a maximum of a 5-day supply which may not be extended or refilled; or - (G) is being conducted under any other circumstances that the Attorney General and the [Secretary](#24) have jointly, by regulation, determined to be consistent with effective [controls](#5) against diversion and otherwise consistent with the public health and safety. - (55) The term “refilling prescriptions for controlled substances in schedule III, IV, or V”— - (A) means the dispensing of a [controlled substance](#6) in schedule III, IV, or V in accordance with refill instructions issued by a [practitioner](#21) as part of a valid prescription that meets the requirements of subsections (b) and (c) of [section 829 of this title](/usc/21/829.md), as appropriate; and - (B) does not include the issuance of a new prescription to an individual for a [controlled substance](#6) that individual was previously prescribed. - (56) The term “filling new prescriptions for controlled substances in schedule III, IV, or V” means filling a prescription for an individual for a [controlled substance](#6) in schedule III, IV, or V, if— - (A) the pharmacy dispensing that prescription has previously dispensed to the patient a [controlled substance](#6) other than by means of the [Internet](#50) and pursuant to the valid prescription of a [practitioner](#21) that meets the applicable requirements of subsections (b) and (c) of [section 829 of this title](/usc/21/829.md) (in this paragraph referred to as the “original prescription”); - (B) the pharmacy contacts the [practitioner](#21) who issued the original prescription at the request of that individual to determine whether the [practitioner](#21) will authorize the issuance of a new prescription for that individual for the [controlled substance](#6) described in [subparagraph (A)](#56-A); and - (C) the [practitioner](#21), acting in the usual course of professional practice, determines there is a legitimate medical purpose for the issuance of the new prescription. - (57) The term “suspicious order” may include, but is not limited to— - (A) an order of a [controlled substance](#6) of unusual size; - (B) an order of a [controlled substance](#6) deviating substantially from a normal pattern; and - (C) orders of [controlled substances](#6) of unusual frequency. - (58) The term “serious drug felony” means an offense described in [section 924(e)(2) of title 18](/usc/18/924.md?p=e-2) for which— - (A) the offender served a term of imprisonment of more than 12 months; and - (B) the offender’s release from any term of imprisonment was within 15 years of the commencement of the instant offense. - (59) The term “serious violent felony” means— - (A) an offense described in [section 3559(c)(2) of title 18](/usc/18/3559.md?p=c-2) for which the offender served a term of imprisonment of more than 12 months; and - (B) any offense that would be a [felony](#13) violation of [section 113 of title 18](/usc/18/113.md), if the offense were committed in the special maritime and territorial jurisdiction of the [United States](#28), for which the offender served a term of imprisonment of more than 12 months. - (60) The term “fentanyl-related substance” has the meaning given the term in subsection (e)(2) of schedule I of [section 812(c) of this title](/usc/21/812.md?p=c). # [§803. Repealed. Pub. L. 95–137, § 1(b), Oct. 18, 1977, 91 Stat. 1169 — repealed] # §811. Authority and criteria for classification of substances - (a) **Rules and regulations of Attorney General; hearing—** The Attorney General shall apply the provisions of this subchapter to the [controlled substances](/usc/21/802.md?p=6) listed in the schedules established by [section 812 of this title](/usc/21/812.md) and to any other [drug](/usc/21/321.md?p=g-1) or other substance added to such schedules under this subchapter. Except as provided in subsections [(d)](#d) and [(e)](#e), the Attorney General may by rule— - (1) add to such a schedule or transfer between such schedules any [drug](/usc/21/321.md?p=g-1) or other substance if he— - (A) finds that such [drug](/usc/21/321.md?p=g-1) or other substance has a potential for abuse, and - (B) makes with respect to such [drug](/usc/21/321.md?p=g-1) or other substance the findings prescribed by subsection (b) of [section 812 of this title](/usc/21/812.md) for the schedule in which such [drug](/usc/21/321.md?p=g-1) is to be placed; or - (2) remove any [drug](/usc/21/321.md?p=g-1) or other substance from the schedules if he finds that the [drug](/usc/21/321.md?p=g-1) or other substance does not meet the requirements for inclusion in any schedule. Rules of the Attorney General under this subsection shall be made on the record after opportunity for a hearing pursuant to the rulemaking procedures prescribed by subchapter II of [chapter 5](/usc/5/chptI-ch5.md) of title 5. Proceedings for the issuance, amendment, or repeal of such rules may be initiated by the Attorney General (1) on his own motion, (2) at the request of the [Secretary](/usc/21/802.md?p=24), or (3) on the petition of any interested party. - (b) **Evaluation of drugs and other substances—** The Attorney General shall, before initiating proceedings under [subsection (a)](#a) to [control](/usc/21/802.md?p=5) a [drug](/usc/21/321.md?p=g-1) or other substance or to remove a [drug](/usc/21/321.md?p=g-1) or other substance entirely from the schedules, and after gathering the necessary data, request from the [Secretary](/usc/21/802.md?p=24) a scientific and medical evaluation, and his recommendations, as to whether such [drug](/usc/21/321.md?p=g-1) or other substance should be so controlled or removed as a [controlled substance](/usc/21/802.md?p=6). In making such evaluation and recommendations, the [Secretary](/usc/21/802.md?p=24) shall consider the factors listed in paragraphs [(2)](#c-2), [(3)](#c-3), [(6)](#c-6), [(7)](#c-7), and [(8)](#c-8) of subsection (c) and any scientific or medical considerations involved in paragraphs [(1)](#c-1), [(4)](#c-4), and [(5)](#c-5) of such subsection. The recommendations of the [Secretary](/usc/21/802.md?p=24) shall include recommendations with respect to the appropriate schedule, if any, under which such [drug](/usc/21/321.md?p=g-1) or other substance should be listed. The evaluation and the recommendations of the [Secretary](/usc/21/802.md?p=24) shall be made in writing and submitted to the Attorney General within a reasonable time. The recommendations of the [Secretary](/usc/21/802.md?p=24) to the Attorney General shall be binding on the Attorney General as to such scientific and medical matters, and if the [Secretary](/usc/21/802.md?p=24) recommends that a [drug](/usc/21/321.md?p=g-1) or other substance not be controlled, the Attorney General shall not [control](/usc/21/802.md?p=5) the [drug](/usc/21/321.md?p=g-1) or other substance. If the Attorney General determines that these facts and all other relevant data constitute substantial evidence of potential for abuse such as to warrant [control](/usc/21/802.md?p=5) or substantial evidence that the [drug](/usc/21/321.md?p=g-1) or other substance should be removed entirely from the schedules, he shall initiate proceedings for [control](/usc/21/802.md?p=5) or removal, as the case may be, under [subsection (a)](#a). - (c) **Factors determinative of control or removal from schedules—** In making any finding under [subsection (a)](#a) of this section or under subsection (b) of [section 812 of this title](/usc/21/812.md), the Attorney General shall consider the following factors with respect to each [drug](/usc/21/321.md?p=g-1) or other substance proposed to be controlled or removed from the schedules: - (1) Its actual or relative potential for abuse. - (2) Scientific evidence of its pharmacological effect, if known. - (3) The [state](/usc/21/802.md?p=26) of current scientific knowledge regarding the [drug](/usc/21/321.md?p=g-1) or other substance. - (4) Its history and current pattern of abuse. - (5) The scope, duration, and significance of abuse. - (6) What, if any, risk there is to the public health. - (7) Its psychic or physiological dependence liability. - (8) Whether the substance is an [immediate precursor](/usc/21/802.md?p=23) of a substance already controlled under this subchapter. - (d) **International treaties, conventions, and protocols requiring control; procedures respecting changes in drug schedules of Convention on Psychotropic Substances—** - (1) If [control](/usc/21/802.md?p=5) is required by [United States](/usc/21/802.md?p=28) obligations under international treaties, conventions, or protocols in effect on October 27, 1970, the Attorney General shall issue an order controlling such [drug](/usc/21/321.md?p=g-1) under the schedule he deems most appropriate to carry out such obligations, without regard to the findings required by [subsection (a)](#a) of this section or [section 812(b) of this title](/usc/21/812.md?p=b) and without regard to the procedures prescribed by subsections [(a)](#a) and [(b)](#b) of this section. - (2) - (A) Whenever the Secretary of State receives notification from the [Secretary](/usc/21/802.md?p=24)-General of the United Nations that information has been transmitted by or to the World Health Organization, pursuant to article 2 of the [Convention on Psychotropic Substances](/usc/21/802.md?p=31), which may justify adding a [drug](/usc/21/321.md?p=g-1) or other substance to one of the schedules of the Convention, transferring a [drug](/usc/21/321.md?p=g-1) or substance from one schedule to another, or deleting it from the schedules, the Secretary of State shall immediately transmit the notice to the [Secretary](/usc/21/802.md?p=24) of Health and Human Services who shall publish it in the Federal Register and provide opportunity to interested [persons](/usc/21/379j–21.md?p=k-10) to submit to him comments respecting the scientific and medical evaluations which he is to prepare respecting such [drug](/usc/21/321.md?p=g-1) or substance. The [Secretary](/usc/21/802.md?p=24) of Health and Human Services shall prepare for transmission through the Secretary of State to the World Health Organization such medical and scientific evaluations as may be appropriate regarding the possible action that could be proposed by the World Health Organization respecting the [drug](/usc/21/321.md?p=g-1) or substance with respect to which a notice was transmitted under this subparagraph. - (B) Whenever the Secretary of State receives information that the Commission on [Narcotic Drugs](/usc/21/802.md?p=17) of the United Nations proposes to decide whether to add a [drug](/usc/21/321.md?p=g-1) or other substance to one of the schedules of the Convention, transfer a [drug](/usc/21/321.md?p=g-1) or substance from one schedule to another, or delete it from the schedules, the Secretary of State shall transmit timely notice to the [Secretary](/usc/21/802.md?p=24) of Health and Human Services of such information who shall publish a summary of such information in the Federal Register and provide opportunity to interested [persons](/usc/21/379j–21.md?p=k-10) to submit to him comments respecting the recommendation which he is to furnish, pursuant to this subparagraph, respecting such proposal. The [Secretary](/usc/21/802.md?p=24) of Health and Human Services shall evaluate the proposal and furnish a recommendation to the Secretary of State which shall be binding on the representative of the [United States](/usc/21/802.md?p=28) in discussions and negotiations relating to the proposal. - (3) When the [United States](/usc/21/802.md?p=28) receives notification of a scheduling decision pursuant to article 2 of the [Convention on Psychotropic Substances](/usc/21/802.md?p=31) that a [drug](/usc/21/321.md?p=g-1) or other substance has been added or transferred to a schedule specified in the notification or receives notification (referred to in this subsection as a “schedule notice”) that existing legal [controls](/usc/21/802.md?p=5) applicable under this subchapter to a [drug](/usc/21/321.md?p=g-1) or substance and the [controls](/usc/21/802.md?p=5) required by the Federal [Food](/usc/21/346a.md?p=a-1), [Drug](/usc/21/321.md?p=g-1), and Cosmetic Act [[21 U.S.C. 301](/usc/21/301.md) et seq.] do not meet the requirements of the schedule of the Convention in which such [drug](/usc/21/321.md?p=g-1) or substance has been placed, the [Secretary](/usc/21/802.md?p=24) of Health and Human Services after consultation with the Attorney General, shall first determine whether existing legal [controls](/usc/21/802.md?p=5) under this subchapter applicable to the [drug](/usc/21/321.md?p=g-1) or substance and the [controls](/usc/21/802.md?p=5) required by the Federal [Food](/usc/21/346a.md?p=a-1), [Drug](/usc/21/321.md?p=g-1), and Cosmetic Act, meet the requirements of the schedule specified in the notification or schedule notice and shall take the following action: - (A) If such requirements are met by such existing [controls](/usc/21/802.md?p=5) but the [Secretary](/usc/21/802.md?p=24) of Health and Human Services nonetheless believes that more stringent [controls](/usc/21/802.md?p=5) should be applied to the [drug](/usc/21/321.md?p=g-1) or substance, the [Secretary](/usc/21/802.md?p=24) shall recommend to the Attorney General that he initiate proceedings for scheduling the [drug](/usc/21/321.md?p=g-1) or substance, pursuant to subsections [(a)](#a) and [(b)](#b) of this section, to apply to such [controls](/usc/21/802.md?p=5). - (B) If such requirements are not met by such existing [controls](/usc/21/802.md?p=5) and the [Secretary](/usc/21/802.md?p=24) of Health and Human Services concurs in the scheduling decision or schedule notice transmitted by the notification, the [Secretary](/usc/21/802.md?p=24) shall recommend to the Attorney General that he initiate proceedings for scheduling the [drug](/usc/21/321.md?p=g-1) or substance under the appropriate schedule pursuant to subsections [(a)](#a) and [(b)](#b) of this section. - (C) If such requirements are not met by such existing [controls](/usc/21/802.md?p=5) and the [Secretary](/usc/21/802.md?p=24) of Health and Human Services does not concur in the scheduling decision or schedule notice transmitted by the notification, the [Secretary](/usc/21/802.md?p=24) shall— - (i) if he deems that additional [controls](/usc/21/802.md?p=5) are necessary to protect the public health and safety, recommend to the Attorney General that he initiate proceedings for scheduling the [drug](/usc/21/321.md?p=g-1) or substance pursuant to subsections [(a)](#a) and [(b)](#b) of this section, to apply such additional [controls](/usc/21/802.md?p=5); - (ii) request the Secretary of State to transmit a notice of qualified acceptance, within the period specified in the Convention, pursuant to paragraph 7 of article 2 of the Convention, to the [Secretary](/usc/21/802.md?p=24)-General of the United Nations; - (iii) request the Secretary of State to transmit a notice of qualified acceptance as prescribed in [clause (ii)](#d-3-C-ii) and request the Secretary of State to ask for a review by the Economic and Social [Council](/usc/21/2011.md?p=1) of the United Nations, in accordance with paragraph 8 of article 2 of the Convention, of the scheduling decision; or - (iv) in the case of a schedule notice, request the Secretary of State to take appropriate action under the Convention to initiate proceedings to remove the [drug](/usc/21/321.md?p=g-1) or substance from the schedules under the Convention or to transfer the [drug](/usc/21/321.md?p=g-1) or substance to a schedule under the Convention different from the one specified in the schedule notice. - (4) - (A) If the Attorney General determines, after consultation with the [Secretary](/usc/21/802.md?p=24) of Health and Human Services, that proceedings initiated under recommendations made under paragraph[^1] (B) or (C)(i) of [paragraph (3)](#d-3) will not be completed within the time period required by paragraph 7 of article 2 of the Convention, the Attorney General, after consultation with the [Secretary](/usc/21/802.md?p=24) and after providing interested [persons](/usc/21/379j–21.md?p=k-10) opportunity to submit comments respecting the requirements of the temporary order to be issued under this sentence, shall issue a temporary order controlling the [drug](/usc/21/321.md?p=g-1) or substance under schedule IV or V, whichever is most appropriate to carry out the minimum [United States](/usc/21/802.md?p=28) obligations under paragraph 7 of article 2 of the Convention. As a part of such order, the Attorney General shall, after consultation with the [Secretary](/usc/21/802.md?p=24), except such [drug](/usc/21/321.md?p=g-1) or substance from the application of any provision of part C of this subchapter which he finds is not required to carry out the [United States](/usc/21/802.md?p=28) obligations under paragraph 7 of article 2 of the Convention. In the case of proceedings initiated under [subparagraph (B)](#d-3-B) of paragraph (3), the Attorney General, concurrently with the issuance of such order, shall request the Secretary of State to transmit a notice of qualified acceptance to the [Secretary](/usc/21/802.md?p=24)-General of the United Nations pursuant to paragraph 7 of article 2 of the Convention. A temporary order issued under this subparagraph controlling a [drug](/usc/21/321.md?p=g-1) or other substance subject to proceedings initiated under subsections [(a)](#a) and [(b)](#b) of this section shall expire upon the effective date of the application to the [drug](/usc/21/321.md?p=g-1) or substance of the [controls](/usc/21/802.md?p=5) resulting from such proceedings. - (B) After a notice of qualified acceptance of a scheduling decision with respect to a [drug](/usc/21/321.md?p=g-1) or other substance is transmitted to the [Secretary](/usc/21/802.md?p=24)-General of the United Nations in accordance with clause [(ii)](#d-3-C-ii) or [(iii)](#d-3-C-iii) of paragraph (3)(C) or after a request has been made under [clause (iv)](#d-3-C-iv) of such paragraph with respect to a [drug](/usc/21/321.md?p=g-1) or substance described in a schedule notice, the Attorney General, after consultation with the [Secretary](/usc/21/802.md?p=24) of Health and Human Services and after providing interested [persons](/usc/21/379j–21.md?p=k-10) opportunity to submit comments respecting the requirements of the order to be issued under this sentence, shall issue an order controlling the [drug](/usc/21/321.md?p=g-1) or substance under schedule IV or V, whichever is most appropriate to carry out the minimum [United States](/usc/21/802.md?p=28) obligations under paragraph 7 of article 2 of the Convention in the case of a [drug](/usc/21/321.md?p=g-1) or substance for which a notice of qualified acceptance was transmitted or whichever the Attorney General determines is appropriate in the case of a [drug](/usc/21/321.md?p=g-1) or substance described in a schedule notice. As a part of such order, the Attorney General shall, after consultation with the [Secretary](/usc/21/802.md?p=24), except such [drug](/usc/21/321.md?p=g-1) or substance from the application of any provision of part C of this subchapter which he finds is not required to carry out the [United States](/usc/21/802.md?p=28) obligations under paragraph 7 of article 2 of the Convention. If, as a result of a review under paragraph 8 of article 2 of the Convention of the scheduling decision with respect to which a notice of qualified acceptance was transmitted in accordance with clause [(ii)](#d-3-C-ii) or [(iii)](#d-3-C-iii) of paragraph (3)(C)— - (i) the decision is reversed, and - (ii) the [drug](/usc/21/321.md?p=g-1) or substance subject to such decision is not required to be controlled under schedule IV or V to carry out the minimum [United States](/usc/21/802.md?p=28) obligations under paragraph 7 of article 2 of the Convention, the order issued under this subparagraph with respect to such [drug](/usc/21/321.md?p=g-1) or substance shall expire upon receipt by the [United States](/usc/21/802.md?p=28) of the review decision. If, as a result of action taken pursuant to action initiated under a request transmitted under [clause (iv)](#d-3-C-iv) of paragraph (3)(C), the [drug](/usc/21/321.md?p=g-1) or substance with respect to which such action was taken is not required to be controlled under schedule IV or V, the order issued under this paragraph with respect to such [drug](/usc/21/321.md?p=g-1) or substance shall expire upon receipt by the [United States](/usc/21/802.md?p=28) of a notice of the action taken with respect to such [drug](/usc/21/321.md?p=g-1) or substance under the Convention. - (C) An order issued under subparagraph [(A)](#d-4-A) or [(B)](#d-4-B) may be issued without regard to the findings required by [subsection (a)](#a) of this section or by [section 812(b) of this title](/usc/21/812.md?p=b) and without regard to the procedures prescribed by subsection [(a)](#a) or [(b)](#b) of this section. - (5) Nothing in the amendments made by the Psychotropic Substances Act of 1978 or the regulations or orders promulgated thereunder shall be construed to preclude requests by the [Secretary](/usc/21/802.md?p=24) of Health and Human Services or the Attorney General through the Secretary of State, pursuant to article 2 or other applicable provisions of the Convention, for review of scheduling decisions under such Convention, based on new or additional information. - (e) **Immediate precursors—** The Attorney General may, without regard to the findings required by [subsection (a)](#a) of this section or [section 812(b) of this title](/usc/21/812.md?p=b) and without regard to the procedures prescribed by subsections [(a)](#a) and [(b)](#b) of this section, place an [immediate precursor](/usc/21/802.md?p=23) in the same schedule in which the [controlled substance](/usc/21/802.md?p=6) of which it is an [immediate precursor](/usc/21/802.md?p=23) is placed or in any other schedule with a higher numerical designation. If the Attorney General designates a substance as an [immediate precursor](/usc/21/802.md?p=23) and places it in a schedule, other substances shall not be placed in a schedule solely because they are its precursors. - (f) **Abuse potential—** If, at the time a new-[drug](/usc/21/321.md?p=g-1) application is submitted to the [Secretary](/usc/21/802.md?p=24) for any [drug](/usc/21/321.md?p=g-1) having a stimulant, depressant, or hallucinogenic effect on the central nervous system, it appears that such [drug](/usc/21/321.md?p=g-1) has an abuse potential, such information shall be forwarded by the [Secretary](/usc/21/802.md?p=24) to the Attorney General. - (g) **Exclusion of non-narcotic substances sold over the counter without a prescription; dextromethorphan; exemption of substances lacking abuse potential—** - (1) The Attorney General shall by regulation exclude any non-[narcotic drug](/usc/21/802.md?p=17) which contains a [controlled substance](/usc/21/802.md?p=6) from the application of this subchapter and subchapter II of this chapter if such [drug](/usc/21/321.md?p=g-1) may, under the Federal [Food](/usc/21/346a.md?p=a-1), [Drug](/usc/21/321.md?p=g-1), and Cosmetic Act [[21 U.S.C. 301](/usc/21/301.md) et seq.], be lawfully sold over the counter without a prescription. - (2) Dextromethorphan shall not be deemed to be included in any schedule by reason of enactment of this subchapter unless controlled after October 27, 1970 pursuant to the foregoing provisions of this section. - (3) The Attorney General may, by regulation, exempt any compound, mixture, or preparation containing a [controlled substance](/usc/21/802.md?p=6) from the application of all or any part of this subchapter if he finds such compound, mixture, or preparation meets the requirements of one of the following categories: - (A) A mixture, or preparation containing a nonnarcotic [controlled substance](/usc/21/802.md?p=6), which mixture or preparation is approved for prescription use, and which contains one or more other active ingredients which are not listed in any schedule and which are included therein in such combinations, quantity, proportion, or concentration as to vitiate the potential for abuse. - (B) A compound, mixture, or preparation which contains any [controlled substance](/usc/21/802.md?p=6), which is not for administration to a human being or animal, and which is packaged in such form or concentration, or with adulterants or denaturants, so that as packaged it does not present any significant potential for abuse. - (C) Upon the recommendation of the [Secretary](/usc/21/802.md?p=24) of Health and Human Services, a compound, mixture, or preparation which contains any [anabolic steroid](/usc/21/802.md?p=41-A), which is intended for administration to a human being or an animal, and which, because of its concentration, preparation, formulation or [delivery](/usc/21/802.md?p=8) system, does not present any significant potential for abuse. - (h) **Temporary scheduling to avoid imminent hazards to public safety—** - (1) If the Attorney General finds that the scheduling of a substance in schedule I on a temporary basis is necessary to avoid an imminent hazard to the public safety, he may, by order and without regard to the requirements of [subsection (b)](#b) relating to the [Secretary](/usc/21/802.md?p=24) of Health and Human Services, schedule such substance in schedule I if the substance is not listed in any other schedule in [section 812 of this title](/usc/21/812.md) or if no exemption or approval is in effect for the substance under section 505 of the Federal [Food](/usc/21/346a.md?p=a-1), [Drug](/usc/21/321.md?p=g-1), and Cosmetic Act [[21 U.S.C. 355](/usc/21/355.md)]. Such an order may not be issued before the expiration of thirty days from— - (A) the date of the publication by the Attorney General of a notice in the Federal Register of the intention to issue such order and the grounds upon which such order is to be issued, and - (B) the date the Attorney General has transmitted the notice required by [paragraph (4)](#h-4). - (2) The scheduling of a substance under this subsection shall expire at the end of 2 years from the date of the issuance of the order scheduling such substance, except that the Attorney General may, during the pendency of proceedings under [subsection (a)(1)](#a-1) with respect to the substance, extend the temporary scheduling for up to 1 year. - (3) When issuing an order under [paragraph (1)](#h-1), the Attorney General shall be required to consider, with respect to the finding of an imminent hazard to the public safety, only those factors set forth in paragraphs [(4)](#c-4), [(5)](#c-5), and [(6)](#c-6) of subsection (c), including actual abuse, diversion from legitimate channels, and clandestine importation, [manufacture](/usc/21/802.md?p=15), or [distribution](/usc/21/360eee.md?p=5). - (4) The Attorney General shall transmit notice of an order proposed to be issued under [paragraph (1)](#h-1) to the [Secretary](/usc/21/802.md?p=24) of Health and Human Services. In issuing an order under [paragraph (1)](#h-1), the Attorney General shall take into consideration any comments submitted by the [Secretary](/usc/21/802.md?p=24) in response to a notice transmitted pursuant to this paragraph. - (5) An order issued under [paragraph (1)](#h-1) with respect to a substance shall be vacated upon the conclusion of a subsequent rulemaking proceeding initiated under [subsection (a)](#a) with respect to such substance. - (6) An order issued under [paragraph (1)](#h-1) is not subject to judicial review. - (i) **Temporary and permanent scheduling of recently emerged anabolic steroids—** - (1) The Attorney General may issue a temporary order adding a [drug](/usc/21/321.md?p=g-1) or other substance to the definition of [anabolic steroids](/usc/21/802.md?p=41-A) if the Attorney General finds that— - (A) the [drug](/usc/21/321.md?p=g-1) or other substance satisfies the criteria for being considered an [anabolic steroid](/usc/21/802.md?p=41-A) under [section 802(41) of this title](/usc/21/802.md?p=41) but is not listed in that section or by regulation of the Attorney General as being an [anabolic steroid](/usc/21/802.md?p=41-A); and - (B) adding such [drug](/usc/21/321.md?p=g-1) or other substance to the definition of [anabolic steroids](/usc/21/802.md?p=41-A) will assist in preventing abuse or misuse of the [drug](/usc/21/321.md?p=g-1) or other substance. - (2) An order issued under [paragraph (1)](#i-1) shall not take effect until 30 days after the date of the publication by the Attorney General of a notice in the Federal Register of the intention to issue such order and the grounds upon which such order is to be issued. The order shall expire not later than 24 months after the date it becomes effective, except that the Attorney General may, during the pendency of proceedings under [paragraph (6)](#i-6), extend the temporary scheduling order for up to 6 months. - (3) The Attorney General shall transmit notice of an order proposed to be issued under [paragraph (1)](#i-1) to the [Secretary](/usc/21/802.md?p=24) of Health and Human Services. In issuing an order under [paragraph (1)](#i-1), the Attorney General shall take into consideration any comments submitted by the [Secretary](/usc/21/802.md?p=24) in response to a notice transmitted pursuant to this paragraph. - (4) A temporary scheduling order issued under [paragraph (1)](#i-1) shall be vacated upon the issuance of a permanent scheduling order under [paragraph (6)](#i-6). - (5) An order issued under [paragraph (1)](#i-1) is not subject to judicial review. - (6) The Attorney General may, by rule, issue a permanent order adding a [drug](/usc/21/321.md?p=g-1) or other substance to the definition of [anabolic steroids](/usc/21/802.md?p=41-A) if such [drug](/usc/21/321.md?p=g-1) or other substance satisfies the criteria for being considered an [anabolic steroid](/usc/21/802.md?p=41-A) under [section 802(41) of this title](/usc/21/802.md?p=41). Such rulemaking may be commenced simultaneously with the issuance of the temporary order issued under [paragraph (1)](#i-1). - (j) **Interim final rule; date of issuance; procedure for final rule—** - (1) With respect to a [drug](/usc/21/321.md?p=g-1) referred to in [subsection (f)](#f), if the [Secretary](/usc/21/802.md?p=24) of Health and Human Services recommends that the Attorney General [control](/usc/21/802.md?p=5) the [drug](/usc/21/321.md?p=g-1) in schedule II, III, IV, or V pursuant to subsections [(a)](#a) and [(b)](#b), the Attorney General shall, not later than 90 days after the date described in [paragraph (2)](#j-2), issue an interim final rule controlling the [drug](/usc/21/321.md?p=g-1) in accordance with such subsections and [section 812(b) of this title](/usc/21/812.md?p=b) using the procedures described in [paragraph (3)](#j-3). - (2) The date described in this paragraph shall be the later of— - (A) the date on which the Attorney General receives the scientific and medical evaluation and the scheduling recommendation from the [Secretary](/usc/21/802.md?p=24) of Health and Human Services in accordance with [subsection (b)](#b); or - (B) the date on which the Attorney General receives notification from the [Secretary](/usc/21/802.md?p=24) of Health and Human Services that the [Secretary](/usc/21/802.md?p=24) has approved an application under section 505(c), 512, or 571 of the Federal [Food](/usc/21/346a.md?p=a-1), [Drug](/usc/21/321.md?p=g-1), and Cosmetic Act [[21 U.S.C. 355(c)](/usc/21/355.md?p=c), 360b, 360ccc] or [section 262(a) of title 42](/usc/42/262.md?p=a), or indexed a [drug](/usc/21/321.md?p=g-1) under section 572 of the Federal [Food](/usc/21/346a.md?p=a-1), [Drug](/usc/21/321.md?p=g-1), and Cosmetic Act [[21 U.S.C. 360ccc–1](/usc/21/360ccc–1.md)], with respect to the [drug](/usc/21/321.md?p=g-1) described in [paragraph (1)](#j-1). - (3) A rule issued by the Attorney General under [paragraph (1)](#j-1) shall become immediately effective as an interim final rule without requiring the Attorney General to demonstrate good cause therefor. The interim final rule shall give interested [persons](/usc/21/379j–21.md?p=k-10) the opportunity to comment and to request a hearing. After the conclusion of such proceedings, the Attorney General shall issue a final rule in accordance with the scheduling criteria of subsections [(b)](#b), [(c)](#c), and [(d)](#d) of this section and [section 812(b) of this title](/usc/21/812.md?p=b). # §812. Schedules of controlled substances - (a) **Establishment—** There are established five schedules of [controlled substances](/usc/21/802.md?p=6), to be known as schedules I, II, III, IV, and V. Such schedules shall initially consist of the substances listed in this section. The schedules established by this section shall be updated and republished on a semiannual basis during the two-year period beginning one year after October 27, 1970, and shall be updated and republished on an annual basis thereafter.[^1] - (b) **Placement on schedules; findings required—** Except where [control](/usc/21/802.md?p=5) is required by [United States](/usc/21/802.md?p=28) obligations under an international treaty, convention, or protocol, in effect on October 27, 1970, and except in the case of an [immediate precursor](/usc/21/802.md?p=23), a [drug](/usc/21/321.md?p=g-1) or other substance may not be placed in any schedule unless the findings required for such schedule are made with respect to such [drug](/usc/21/321.md?p=g-1) or other substance. The findings required for each of the schedules are as follows: - (1) **Schedule I.—** - (A) The [drug](/usc/21/321.md?p=g-1) or other substance has a high potential for abuse. - (B) The [drug](/usc/21/321.md?p=g-1) or other substance has no currently accepted medical use in treatment in the [United States](/usc/21/802.md?p=28). - (C) There is a lack of accepted safety for use of the [drug](/usc/21/321.md?p=g-1) or other substance under medical supervision. - (2) **Schedule II.—** - (A) The [drug](/usc/21/321.md?p=g-1) or other substance has a high potential for abuse. - (B) The [drug](/usc/21/321.md?p=g-1) or other substance has a currently accepted medical use in treatment in the [United States](/usc/21/802.md?p=28) or a currently accepted medical use with severe restrictions. - (C) Abuse of the [drug](/usc/21/321.md?p=g-1) or other substances may lead to severe psychological or physical dependence. - (3) **Schedule III.—** - (A) The [drug](/usc/21/321.md?p=g-1) or other substance has a potential for abuse less than the [drugs](/usc/21/321.md?p=g-1) or other substances in schedules I and II. - (B) The [drug](/usc/21/321.md?p=g-1) or other substance has a currently accepted medical use in treatment in the [United States](/usc/21/802.md?p=28). - (C) Abuse of the [drug](/usc/21/321.md?p=g-1) or other substance may lead to moderate or low physical dependence or high psychological dependence. - (4) **Schedule IV.—** - (A) The [drug](/usc/21/321.md?p=g-1) or other substance has a low potential for abuse relative to the [drugs](/usc/21/321.md?p=g-1) or other substances in schedule III. - (B) The [drug](/usc/21/321.md?p=g-1) or other substance has a currently accepted medical use in treatment in the [United States](/usc/21/802.md?p=28). - (C) Abuse of the [drug](/usc/21/321.md?p=g-1) or other substance may lead to limited physical dependence or psychological dependence relative to the [drugs](/usc/21/321.md?p=g-1) or other substances in schedule III. - (5) **Schedule V.—** - (A) The [drug](/usc/21/321.md?p=g-1) or other substance has a low potential for abuse relative to the [drugs](/usc/21/321.md?p=g-1) or other substances in schedule IV. - (B) The [drug](/usc/21/321.md?p=g-1) or other substance has a currently accepted medical use in treatment in the [United States](/usc/21/802.md?p=28). - (C) Abuse of the [drug](/usc/21/321.md?p=g-1) or other substance may lead to limited physical dependence or psychological dependence relative to the [drugs](/usc/21/321.md?p=g-1) or other substances in schedule IV. - (c) **Initial schedules of controlled substances—** Schedules I, II, III, IV, and V shall, unless and until amended pursuant to [section 811 of this title](/usc/21/811.md), consist of the following [drugs](/usc/21/321.md?p=g-1) or other substances,[^1] by whatever official name, common or usual name, chemical name, or brand name designated: Schedule I - (a) Unless specifically excepted or unless listed in another schedule, any of the following [opiates](/usc/21/802.md?p=18), including their [isomers](/usc/21/802.md?p=14), esters, ethers, salts, and salts of [isomers](/usc/21/802.md?p=14), esters, and ethers, whenever the existence of such [isomers](/usc/21/802.md?p=14), esters, ethers, and salts is possible within the specific chemical designation: - (1) Acetylmethadol. - (2) Allylprodine. - (3) Alphacetylmathadol.[^2] - (4) Alphameprodine. - (5) Alphamethadol. - (6) Benzethidine. - (7) Betacetylmethadol. - (8) Betameprodine. - (9) Betamethadol. - (10) Betaprodine. - (11) Clonitazene. - (12) Dextromoramide. - (13) Dextrorphan. - (14) Diampromide. - (15) Diethylthiambutene. - (16) Dimenoxadol. - (17) Dimepheptanol. - (18) Dimethylthiambutene. - (19) Dioxaphetyl butyrate. - (20) Dipipanone. - (21) Ethylmethylthiambutene. - (22) Etonitazene. - (23) Etoxeridine. - (24) Furethidine. - (25) Hydroxypethidine. - (26) Ketobemidone. - (27) Levomoramide. - (28) Levophenacylmorphan. - (29) Morpheridine. - (30) Noracymethadol. - (31) Norlevorphanol. - (32) Normethadone. - (33) Norpipanone. - (34) Phenadoxone. - (35) Phenampromide. - (36) Phenomorphan. - (37) Phenoperidine. - (38) Piritramide. - (39) Proheptazine. - (40) Properidine. - (41) Racemoramide. - (42) Trimeperidine. - (b) Unless specifically excepted or unless listed in another schedule, any of the following opium derivatives, their salts, [isomers](/usc/21/802.md?p=14), and salts of [isomers](/usc/21/802.md?p=14) whenever the existence of such salts, [isomers](/usc/21/802.md?p=14), and salts of [isomers](/usc/21/802.md?p=14) is possible within the specific chemical designation: - (1) Acetorphine. - (2) Acetyldihydrocodeine. - (3) Benzylmorphine. - (4) Codeine methylbromide. - (5) Codeine-N-Oxide. - (6) Cyprenorphine. - (7) Desomorphine. - (8) Dihydromorphine. - (9) Etorphine. - (10) Heroin. - (11) Hydromorphinol. - (12) Methyldesorphine. - (13) Methylhydromorphine. - (14) Morphine methylbromide. - (15) Morphine methylsulfonate. - (16) Morphine-N-Oxide. - (17) Myrophine. - (18) Nicocodeine. - (19) Nicomorphine. - (20) Normorphine. - (21) Pholcodine. - (22) Thebacon. - (c) Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation, which contains any quantity of the following hallucinogenic substances, or which contains any of their salts, [isomers](/usc/21/802.md?p=14), and salts of [isomers](/usc/21/802.md?p=14) whenever the existence of such salts, [isomers](/usc/21/802.md?p=14), and salts of [isomers](/usc/21/802.md?p=14) is possible within the specific chemical designation: - (1) 3,4-methylenedioxy amphetamine. - (2) 5-methoxy-3,4-methylenedioxy amphetamine. - (3) 3,4,5-trimethoxy amphetamine. - (4) Bufotenine. - (5) Diethyltryptamine. - (6) Dimethyltryptamine. - (7) 4-methyl-2,5-dimethoxyamphetamine. - (8) Ibogaine. - (9) Lysergic acid diethylamide. - (10) [Marihuana](/usc/21/802.md?p=16-A). - (11) Mescaline. - (12) Peyote. - (13) N-ethyl-3-piperidyl benzilate. - (14) N-methyl-3-piperidyl benzilate. - (15) Psilocybin. - (16) Psilocyn. - (17) Tetrahydrocannabinols, except for tetrahydrocannabinols in hemp (as defined under [section 1639o](/usc/7/1639o.md) of title 7). - (18) 4-methylmethcathinone (Mephedrone). - (19) 3,4-methylenedioxypyrovalerone (MDPV). - (20) 2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C–E). - (21) 2-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C–D). - (22) 2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C–C). - (23) 2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C–I). - (24) 2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine (2C–T–2). - (25) 2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine (2C–T–4). - (26) 2-(2,5-Dimethoxyphenyl)ethanamine (2C–H). - (27) 2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C–N). - (28) 2-(2,5-Dimethoxy-4-(n)-propylphenyl)ethanamine (2C–P). - (d) - (1) Unless specifically exempted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of [cannabimimetic agents](#d-2-A), or which contains their salts, [isomers](/usc/21/802.md?p=14), and salts of [isomers](/usc/21/802.md?p=14) whenever the existence of such salts, [isomers](/usc/21/802.md?p=14), and salts of [isomers](/usc/21/802.md?p=14) is possible within the specific chemical designation. - (2) In [paragraph (1)](#d-1): - (A) The term “cannabimimetic agents” means any substance that is a cannabinoid receptor type 1 (CB1 receptor) agonist as demonstrated by binding studies and functional assays within any of the following structural classes: - (i) 2-(3-hydroxycyclohexyl)phenol with substitution at the 5-position of the phenolic ring by alkyl or alkenyl, whether or not substituted on the cyclohexyl ring to any extent. - (ii) 3-(1-naphthoyl)indole or 3-(1-naphthylmethane)indole by substitution at the nitrogen atom of the indole ring, whether or not further substituted on the indole ring to any extent, whether or not substituted on the naphthoyl or naphthyl ring to any extent. - (iii) 3-(1-naphthoyl)pyrrole by substitution at the nitrogen atom of the pyrrole ring, whether or not further substituted in the pyrrole ring to any extent, whether or not substituted on the naphthoyl ring to any extent. - (iv) 1-(1-naphthylmethylene)indene by substitution of the 3-position of the indene ring, whether or not further substituted in the indene ring to any extent, whether or not substituted on the naphthyl ring to any extent. - (v) 3-phenylacetylindole or 3-benzoylindole by substitution at the nitrogen atom of the indole ring, whether or not further substituted in the indole ring to any extent, whether or not substituted on the phenyl ring to any extent. - (B) Such term includes— - (i) 5-(1,1-dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol (CP–47,497); - (ii) 5-(1,1-dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol (cannabicyclohexanol or CP–47,497 C8-homolog); - (iii) 1-pentyl-3-(1-naphthoyl)indole (JWH–018 and AM678); - (iv) 1-butyl-3-(1-naphthoyl)indole (JWH–073); - (v) 1-hexyl-3-(1-naphthoyl)indole (JWH–019); - (vi) 1-[2-(4-morpholinyl)ethyl]-3-(1-naphthoyl)indole (JWH–200); - (vii) 1-pentyl-3-(2-methoxyphenylacetyl)indole (JWH–250); - (viii) 1-pentyl-3-[1-(4-methoxynaphthoyl)]indole (JWH–081); - (ix) 1-pentyl-3-(4-methyl-1-naphthoyl)indole (JWH–122); - (x) 1-pentyl-3-(4-chloro-1-naphthoyl)indole (JWH–398); - (xi) 1-(5-fluoropentyl)-3-(1-naphthoyl)indole (AM2201); - (xii) 1-(5-fluoropentyl)-3-(2-iodobenzoyl)indole (AM694); - (xiii) 1-pentyl-3-[(4-methoxy)-benzoyl]indole (SR–19 and RCS–4); - (xiv) 1-cyclohexylethyl-3-(2-methoxyphenylacetyl)indole (SR–18 and RCS–8); and - (xv) 1-pentyl-3-(2-chlorophenylacetyl)indole (JWH–203). - (e) - (1) Unless specifically exempted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of a [fentanyl-related substance](#e-2), or which contains the salts, [isomers](/usc/21/802.md?p=14), and salts of [isomers](/usc/21/802.md?p=14) of a [fentanyl-related substance](#e-2) whenever the existence of such salts, [isomers](/usc/21/802.md?p=14), and salts of [isomers](/usc/21/802.md?p=14) is possible within the specific chemical designation. - (2) For purposes of [paragraph (1)](#e-1), except as provided in [paragraph (3)](#e-3), the term “fentanyl-related substance” means any substance that is structurally related to fentanyl by 1 or more of the following modifications: - (A) By replacement of the phenyl portion of the phenethyl group by any monocycle, whether or not further substituted in or on the monocycle. - (B) By substitution in or on the phenethyl group with alkyl, alkenyl, alkoxyl, hydroxyl, halo, haloalkyl, amino, or nitro groups. - (C) By substitution in or on the piperidine ring with alkyl, alkenyl, alkoxyl, ester, ether, hydroxyl, halo, haloalkyl, amino, or nitro groups. - (D) By replacement of the aniline ring with any aromatic monocycle whether or not further substituted in or on the aromatic monocycle. - (E) By replacement of the N-propionyl group with another acyl group. - (3) A substance that satisfies the definition of the term “[fentanyl-related substance](#e-2)” in [paragraph (2)](#e-2) shall nonetheless not be treated as a [fentanyl-related substance](#e-2) subject to this schedule if the substance— - (A) is controlled by action of the Attorney General under [section 811 of this title](/usc/21/811.md); or - (B) is otherwise expressly listed in a schedule other than this schedule. - (4) - (A) The Attorney General may by order publish in the Federal Register a list of substances that satisfy the definition of the term “[fentanyl-related substance](#e-2)” in [paragraph (2)](#e-2). - (B) The absence of a substance from a list published under [subparagraph (A)](#e-4-A) does not negate the [control](/usc/21/802.md?p=5) status of the substance under this schedule if the substance satisfies the definition of the term “[fentanyl-related substance](#e-2)” in [paragraph (2)](#e-2). Schedule II - (a) Unless specifically excepted or unless listed in another schedule, any of the following substances whether produced directly or indirectly by extraction from substances of vegetable origin, or independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis: - (1) Opium and [opiate](/usc/21/802.md?p=18), and any salt, compound, derivative, or preparation of opium or [opiate](/usc/21/802.md?p=18). - (2) Any salt, compound, derivative, or preparation thereof which is chemically equivalent or identical with any of the substances referred to in [clause (1)](#a-1), except that these substances shall not include the isoquinoline alkaloids of opium. - (3) [Opium poppy](/usc/21/802.md?p=19) and [poppy straw](/usc/21/802.md?p=20). - (4) coca[^3] leaves, except coca leaves and extracts of coca leaves from which cocaine, ecgonine, and derivatives of ecgonine or their salts have been removed; cocaine, its salts, optical and geometric [isomers](/usc/21/802.md?p=14), and salts of [isomers](/usc/21/802.md?p=14); ecgonine, its derivatives, their salts, [isomers](/usc/21/802.md?p=14), and salts of [isomers](/usc/21/802.md?p=14); or any compound, mixture, or preparation which contains any quantity of any of the substances referred to in this paragraph. - (b) Unless specifically excepted or unless listed in another schedule, any of the following [opiates](/usc/21/802.md?p=18), including their [isomers](/usc/21/802.md?p=14), esters, ethers, salts, and salts of [isomers](/usc/21/802.md?p=14), esters and ethers, whenever the existence of such [isomers](/usc/21/802.md?p=14), esters, ethers, and salts is possible within the specific chemical designation: - (1) Alphaprodine. - (2) Anileridine. - (3) Bezitramide. - (4) Dihydrocodeine. - (5) Diphenoxylate. - (6) Fentanyl. - (7) Isomethadone. - (8) Levomethorphan. - (9) Levorphanol. - (10) Metazocine. - (11) Methadone. - (12) Methadone-Intermediate, 4-cyano-2-dimethylamino-4,4-diphenyl butane. - (13) Moramide-Intermediate, 2-methyl-3-morpholino-1, 1-diphenylpropane-carboxylic acid. - (14) Pethidine. - (15) Pethidine-Intermediate-A, 4-cyano-1-methyl-4-phenylpiperidine. - (16) Pethidine-Intermediate-B, ethyl-4-phenylpiperidine-4-carboxylate. - (17) Pethidine-Intermediate-C, 1-methyl-4-phenylpiperidine-4-carboxylic acid. - (18) Phenazocine. - (19) Piminodine. - (20) Racemethorphan. - (21) Racemorphan. - (c) Unless specifically excepted or unless listed in another schedule, any injectable liquid which contains any quantity of methamphetamine, including its salts, [isomers](/usc/21/802.md?p=14), and salts of [isomers](/usc/21/802.md?p=14). Schedule III - (a) Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances having a stimulant effect on the central nervous system: - (1) Amphetamine, its salts, optical [isomers](/usc/21/802.md?p=14), and salts of its optical [isomers](/usc/21/802.md?p=14). - (2) Phenmetrazine and its salts. - (3) Any substance (except an injectable liquid) which contains any quantity of methamphetamine, including its salts, [isomers](/usc/21/802.md?p=14), and salts of [isomers](/usc/21/802.md?p=14). - (4) Methylphenidate. - (b) Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances having a depressant effect on the central nervous system: - (1) Any substance which contains any quantity of a derivative of barbituric acid, or any salt of a derivative of barbituric acid. - (2) Chorhexadol.[^4] - (3) Glutethimide. - (4) Lysergic acid. - (5) Lysergic acid amide. - (6) Methyprylon. - (7) Phencyclidine. - (8) Sulfondiethylmethane. - (9) Sulfonethylmethane. - (10) Sulfonmethane. - (c) Nalorphine. - (d) Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation containing limited quantities of any of the following [narcotic drugs](/usc/21/802.md?p=17), or any salts thereof: - (1) Not more than 1.8 grams of codeine per 100 milliliters or not more than 90 milligrams per dosage unit, with an equal or greater quantity of an isoquinoline alkaloid of opium. - (2) Not more than 1.8 grams of codeine per 100 milliliters or not more than 90 milligrams per dosage unit, with one or more active, non-narcotic ingredients in recognized therapeutic amounts. - (3) Not more than 300 milligrams of dihydrocodeinone per 100 milliliters or not more than 15 milligrams per dosage unit, with a fourfold or greater quantity of an isoquinoline alkaloid of opium. - (4) Not more than 300 milligrams of dihydrocodeinone per 100 milliliters or not more than 15 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts. - (5) Not more than 1.8 grams of dihydrocodeine per 100 milliliters or not more than 90 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts. - (6) Not more than 300 milligrams of ethylmorphine per 100 milliliters or not more than 15 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts. - (7) Not more than 500 milligrams of opium per 100 milliliters or per 100 grams, or not more than 25 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts. - (8) Not more than 50 milligrams of morphine per 100 milliliters or per 100 grams with one or more active, nonnarcotic ingredients in recognized therapeutic amounts. - (e) [Anabolic steroids](/usc/21/802.md?p=41-A). - (1) Barbital. - (2) Chloral betaine. - (3) Chloral hydrate. - (4) Ethchlorvynol. - (5) Ethinamate. - (6) Methohexital. - (7) Meprobamate. - (8) Methylphenobarbital. - (9) Paraldehyde. - (10) Petrichloral. - (11) Phenobarbital. Schedule V Any compound, mixture, or preparation containing any of the following limited quantities of [narcotic drugs](/usc/21/802.md?p=17), which shall include one or more nonnarcotic active medicinal ingredients in sufficient proportion to confer upon the compound, mixture, or preparation valuable medicinal qualities other than those possessed by the [narcotic drug](/usc/21/802.md?p=17) alone: Schedule IV # §813. Treatment of controlled substance analogues - (a) **In general—** A [controlled substance analogue](/usc/21/802.md?p=32-A) shall, to the extent intended for human consumption, be treated, for the purposes of any Federal law as a [controlled substance](/usc/21/802.md?p=6) in schedule I. - (b) **Determination—** In determining whether a [controlled substance analogue](/usc/21/802.md?p=32-A) was intended for human consumption under [subsection (a)](#a), the following factors may be considered, along with any other relevant factors: - (1) The marketing, advertising, and labeling of the substance. - (2) The known efficacy or usefulness of the substance for the marketed, advertised, or labeled purpose. - (3) The difference between the price at which the substance is sold and the price at which the substance it is purported to be or advertised as is normally sold. - (4) The diversion of the substance from legitimate channels and the clandestine importation, [manufacture](/usc/21/802.md?p=15), or [distribution](/usc/21/360eee.md?p=5) of the substance. - (5) Whether the defendant knew or should have known the substance was intended to be consumed by injection, inhalation, ingestion, or any other immediate means. - (6) Any [controlled substance analogue](/usc/21/802.md?p=32-A) that is manufactured, formulated, sold, distributed, or marketed with the intent to avoid the provisions of existing [drug](/usc/21/321.md?p=g-1) laws. - (c) **Limitation—** For purposes of this section, evidence that a substance was not marketed, advertised, or labeled for human consumption, by itself, shall not be sufficient to establish that the substance was not intended for human consumption. # §814. Removal of exemption of certain drugs - (a) **Removal of exemption—** The Attorney General shall by regulation remove from exemption under [section 802(39)(A)(iv) of this title](/usc/21/802.md?p=39-A-iv) a [drug](/usc/21/321.md?p=g-1) or group of [drugs](/usc/21/321.md?p=g-1) that the Attorney General finds is being diverted to obtain a [listed chemical](/usc/21/802.md?p=33) for use in the illicit [production](/usc/21/802.md?p=22) of a [controlled substance](/usc/21/802.md?p=6). - (b) **Factors to be considered—** In removing a [drug](/usc/21/321.md?p=g-1) or group of [drugs](/usc/21/321.md?p=g-1) from exemption under [subsection (a)](#a), the Attorney General shall consider, with respect to a [drug](/usc/21/321.md?p=g-1) or group of [drugs](/usc/21/321.md?p=g-1) that is proposed to be removed from exemption— - (1) the scope, duration, and significance of the diversion; - (2) whether the [drug](/usc/21/321.md?p=g-1) or group of [drugs](/usc/21/321.md?p=g-1) is formulated in such a way that it cannot be easily used in the illicit [production](/usc/21/802.md?p=22) of a [controlled substance](/usc/21/802.md?p=6); and - (3) whether the [listed chemical](/usc/21/802.md?p=33) can be readily recovered from the [drug](/usc/21/321.md?p=g-1) or group of [drugs](/usc/21/321.md?p=g-1). - (c) **Specificity of designation—** The Attorney General shall limit the designation of a [drug](/usc/21/321.md?p=g-1) or a group of [drugs](/usc/21/321.md?p=g-1) removed from exemption under [subsection (a)](#a) to the most particularly identifiable type of [drug](/usc/21/321.md?p=g-1) or group of [drugs](/usc/21/321.md?p=g-1) for which evidence of diversion exists unless there is evidence, based on the pattern of diversion and other relevant factors, that the diversion will not be limited to that particular [drug](/usc/21/321.md?p=g-1) or group of [drugs](/usc/21/321.md?p=g-1). - (d) **Reinstatement of exemption with respect to particular drug products—** - (1) **Reinstatement—** On application by a [manufacturer](/usc/21/802.md?p=15) of a particular [drug product](/usc/21/321.md?p=dd) that has been removed from exemption under [subsection (a)](#a), the Attorney General shall by regulation reinstate the exemption with respect to that particular [drug product](/usc/21/321.md?p=dd) if the Attorney General determines that the particular [drug product](/usc/21/321.md?p=dd) is manufactured and distributed in a manner that prevents diversion. - (2) **Factors to be considered—** In deciding whether to reinstate the exemption with respect to a particular [drug product](/usc/21/321.md?p=dd) under [paragraph (1)](#d-1), the Attorney General shall consider— - (A) the package sizes and manner of packaging of the [drug product](/usc/21/321.md?p=dd); - (B) the manner of [distribution](/usc/21/360eee.md?p=5) and advertising of the [drug product](/usc/21/321.md?p=dd); - (C) evidence of diversion of the [drug product](/usc/21/321.md?p=dd); - (D) any actions taken by the [manufacturer](/usc/21/802.md?p=15) to prevent diversion of the [drug product](/usc/21/321.md?p=dd); and - (E) such other factors as are relevant to and consistent with the public health and safety, including the factors described in [subsection (b)](#b) as applied to the [drug product](/usc/21/321.md?p=dd). - (3) **Status pending application for reinstatement—** A transaction involving a particular [drug product](/usc/21/321.md?p=dd) that is the subject of a bona fide pending application for reinstatement of exemption filed with the Attorney General not later than 60 days after a regulation removing the exemption is issued pursuant to [subsection (a)](#a) shall not be considered to be a [regulated transaction](/usc/21/802.md?p=39) if the transaction occurs during the pendency of the application and, if the Attorney General denies the application, during the period of 60 days following the date on which the Attorney General denies the application, unless— - (A) the Attorney General has evidence that, applying the factors described in [subsection (b)](#b) to the [drug product](/usc/21/321.md?p=dd), the [drug product](/usc/21/321.md?p=dd) is being diverted; and - (B) the Attorney General so notifies the applicant. - (4) **Amendment and modification—** A regulation reinstating an exemption under [paragraph (1)](#d-1) may be modified or revoked with respect to a particular [drug product](/usc/21/321.md?p=dd) upon a finding that— - (A) applying the factors described in [subsection (b)](#b) to the [drug product](/usc/21/321.md?p=dd), the [drug product](/usc/21/321.md?p=dd) is being diverted; or - (B) there is a significant change in the data that led to the issuance of the regulation. # §821. Rules and regulations The Attorney General is [authorized](/usc/21/360eee–1.md?p=a-6) to promulgate rules and regulations and to charge reasonable fees relating to the registration and [control](/usc/21/802.md?p=5) of the [manufacture](/usc/21/802.md?p=15), [distribution](/usc/21/360eee.md?p=5), and dispensing of [controlled substances](/usc/21/802.md?p=6) and to [listed chemicals](/usc/21/802.md?p=33). # §822. Persons required to register - (a) **Period of registration—** - (1) Every [person](/usc/21/379j–21.md?p=k-10) who [manufactures](/usc/21/802.md?p=15) or [distributes](/usc/21/802.md?p=11) any [controlled substance](/usc/21/802.md?p=6) or [list I chemical](/usc/21/802.md?p=34), or who proposes to engage in the [manufacture](/usc/21/802.md?p=15) or [distribution](/usc/21/360eee.md?p=5) of any [controlled substance](/usc/21/802.md?p=6) or [list I chemical](/usc/21/802.md?p=34), shall obtain annually a registration issued by the Attorney General in accordance with the rules and regulations promulgated by him. - (2) Every [person](/usc/21/379j–21.md?p=k-10) who [dispenses](/usc/21/802.md?p=10), or who proposes to [dispense](/usc/21/802.md?p=10), any [controlled substance](/usc/21/802.md?p=6), shall obtain from the Attorney General a registration issued in accordance with the rules and regulations promulgated by him. The Attorney General shall, by regulation, determine the period of such registrations. In no event, however, shall such registrations be issued for less than one year nor for more than three years. - (3) - (A) Except as provided in [subparagraph (C)](#a-3-C), the registration of any registrant under this subchapter to [manufacture](/usc/21/802.md?p=15), [distribute](/usc/21/802.md?p=11), or [dispense](/usc/21/802.md?p=10) [controlled substances](/usc/21/802.md?p=6) or [list I chemicals](/usc/21/802.md?p=34) terminates if and when such registrant— - (i) dies; - (ii) ceases legal existence; - (iii) discontinues business or professional practice; or - (iv) surrenders such registration. - (B) In the case of such a registrant who ceases legal existence or discontinues business or professional practice, such registrant shall promptly notify the Attorney General in writing of such fact. - (C) No registration under this subchapter to [manufacture](/usc/21/802.md?p=15), [distribute](/usc/21/802.md?p=11), or [dispense](/usc/21/802.md?p=10) [controlled substances](/usc/21/802.md?p=6) or [list I chemicals](/usc/21/802.md?p=34), and no authority conferred thereby, may be assigned or otherwise transferred except upon such conditions as the Attorney General may specify and then only pursuant to written consent. A registrant to whom a registration is assigned or transferred pursuant to the preceding sentence may not [manufacture](/usc/21/802.md?p=15), [distribute](/usc/21/802.md?p=11), or [dispense](/usc/21/802.md?p=10) [controlled substances](/usc/21/802.md?p=6) or [list I chemicals](/usc/21/802.md?p=34) pursuant to such registration until the Attorney General receives such written consent. - (D) In the case of a registrant under this subchapter to [manufacture](/usc/21/802.md?p=15), [distribute](/usc/21/802.md?p=11), or [dispense](/usc/21/802.md?p=10) [controlled substances](/usc/21/802.md?p=6) or [list I chemicals](/usc/21/802.md?p=34) desiring to discontinue business or professional practice altogether or with respect to [controlled substances](/usc/21/802.md?p=6) and [list I chemicals](/usc/21/802.md?p=34) (without assigning or transferring such business or professional practice to another entity), such registrant shall return to the Attorney General for cancellation— - (i) the registrant’s certificate of registration; - (ii) any unexecuted order forms in the registrant’s possession; and - (iii) any other documentation that the Attorney General may require. - (b) **Authorized activities—** [Persons](/usc/21/379j–21.md?p=k-10) registered by the Attorney General under this subchapter to [manufacture](/usc/21/802.md?p=15), [distribute](/usc/21/802.md?p=11), or [dispense](/usc/21/802.md?p=10) [controlled substances](/usc/21/802.md?p=6) or [list I chemicals](/usc/21/802.md?p=34) are [authorized](/usc/21/360eee–1.md?p=a-6) to possess, [manufacture](/usc/21/802.md?p=15), [distribute](/usc/21/802.md?p=11), or [dispense](/usc/21/802.md?p=10) such substances or chemicals (including any such activity in the conduct of research) to the extent [authorized](/usc/21/360eee–1.md?p=a-6) by their registration and in conformity with the other provisions of this subchapter. - (c) **Exceptions—** The following [persons](/usc/21/379j–21.md?p=k-10) shall not be required to register and may lawfully possess any [controlled substance](/usc/21/802.md?p=6) or [list I chemical](/usc/21/802.md?p=34) under this subchapter: - (1) An [agent](/usc/21/802.md?p=3) or employee of any registered [manufacturer](/usc/21/802.md?p=15), [distributor](/usc/21/802.md?p=11), or [dispenser](/usc/21/802.md?p=10) of any [controlled substance](/usc/21/802.md?p=6) or [list I chemical](/usc/21/802.md?p=34) if such [agent](/usc/21/802.md?p=3) or employee is acting in the usual course of his business or employment. - (2) A common or contract carrier or warehouseman, or an employee thereof, whose possession of the [controlled substance](/usc/21/802.md?p=6) or [list I chemical](/usc/21/802.md?p=34) is in the usual course of his business or employment. - (3) An [ultimate user](/usc/21/802.md?p=27) who possesses such substance for a purpose specified in [section 802(27) of this title](/usc/21/802.md?p=27). - (4) An [agent](/usc/21/802.md?p=3) or employee of a research institution that is conducting research with a [controlled substance](/usc/21/802.md?p=6) if— - (A) the [agent](/usc/21/802.md?p=3) or employee is acting within the scope of the professional practice of the [agent](/usc/21/802.md?p=3) or employee; - (B) another [agent](/usc/21/802.md?p=3) or employee of the institution is registered to conduct research with a [controlled substance](/usc/21/802.md?p=6) in the same schedule; - (C) the researcher who is so registered— - (i) informs the Attorney General of the name, position title, and employing institution of the [agent](/usc/21/802.md?p=3) or employee who is not separately registered; - (ii) authorizes that [agent](/usc/21/802.md?p=3) or employee to perform research under the registration of the registered researcher; and - (iii) affirms that any act taken by that [agent](/usc/21/802.md?p=3) or employee involving a [controlled substance](/usc/21/802.md?p=6) shall be attributable to the registered researcher, as if the researcher had directly committed the act, for purposes of any proceeding under [section 824(a) of this title](/usc/21/824.md?p=a) to suspend or revoke the registration of the registered researcher; and - (D) the Attorney General does not, within 30 days of receiving the information, authorization, and affirmation described in [subparagraph (C)](#c-4-C), refuse, for a reason listed in [section 824(a) of this title](/usc/21/824.md?p=a), to allow the [agent](/usc/21/802.md?p=3) or employee to possess the substance without a separate registration. - (d) **Waiver—** The Attorney General may, by regulation, waive the requirement for registration of certain [manufacturers](/usc/21/802.md?p=15), [distributors](/usc/21/802.md?p=11), or [dispensers](/usc/21/802.md?p=10) if he finds it consistent with the public health and safety. - (e) **Separate registration—** - (1) A separate registration shall be required at each principal place of business or professional practice where the applicant [manufactures](/usc/21/802.md?p=15), [distributes](/usc/21/802.md?p=11), or [dispenses](/usc/21/802.md?p=10) [controlled substances](/usc/21/802.md?p=6) or [list I chemicals](/usc/21/802.md?p=34). - (2) Notwithstanding [paragraph (1)](#e-1), a registrant who is a veterinarian shall not be required to have a separate registration in order to transport and [dispense](/usc/21/802.md?p=10) [controlled substances](/usc/21/802.md?p=6) in the usual course of veterinary practice at a site other than the registrant’s registered principal place of business or professional practice, so long as the site of transporting and dispensing is located in a [State](/usc/21/802.md?p=26) where the veterinarian is [licensed](/usc/21/360eee–1.md?p=a-6) to practice veterinary medicine and is not a principal place of business or professional practice. - (3) Notwithstanding [paragraph (1)](#e-1), a registrant that is dispensing pursuant to [section 823(h) of this title](/usc/21/823.md?p=h) [narcotic drugs](/usc/21/802.md?p=17) to individuals for [maintenance treatment](/usc/21/802.md?p=29) or [detoxification treatment](/usc/21/802.md?p=30) shall not be required to have a separate registration to incorporate one or more mobile medication units into the registrant’s practice to [dispense](/usc/21/802.md?p=10) such narcotics at locations other than the registrant’s principal place of business or professional practice described in [paragraph (1)](#e-1), so long as the registrant meets such standards for operation of a mobile medication unit as the Attorney General may establish. - (4) - (A) Notwithstanding [paragraph (1)](#e-1), a [person](/usc/21/379j–21.md?p=k-10) registered to conduct research with a [controlled substance](/usc/21/802.md?p=6) under [section 823(g) of this title](/usc/21/823.md?p=g) may conduct the research under a single registration if— - (i) the research occurs exclusively on sites all of which are— - (I) within the same city or county; and - (II) under the [control](/usc/21/802.md?p=5) of the same institution, organization, or agency; and - (ii) before commencing the research, the researcher notifies the Attorney General of each site where— - (I) the research will be conducted; or - (II) the [controlled substance](/usc/21/802.md?p=6) will be stored or administered. - (B) A site described in [subparagraph (A)](#e-4-A) shall be included in a registration described in that subparagraph only if the researcher has notified the Attorney General of the site— - (i) in the application for the registration; or - (ii) before the research is conducted, or before the [controlled substance](/usc/21/802.md?p=6) is stored or administered, at the site. - (C) The Attorney General may, in consultation with the [Secretary](/usc/21/802.md?p=24), issue regulations addressing, with respect to research sites described in [subparagraph (A)](#e-4-A)— - (i) the manner in which [controlled substances](/usc/21/802.md?p=6) may be delivered to the research sites; - (ii) the storage and security of [controlled substances](/usc/21/802.md?p=6) at the research sites; - (iii) the maintenance of records for the research sites; and - (iv) any other matters necessary to ensure effective [controls](/usc/21/802.md?p=5) against diversion at the research sites. - (f) **Inspection—** - (1) The Attorney General is [authorized](/usc/21/360eee–1.md?p=a-6) to inspect the establishment of a registrant or applicant for registration in accordance with the rules and regulations promulgated by him. - (2) - (A) If a [person](/usc/21/379j–21.md?p=k-10) is registered to conduct research with a [controlled substance](/usc/21/802.md?p=6) and applies for a registration, or for a modification of a registration, to conduct research with a second [controlled substance](/usc/21/802.md?p=6) that is in the same schedule as the first [controlled substance](/usc/21/802.md?p=6), or is in a schedule with a higher numerical designation than the schedule of the first [controlled substance](/usc/21/802.md?p=6), a new inspection by the Attorney General of the registered location is not required. - (B) Nothing in [subparagraph (A)](#f-2-A) shall prohibit the Attorney General from conducting an inspection that the Attorney General determines necessary to ensure that a registrant maintains effective [controls](/usc/21/802.md?p=5) against diversion. - (g) **Delivery of controlled substances by ultimate users for disposal—** - (1) An [ultimate user](/usc/21/802.md?p=27) who has lawfully obtained a [controlled substance](/usc/21/802.md?p=6) in accordance with this subchapter may, without being registered, [deliver](/usc/21/802.md?p=8) the [controlled substance](/usc/21/802.md?p=6) to another [person](/usc/21/379j–21.md?p=k-10) for the purpose of disposal of the [controlled substance](/usc/21/802.md?p=6) if— - (A) the [person](/usc/21/379j–21.md?p=k-10) receiving the [controlled substance](/usc/21/802.md?p=6) is [authorized](/usc/21/360eee–1.md?p=a-6) under this subchapter to engage in such activity; and - (B) the disposal takes place in accordance with regulations issued by the Attorney General to prevent diversion of [controlled substances](/usc/21/802.md?p=6). - (2) In developing regulations under this subsection, the Attorney General shall take into consideration the public health and safety, as well as the ease and cost of [program](/usc/21/1523.md?p=8) implementation and participation by various communities. Such regulations may not require any entity to establish or operate a [delivery](/usc/21/802.md?p=8) or disposal [program](/usc/21/1523.md?p=8). - (3) The Attorney General may, by regulation, authorize long-term care [facilities](/usc/21/350g.md?p=o-2), as defined by the Attorney General by regulation, to dispose of [controlled substances](/usc/21/802.md?p=6) on behalf of [ultimate users](/usc/21/802.md?p=27) who reside, or have resided, at such long-term care [facilities](/usc/21/350g.md?p=o-2) in a manner that the Attorney General determines will provide effective [controls](/usc/21/802.md?p=5) against diversion and be consistent with the public health and safety. - (4) If a [person](/usc/21/379j–21.md?p=k-10) dies while lawfully in possession of a [controlled substance](/usc/21/802.md?p=6) for personal use, any [person](/usc/21/379j–21.md?p=k-10) lawfully entitled to dispose of the decedent’s property may [deliver](/usc/21/802.md?p=8) the [controlled substance](/usc/21/802.md?p=6) to another [person](/usc/21/379j–21.md?p=k-10) for the purpose of disposal under the same conditions as provided in [paragraph (1)](#g-1) for an [ultimate user](/usc/21/802.md?p=27). - (5) - (A) In the case of a [person](/usc/21/379j–21.md?p=k-10) receiving [hospice care](#g-5-B-i), an [employee of a qualified hospice program](#g-5-B-ii), acting within the scope of employment, may handle, without being registered under this section, any [controlled substance](/usc/21/802.md?p=6) that was lawfully dispensed to the [person](/usc/21/379j–21.md?p=k-10) receiving [hospice care](#g-5-B-i), for the purpose of disposal of the [controlled substance](/usc/21/802.md?p=6) so long as such disposal occurs onsite in accordance with all applicable Federal, [State](/usc/21/802.md?p=26), Tribal, and local law and— - (i) the disposal occurs after the death of a [person](/usc/21/379j–21.md?p=k-10) receiving [hospice care](#g-5-B-i); - (ii) the [controlled substance](/usc/21/802.md?p=6) is expired; or - (iii) - (I) the employee is— - (aa) the physician of the [person](/usc/21/379j–21.md?p=k-10) receiving [hospice care](#g-5-B-i); and - (bb) registered under [section 823(g) of this title](/usc/21/823.md?p=g); and - (II) the hospice patient no longer requires the [controlled substance](/usc/21/802.md?p=6) because the plan of care of the hospice patient has been modified. - (B) For the purposes of this paragraph: - (i) The terms “hospice care” and “hospice program” have the meanings given to those terms in [section 1395x(dd) of title 42](/usc/42/1395x.md?p=dd). - (ii) The term “employee of a qualified hospice program” means a physician, physician assistant, nurse, or other [person](/usc/21/379j–21.md?p=k-10) who— - (I) is employed by, or pursuant to arrangements made by, a [qualified hospice program](#g-5-B-iii); - (II) - (aa) is [licensed](/usc/21/360eee–1.md?p=a-6) to perform medical or nursing services by the jurisdiction in which the [person](/usc/21/379j–21.md?p=k-10) receiving [hospice care](#g-5-B-i) was located; and - (bb) is acting within the scope of such employment in accordance with applicable [State](/usc/21/802.md?p=26) law; and - (III) has completed training through the [qualified hospice program](#g-5-B-iii) regarding the disposal of [controlled substances](/usc/21/802.md?p=6) in a secure and responsible manner so as to discourage abuse, misuse, or diversion. - (iii) The term “qualified hospice program” means a [hospice program](#g-5-B-i) that— - (I) has written policies and procedures for assisting in the disposal of the [controlled substances](/usc/21/802.md?p=6) of a [person](/usc/21/379j–21.md?p=k-10) receiving [hospice care](#g-5-B-i) after the [person](/usc/21/379j–21.md?p=k-10)’s death; - (II) at the time when the [controlled substances](/usc/21/802.md?p=6) are first ordered— - (aa) provides a copy of the written policies and procedures to the patient or patient representative and family; - (bb) discusses the policies and procedures with the patient or representative and the family in a language and manner that they understand to ensure that these parties are educated regarding the safe disposal of [controlled substances](/usc/21/802.md?p=6); and - (cc) documents in the patient’s clinical record that the written policies and procedures were provided and discussed; and - (III) at the time following the disposal of the [controlled substances](/usc/21/802.md?p=6)— - (aa) documents in the patient’s clinical record the type of [controlled substance](/usc/21/802.md?p=6), dosage, route of administration, and quantity so disposed; and - (bb) the time, date, and manner in which that disposal occurred. - (h) **Continuation of research on substances newly added to schedule I—** If a [person](/usc/21/379j–21.md?p=k-10) is conducting research on a substance when the substance is added to schedule I, and the [person](/usc/21/379j–21.md?p=k-10) is already registered to conduct research with a [controlled substance](/usc/21/802.md?p=6) in schedule I— - (1) not later than 90 days after the scheduling of the newly scheduled substance, the [person](/usc/21/379j–21.md?p=k-10) shall submit a completed application for registration or modification of existing registration, to conduct research on the substance, in accordance with regulations issued by the Attorney General for purposes of this paragraph; - (2) the [person](/usc/21/379j–21.md?p=k-10) may, notwithstanding subsections [(a)](#a) and [(b)](#b), continue to conduct the research on the substance until— - (A) the [person](/usc/21/379j–21.md?p=k-10) withdraws the application described in paragraph (1) of this subsection; or - (B) the Attorney General serves on the [person](/usc/21/379j–21.md?p=k-10) an order to show cause proposing the denial of the application under [section 824(c) of this title](/usc/21/824.md?p=c); - (3) if the Attorney General serves an order to show cause as described in [paragraph (2)(B)](#h-2-B) and the [person](/usc/21/379j–21.md?p=k-10) requests a hearing, the hearing shall be held on an expedited basis and not later than 45 days after the request is made, except that the hearing may be held at a later time if so requested by the [person](/usc/21/379j–21.md?p=k-10); and - (4) if the [person](/usc/21/379j–21.md?p=k-10) sends a copy of the application described in [paragraph (1)](#h-1) to a [manufacturer](/usc/21/802.md?p=15) or [distributor](/usc/21/802.md?p=11) of the substance, receipt of the copy by the [manufacturer](/usc/21/802.md?p=15) or [distributor](/usc/21/802.md?p=11) shall constitute sufficient evidence that the [person](/usc/21/379j–21.md?p=k-10) is [authorized](/usc/21/360eee–1.md?p=a-6) to receive the substance. - (i) **Treatment of certain manufacturing activities as coincident to research—** - (1) **In general—** Except as provided in [paragraph (3)](#i-3), a [person](/usc/21/379j–21.md?p=k-10) who is registered to perform research on a [controlled substance](/usc/21/802.md?p=6) may perform manufacturing activities with small quantities of that substance, including activities described in [paragraph (2)](#i-2), without being required to obtain a manufacturing registration, if— - (A) the activities are performed for the purpose of the research; and - (B) the activities and the quantities of the substance involved in the activities are stated in— - (i) a notification submitted to the Attorney General under [section 823(n) of this title](/usc/21/823.md?p=n); - (ii) a research protocol filed with an application for registration approval under [section 823(g) of this title](/usc/21/823.md?p=g); or - (iii) a notification to the Attorney General that includes— - (I) the name of the registrant; and - (II) an attestation that the research to be conducted with the small quantities of manufactured substance is consistent with the scope of the research that is the basis for the registration. - (2) **Activities included—** Activities permitted under [paragraph (1)](#i-1) include— - (A) processing the substance to create extracts, tinctures, oils, solutions, derivatives, or other forms of the substance consistent with— - (i) the information provided as part of a notification submitted to the Attorney General under [section 823(n) of this title](/usc/21/823.md?p=n); or - (ii) a research protocol filed with an application for registration approval under [section 823(g) of this title](/usc/21/823.md?p=g); and - (B) dosage form development studies performed for the purpose of requesting an investigational new [drug](/usc/21/321.md?p=g-1) exemption under [section 355(i) of this title](/usc/21/355.md?p=i). - (3) **Exception regarding marihuana—** The authority under [paragraph (1)](#i-1) to [manufacture](/usc/21/802.md?p=15) substances does not include the authority to grow [marihuana](/usc/21/802.md?p=16-A). # §822a. Prescription drug take back expansion - (a) **Definition of covered entity—** In this section, the term “covered entity” means— - (1) a [State](/usc/21/802.md?p=26), local, or tribal law enforcement agency; - (2) a [manufacturer](/usc/21/802.md?p=15), [distributor](/usc/21/802.md?p=11), or reverse [distributor](/usc/21/802.md?p=11) of prescription medications; - (3) a retail pharmacy; - (4) a registered narcotic treatment [program](/usc/21/1523.md?p=8); - (5) a hospital or clinic with an onsite pharmacy; - (6) an eligible long-term care [facility](/usc/21/350g.md?p=o-2); or - (7) any other entity [authorized](/usc/21/360eee–1.md?p=a-6) by the [Drug Enforcement Administration](/usc/21/802.md?p=4) to dispose of prescription medications. - (b) **Program authorized—** The Attorney General, in coordination with the [Administrator](/usc/21/1523.md?p=1) of the [Drug Enforcement Administration](/usc/21/802.md?p=4), the [Secretary](/usc/21/802.md?p=24) of Health and Human Services, and the Director of the [Office](/usc/21/1701.md?p=14) of National [Drug](/usc/21/321.md?p=g-1) [Control](/usc/21/802.md?p=5) Policy, shall coordinate with [covered entities](#a) in expanding or making available disposal sites for unwanted prescription medications. # §823. Registration requirements - (a) **Manufacturers of controlled substances in schedule I or II—** The Attorney General shall register an applicant to [manufacture](/usc/21/802.md?p=15) [controlled substances](/usc/21/802.md?p=6) in schedule I or II if he determines that such registration is consistent with the public interest and with [United States](/usc/21/802.md?p=28) obligations under international treaties, conventions, or protocols in effect on May 1, 1971. In determining the public interest, the following factors shall be considered: - (1) maintenance of effective [controls](/usc/21/802.md?p=5) against diversion of particular [controlled substances](/usc/21/802.md?p=6) and any [controlled substance](/usc/21/802.md?p=6) in schedule I or II compounded therefrom into other than legitimate medical, scientific, research, or industrial channels, by limiting the importation and bulk [manufacture](/usc/21/802.md?p=15) of such [controlled substances](/usc/21/802.md?p=6) to a number of establishments which can produce an adequate and uninterrupted supply of these substances under adequately competitive conditions for legitimate medical, scientific, research, and industrial purposes; - (2) compliance with applicable [State](/usc/21/802.md?p=26) and local law; - (3) promotion of technical advances in the art of manufacturing these substances and the development of new substances; - (4) prior conviction record of applicant under Federal and [State](/usc/21/802.md?p=26) laws relating to the [manufacture](/usc/21/802.md?p=15), [distribution](/usc/21/360eee.md?p=5), or dispensing of such substances; - (5) past experience in the [manufacture](/usc/21/802.md?p=15) of [controlled substances](/usc/21/802.md?p=6), and the existence in the establishment of effective [control](/usc/21/802.md?p=5) against diversion; and - (6) such other factors as may be relevant to and consistent with the public health and safety. - (b) **Distributors of controlled substances in schedule I or II—** The Attorney General shall register an applicant to [distribute](/usc/21/802.md?p=11) a [controlled substance](/usc/21/802.md?p=6) in schedule I or II unless he determines that the issuance of such registration is inconsistent with the public interest. In determining the public interest, the following factors shall be considered: - (1) maintenance of effective [control](/usc/21/802.md?p=5) against diversion of particular [controlled substances](/usc/21/802.md?p=6) into other than legitimate medical, scientific, and industrial channels; - (2) compliance with applicable [State](/usc/21/802.md?p=26) and local law; - (3) prior conviction record of applicant under Federal or [State](/usc/21/802.md?p=26) laws relating to the [manufacture](/usc/21/802.md?p=15), [distribution](/usc/21/360eee.md?p=5), or dispensing of such substances; - (4) past experience in the [distribution](/usc/21/360eee.md?p=5) of [controlled substances](/usc/21/802.md?p=6); and - (5) such other factors as may be relevant to and consistent with the public health and safety. - (c) **Manufacturers of marijuana for research purposes—** - (1) - (A) As it relates to applications to [manufacture](/usc/21/802.md?p=15) [marijuana](/usc/21/802.md?p=16-A) for research purposes, when the Attorney General places a notice in the Federal Register to increase the number of entities registered under this chapter to [manufacture](/usc/21/802.md?p=15) [marijuana](/usc/21/802.md?p=16-A) to supply appropriately registered researchers in the [United States](/usc/21/802.md?p=28), the Attorney General shall, not later than 60 days after the date on which the Attorney General receives a completed application— - (i) approve the application; or - (ii) request supplemental information. - (B) For purposes of [subparagraph (A)](#c-1-A), an application shall be deemed complete when the applicant has submitted documentation showing each of the following: - (i) The requirements designated in the notice in the Federal Register are satisfied. - (ii) The requirements under this chapter are satisfied. - (iii) The applicant will limit the transfer and sale of any [marijuana](/usc/21/802.md?p=16-A) manufactured under this subsection— - (I) to researchers who are registered under this chapter to conduct research with [controlled substances](/usc/21/802.md?p=6) in schedule I; and - (II) for purposes of use in preclinical research or in a clinical investigation pursuant to an investigational new [drug](/usc/21/321.md?p=g-1) exemption under 355(i)[^1] of this title. - (iv) The applicant will transfer or sell any [marijuana](/usc/21/802.md?p=16-A) manufactured under this subsection only with prior, written consent for the transfer or sale by the Attorney General. - (v) The applicant has completed the application and review process under [subsection (a)](#a) for the bulk [manufacture](/usc/21/802.md?p=15) of [controlled substances](/usc/21/802.md?p=6) in schedule I. - (vi) The applicant has established and begun operation of a process for storage and handling of [controlled substances](/usc/21/802.md?p=6) in schedule I, including for inventory [control](/usc/21/802.md?p=5) and monitoring security in accordance with section 105 of the Medical [Marijuana](/usc/21/802.md?p=16-A) and Cannabidiol Research Expansion Act. - (vii) The applicant is [licensed](/usc/21/360eee–1.md?p=a-6) by each [State](/usc/21/802.md?p=26) in which the applicant will conduct operations under this subsection, to [manufacture](/usc/21/802.md?p=15) [marijuana](/usc/21/802.md?p=16-A), if that [State](/usc/21/802.md?p=26) requires such a license. - (C) Not later than 30 days after the date on which the Attorney General receives supplemental information requested under [subparagraph (A)(ii)](#c-1-A-ii) with respect to an application, the Attorney General shall approve or deny the application. - (2) If an application described in this subsection is denied, the Attorney General shall provide a written explanation of the basis of denial to the applicant. - (d) **Limits of authorized activities—** Registration granted under subsections [(a)](#a) and [(b)](#b) of this section shall not entitle a registrant to (1) [manufacture](/usc/21/802.md?p=15) or [distribute](/usc/21/802.md?p=11) [controlled substances](/usc/21/802.md?p=6) in schedule I or II other than those specified in the registration, or (2) [manufacture](/usc/21/802.md?p=15) any quantity of those [controlled substances](/usc/21/802.md?p=6) in excess of the quota assigned pursuant to [section 826 of this title](/usc/21/826.md). - (e) **Manufacturers of controlled substances in schedule III, IV, or V—** The Attorney General shall register an applicant to [manufacture](/usc/21/802.md?p=15) [controlled substances](/usc/21/802.md?p=6) in schedule III, IV, or V, unless he determines that the issuance of such registration is inconsistent with the public interest. In determining the public interest, the following factors shall be considered: - (1) maintenance of effective [controls](/usc/21/802.md?p=5) against diversion of particular [controlled substances](/usc/21/802.md?p=6) and any [controlled substance](/usc/21/802.md?p=6) in schedule III, IV, or V compounded therefrom into other than legitimate medical, scientific, or industrial channels; - (2) compliance with applicable [State](/usc/21/802.md?p=26) and local law; - (3) promotion of technical advances in the art of manufacturing these substances and the development of new substances; - (4) prior conviction record of applicant under Federal or [State](/usc/21/802.md?p=26) laws relating to the [manufacture](/usc/21/802.md?p=15), [distribution](/usc/21/360eee.md?p=5), or dispensing of such substances; - (5) past experience in the [manufacture](/usc/21/802.md?p=15), [distribution](/usc/21/360eee.md?p=5), and dispensing of [controlled substances](/usc/21/802.md?p=6), and the existence in the establishment of effective [controls](/usc/21/802.md?p=5) against diversion; and - (6) such other factors as may be relevant to and consistent with the public health and safety. - (f) **Distributors of controlled substances in schedule III, IV, or V—** The Attorney General shall register an applicant to [distribute](/usc/21/802.md?p=11) [controlled substances](/usc/21/802.md?p=6) in schedule III, IV, or V, unless he determines that the issuance of such registration is inconsistent with the public interest. In determining the public interest, the following factors shall be considered: - (1) maintenance of effective [controls](/usc/21/802.md?p=5) against diversion of particular [controlled substances](/usc/21/802.md?p=6) into other than legitimate medical, scientific, and industrial channels; - (2) compliance with applicable [State](/usc/21/802.md?p=26) and local law; - (3) prior conviction record of applicant under Federal or [State](/usc/21/802.md?p=26) laws relating to the [manufacture](/usc/21/802.md?p=15), [distribution](/usc/21/360eee.md?p=5), or dispensing of such substances; - (4) past experience in the [distribution](/usc/21/360eee.md?p=5) of [controlled substances](/usc/21/802.md?p=6); and - (5) such other factors as may be relevant to and consistent with the public health and safety. - (g) **Research by practitioners; pharmacies; research applications; construction of Article 7 of the Convention on Psychotropic Substances—** - (1) The Attorney General shall register [practitioners](/usc/21/802.md?p=21) (including pharmacies, as distinguished from pharmacists) to [dispense](/usc/21/802.md?p=10), or conduct research with, [controlled substances](/usc/21/802.md?p=6) in schedule II, III, IV, or V and shall modify the registrations of pharmacies so registered to authorize them to [dispense](/usc/21/802.md?p=10) [controlled substances](/usc/21/802.md?p=6) by means of the [Internet](/usc/21/802.md?p=50), if the applicant is [authorized](/usc/21/360eee–1.md?p=a-6) to [dispense](/usc/21/802.md?p=10), or conduct research with respect to, [controlled substances](/usc/21/802.md?p=6) under the laws of the [State](/usc/21/802.md?p=26) in which he practices. The Attorney General may deny an application for such registration or such modification of registration if the Attorney General determines that the issuance of such registration or modification would be inconsistent with the public interest. In determining the public interest, the following factors shall be considered: - (A) The recommendation of the appropriate [State](/usc/21/802.md?p=26) licensing board or professional disciplinary authority. - (B) The applicant’s experience in dispensing, or conducting research with respect to [controlled substances](/usc/21/802.md?p=6). - (C) The applicant’s conviction record under Federal or [State](/usc/21/802.md?p=26) laws relating to the [manufacture](/usc/21/802.md?p=15), [distribution](/usc/21/360eee.md?p=5), or dispensing of [controlled substances](/usc/21/802.md?p=6). - (D) Compliance with applicable [State](/usc/21/802.md?p=26), Federal, or local laws relating to [controlled substances](/usc/21/802.md?p=6). - (E) Such other conduct which may threaten the public health and safety. Separate registration under this part for [practitioners](/usc/21/802.md?p=21) engaging in research with [controlled substances](/usc/21/802.md?p=6) in schedule II, III, IV, or V, who are already registered under this part in another capacity, shall not be required. - (2) - (A) Registration applications by [practitioners](/usc/21/802.md?p=21) wishing to conduct research with [controlled substances](/usc/21/802.md?p=6) in schedule I shall be referred to the [Secretary](/usc/21/802.md?p=24), who shall determine the qualifications and competency of each [practitioner](/usc/21/802.md?p=21) requesting registration, as well as the merits of the research protocol. The [Secretary](/usc/21/802.md?p=24), in determining the merits of each research protocol, shall consult with the Attorney General as to effective procedures to adequately safeguard against diversion of such [controlled substances](/usc/21/802.md?p=6) from legitimate medical or scientific use. Registration for the purpose of bona fide research with [controlled substances](/usc/21/802.md?p=6) in schedule I by a [practitioner](/usc/21/802.md?p=21) deemed qualified by the [Secretary](/usc/21/802.md?p=24) may be denied by the Attorney General only on a ground specified in [section 824(a) of this title](/usc/21/824.md?p=a). - (B) - (i) The Attorney General shall register a [practitioner](/usc/21/802.md?p=21) to conduct research with [marijuana](/usc/21/802.md?p=16-A) (including any derivative, extract, preparation, and compound thereof) if— - (I) the applicant’s research protocol has been reviewed and allowed— - (aa) by the [Secretary](/usc/21/802.md?p=24) of Health and Human Services under [section 355(i) of this title](/usc/21/355.md?p=i); - (bb) by the National Institutes of Health or another Federal agency that funds scientific research; or - (cc) pursuant to sections [1301.18](/cfr/21/1301.18.md) and [1301.32](/cfr/21/1301.32.md) of title 21, Code of Federal Regulations, or any successors thereto; and - (II) the applicant has demonstrated to the Attorney General that there are effective procedures in place to adequately safeguard against diversion of the [controlled substance](/usc/21/802.md?p=6) for legitimate medical or scientific use pursuant to section 105 of the Medical [Marijuana](/usc/21/802.md?p=16-A) and Cannabidiol Research Expansion Act, including demonstrating that the security measures are adequate for storing the quantity of [marijuana](/usc/21/802.md?p=16-A) the applicant would be [authorized](/usc/21/360eee–1.md?p=a-6) to possess. - (ii) The Attorney General may deny an application for registration under this subparagraph only if the Attorney General determines that the issuance of the registration would be inconsistent with the public interest. In determining the public interest, the Attorney General shall consider the factors listed in— - (I) [subparagraphs (B) through (E)](#g-1-B..g-1-E) of paragraph (1); and - (II) [subparagraph (A)](#g-1-A) of paragraph (1), if the applicable [State](/usc/21/802.md?p=26) requires [practitioners](/usc/21/802.md?p=21) conducting research to register with a board or authority described in such [subparagraph (A)](#g-2-A). - (iii) - (I) Not later than 60 days after the date on which the Attorney General receives a complete application for registration under this subparagraph, the Attorney General shall— - (aa) approve the application; or - (bb) request supplemental information. - (II) For purposes of [subclause (I)](#g-2-B-iii-I), an application shall be deemed complete when the applicant has submitted documentation showing that the requirements under [clause (i)](#g-2-B-i) are satisfied. - (iv) Not later than 30 days after the date on which the Attorney General receives supplemental information as described in [clause (iii)(I)(bb)](#g-2-B-iii-I-bb) in connection with an application described in this subparagraph, the Attorney General shall approve or deny the application. - (v) If an application described in this subparagraph is denied, the Attorney General shall provide a written explanation of the basis of denial to the applicant. - (vi) - (I) If the Attorney General grants an application for registration under [clause (i)](#g-2-B-i), the registrant may amend or supplement the research protocol without notification to, or review by, the [Drug Enforcement Administration](/usc/21/802.md?p=4) if the registrant does not change— - (aa) the quantity or type of [marijuana](/usc/21/802.md?p=16-A) or cannabidiol (including any derivative, extract, preparation, and compound thereof); - (bb) the source of such [marijuana](/usc/21/802.md?p=16-A) or cannabidiol; or - (cc) the conditions under which such [marijuana](/usc/21/802.md?p=16-A) or cannabidiol is stored, tracked, or administered. - (II) - (aa) If a registrant under [clause (i)](#g-2-B-i) seeks to change the type of [marijuana](/usc/21/802.md?p=16-A) or cannabidiol (including any derivative, extract, preparation, and compound thereof), the source of such [marijuana](/usc/21/802.md?p=16-A) or cannabidiol, or the conditions under which such [marijuana](/usc/21/802.md?p=16-A) or cannabidiol is stored, tracked, or administered, the registrant shall notify the Attorney General via registered mail, or an electronic means permitted by the Attorney General, not later than 30 days before implementing an amended or supplemental research protocol. - (bb) A registrant may proceed with an amended or supplemental research protocol described in [item (aa)](#g-2-B-vi-II-aa) if the Attorney General does not explicitly object during the 30-day period beginning on the date on which the Attorney General receives the notice under [item (aa)](#g-2-B-vi-II-aa). - (cc) The Attorney General may only object to an amended or supplemental research protocol under this subclause if additional security measures are needed to safeguard against diversion or abuse. - (dd) If a registrant under [clause (i)](#g-2-B-i) seeks to address additional security measures identified by the Attorney General under item (cc), the registrant shall notify the Attorney General via registered mail, or an electronic means permitted by the Attorney General, not later than 30 days before implementing an amended or supplemental research protocol. - (ee) A registrant may proceed with an amended or supplemental research protocol described in item (dd) if the Attorney General does not explicitly object during the 30-day period beginning on the date on which the Attorney General receives the notice under item (dd). - (III) - (aa) If a registrant under [clause (i)](#g-2-B-i) seeks to change the quantity of [marijuana](/usc/21/802.md?p=16-A) needed for research and the change in quantity does not impact the factors described in item [(bb)](#g-2-B-vi-I-bb) or [(cc)](#g-2-B-vi-I-cc) of subclause (I) of this clause, the registrant shall notify the Attorney General via registered mail or using an electronic means permitted by the Attorney General. - (bb) A notification under [item (aa)](#g-2-B-vi-III-aa) shall include— - (AA) the [Drug Enforcement Administration](/usc/21/802.md?p=4) registration number of the registrant; - (BB) the quantity of [marijuana](/usc/21/802.md?p=16-A) or cannabidiol already obtained; - (CC) the quantity of additional [marijuana](/usc/21/802.md?p=16-A) or cannabidiol needed to complete the research; and - (DD) an attestation that the change in quantity does not impact the source of the [marijuana](/usc/21/802.md?p=16-A) or cannabidiol or the conditions under which the [marijuana](/usc/21/802.md?p=16-A) or cannabidiol is stored, tracked, or administered. - (cc) The Attorney General shall ensure that— - (AA) any registered mail return receipt with respect to a notification under [item (aa)](#g-2-B-vi-III-aa) is submitted for [delivery](/usc/21/802.md?p=8) to the registrant providing the notification not later than 3 days after receipt of the notification by the Attorney General; and - (BB) notice of receipt of a notification using an electronic means permitted under [item (aa)](#g-2-B-vi-III-aa) is provided to the registrant providing the notification not later than 3 days after receipt of the notification by the Attorney General. - (dd) - (AA) On and after the date described in subitem (BB), a registrant that submits a notification in accordance with [item (aa)](#g-2-B-vi-III-aa) may proceed with the research as if the change in quantity has been approved on such date, unless the Attorney General notifies the registrant of an objection described in [item (ee)](#g-2-B-vi-III-ee). - (BB) The date described in this subitem is the date on which a registrant submitting a notification under [item (aa)](#g-2-B-vi-III-aa) receives the registered mail return receipt with respect to the notification or the date on which the registrant receives notice that the notification using an electronic means permitted under [item (aa)](#g-2-B-vi-III-aa) was received by the Attorney General, as the case may be. - (ee) A notification submitted under [item (aa)](#g-2-B-vi-III-aa) shall be deemed to be approved unless the Attorney General, not later than 10 days after receiving the notification, explicitly objects based on a finding that the change in quantity— - (AA) does impact the source of the [marijuana](/usc/21/802.md?p=16-A) or cannabidiol or the conditions under which the [marijuana](/usc/21/802.md?p=16-A) or cannabidiol is stored, tracked, or administered; or - (BB) necessitates that the registrant implement additional security measures to safeguard against diversion or abuse. - (IV) Nothing in this clause shall limit the authority of the [Secretary](/usc/21/802.md?p=24) of Health and Human Services over requirements related to research protocols, including changes in— - (aa) the method of administration of [marijuana](/usc/21/802.md?p=16-A) or cannabidiol; - (bb) the dosing of [marijuana](/usc/21/802.md?p=16-A) or cannabidiol; and - (cc) the number of individuals or patients involved in research. - (3) Article 7 of the [Convention on Psychotropic Substances](/usc/21/802.md?p=31) shall not be construed to prohibit, or impose additional restrictions upon, research involving [drugs](/usc/21/321.md?p=g-1) or other substances scheduled under the convention which is conducted in conformity with this subsection and other applicable provisions of this subchapter. - (h) **Practitioners dispensing narcotic drugs for narcotic treatment; annual registration; separate registration; qualifications—** [Practitioners](/usc/21/802.md?p=21) who [dispense](/usc/21/802.md?p=10) [narcotic drugs](/usc/21/802.md?p=17) (other than [narcotic drugs](/usc/21/802.md?p=17) in schedule III, IV, or V) to individuals for [maintenance treatment](/usc/21/802.md?p=29) or [detoxification treatment](/usc/21/802.md?p=30) shall obtain annually a separate registration for that purpose. The Attorney General shall register an applicant to [dispense](/usc/21/802.md?p=10) [narcotic drugs](/usc/21/802.md?p=17) to individuals for [maintenance treatment](/usc/21/802.md?p=29) or [detoxification treatment](/usc/21/802.md?p=30) (or both)— - (1) if the applicant is a [practitioner](/usc/21/802.md?p=21) who is determined by the [Secretary](/usc/21/802.md?p=24) to be qualified (under standards established by the [Secretary](/usc/21/802.md?p=24)) to engage in the treatment with respect to which registration is sought; - (2) if the Attorney General determines that the applicant will comply with standards established by the Attorney General respecting (A) security of stocks of [narcotic drugs](/usc/21/802.md?p=17) for such treatment, and (B) the maintenance of records (in accordance with [section 827 of this title](/usc/21/827.md)) on such [drugs](/usc/21/321.md?p=g-1); and - (3) if the [Secretary](/usc/21/802.md?p=24) determines that the applicant will comply with standards established by the [Secretary](/usc/21/802.md?p=24) (after consultation with the Attorney General) respecting the quantities of [narcotic drugs](/usc/21/802.md?p=17) which may be provided for unsupervised use by individuals in such treatment. - (i) **Applicants for distribution of list I chemicals—** The Attorney General shall register an applicant to [distribute](/usc/21/802.md?p=11) a [list I chemical](/usc/21/802.md?p=34) unless the Attorney General determines that registration of the applicant is inconsistent with the public interest. Registration under this subsection shall not be required for the [distribution](/usc/21/360eee.md?p=5) of a [drug product](/usc/21/321.md?p=dd) that is exempted under clause (iv) or (v) of [section 802(39)(A) of this title](/usc/21/802.md?p=39-A). In determining the public interest for the purposes of this subsection, the Attorney General shall consider— - (1) maintenance by the applicant of effective [controls](/usc/21/802.md?p=5) against diversion of [listed chemicals](/usc/21/802.md?p=33) into other than legitimate channels; - (2) compliance by the applicant with applicable Federal, [State](/usc/21/802.md?p=26), and local law; - (3) any prior conviction record of the applicant under Federal or [State](/usc/21/802.md?p=26) laws relating to [controlled substances](/usc/21/802.md?p=6) or to chemicals controlled under Federal or [State](/usc/21/802.md?p=26) law; - (4) any past experience of the applicant in the [manufacture](/usc/21/802.md?p=15) and [distribution](/usc/21/360eee.md?p=5) of chemicals; and - (5) such other factors as are relevant to and consistent with the public health and safety. - (j) **Registration to manufacture certain controlled substances for use only in a clinical trial—** - (1) For purposes of registration to [manufacture](/usc/21/802.md?p=15) a [controlled substance](/usc/21/802.md?p=6) under [subsection (e)](#e) for use only in a clinical trial, the Attorney General shall register the applicant, or serve an order to show cause upon the applicant in accordance with [section 824(c) of this title](/usc/21/824.md?p=c), not later than 180 days after the date on which the application is accepted for filing. - (2) For purposes of registration to [manufacture](/usc/21/802.md?p=15) a [controlled substance](/usc/21/802.md?p=6) under [subsection (a)](#a) for use only in a clinical trial, the Attorney General shall, in accordance with the regulations issued by the Attorney General, issue a notice of application not later than 90 days after the application is accepted for filing. Not later than 90 days after the date on which the period for comment pursuant to such notice ends, the Attorney General shall register the applicant, or serve an order to show cause upon the applicant in accordance with [section 824(c) of this title](/usc/21/824.md?p=c), unless the Attorney General has granted a hearing on the application under [section 958(i) of this title](/usc/21/958.md?p=i). - (k) **Emergency medical services that administer controlled substances—** - (1) **Registration—** For the purpose of enabling [emergency medical services professionals](#k-13-E) to [administer](/usc/21/802.md?p=2) [controlled substances](/usc/21/802.md?p=6) in schedule II, III, IV, or V to [ultimate users](/usc/21/802.md?p=27) receiving [emergency medical services](#k-13-C) in accordance with the requirements of this subsection, the Attorney General— - (A) shall register an [emergency medical services agency](#k-13-D) if the agency submits an application demonstrating it is [authorized](/usc/21/360eee–1.md?p=a-6) to conduct such activity under the laws of each [State](/usc/21/802.md?p=26) in which the agency practices; and - (B) may deny an application for such registration if the Attorney General determines that the issuance of such registration would be inconsistent with the requirements of this subsection or the public interest based on the factors listed in [subsection (g)](#g). - (2) **Option for single registration—** In registering an [emergency medical services agency](#k-13-D) pursuant to [paragraph (1)](#k-1), the Attorney General shall allow such agency the option of a single registration in each [State](/usc/21/802.md?p=26) where the agency [administers](/usc/21/802.md?p=2) [controlled substances](/usc/21/802.md?p=6) in lieu of requiring a separate registration for each location of the [emergency medical services agency](#k-13-D). - (3) **Hospital-based agency—** If a [hospital-based](#k-13-G) [emergency medical services agency](#k-13-D) is registered under [subsection (g)](#g), the agency may use the registration of the hospital to [administer](/usc/21/802.md?p=2) [controlled substances](/usc/21/802.md?p=6) in accordance with this subsection without being registered under this subsection. - (4) **Administration outside physical presence of medical director or authorizing medical professional—** [Emergency medical services professionals](#k-13-E) of a [registered emergency medical services agency](#k-13-J) may [administer](/usc/21/802.md?p=2) [controlled substances](/usc/21/802.md?p=6) in schedule II, III, IV, or V outside the physical presence of a [medical director](#k-13-H) or [authorizing medical professional](#k-13-A) in the course of providing [emergency medical services](#k-13-C) if the administration is— - (A) [authorized](/usc/21/360eee–1.md?p=a-6) by the law of the [State](/usc/21/802.md?p=26) in which it occurs; and - (B) pursuant to— - (i) a [standing order](#k-13-M) that is issued and adopted by one or more [medical directors](#k-13-H) of the agency, including any such order that may be developed by a [specific State authority](#k-13-L); or - (ii) a [verbal order](#k-13-N) that is— - (I) issued in accordance with a policy of the agency; and - (II) provided by a [medical director](#k-13-H) or [authorizing medical professional](#k-13-A) in response to a request by the [emergency medical services professional](#k-13-E) with respect to a specific patient— - (aa) in the case of a mass casualty incident; or - (bb) to ensure the proper care and treatment of a specific patient. - (5) **Delivery—** A [registered emergency medical services agency](#k-13-J) may [deliver](/usc/21/802.md?p=8) [controlled substances](/usc/21/802.md?p=6) from a [registered location](#k-13-K) of the agency to an unregistered location of the agency only if the agency— - (A) designates the unregistered location for such [delivery](/usc/21/802.md?p=8); and - (B) notifies the Attorney General at least 30 days prior to first delivering [controlled substances](/usc/21/802.md?p=6) to the unregistered location. - (6) **Storage—** A [registered emergency medical services agency](#k-13-J) may store [controlled substances](/usc/21/802.md?p=6)— - (A) at a [registered location](#k-13-K) of the agency; - (B) at any [designated location](#k-13-B) of the agency or in an emergency services vehicle situated at a registered or [designated location](#k-13-B) of the agency; or - (C) in an [emergency medical services vehicle](#k-13-F) used by the agency that is— - (i) traveling from, or returning to, a registered or [designated location](#k-13-B) of the agency in the course of responding to an emergency; or - (ii) otherwise actively in use by the agency under circumstances that provide for security of the [controlled substances](/usc/21/802.md?p=6) consistent with the requirements established by regulations of the Attorney General. - (7) **No treatment as distribution—** The [delivery](/usc/21/802.md?p=8) of [controlled substances](/usc/21/802.md?p=6) by a [registered emergency medical services agency](#k-13-J) pursuant to this subsection shall not be treated as [distribution](/usc/21/360eee.md?p=5) for purposes of [section 828 of this title](/usc/21/828.md). - (8) **Restocking of emergency medical services vehicles at a hospital—** Notwithstanding [paragraph (13)(J)](#k-13-J), a [registered emergency medical services agency](#k-13-J) may receive [controlled substances](/usc/21/802.md?p=6) from a hospital for purposes of restocking an [emergency medical services vehicle](#k-13-F) following an emergency response, and without being subject to the requirements of [section 828 of this title](/usc/21/828.md), provided all of the following conditions are satisfied: - (A) The registered or [designated location](#k-13-B) of the agency where the vehicle is primarily situated maintains a record of such receipt in accordance with [paragraph (9)](#k-9). - (B) The hospital maintains a record of such [delivery](/usc/21/802.md?p=8) to the agency in accordance with [section 827 of this title](/usc/21/827.md). - (C) If the vehicle is primarily situated at a [designated location](#k-13-B), such location notifies the [registered location](#k-13-K) of the agency within 72 hours of the vehicle receiving the [controlled substances](/usc/21/802.md?p=6). - (9) **Maintenance of records—** - (A) **In general—** A [registered emergency medical services agency](#k-13-J) shall maintain records in accordance with subsections (a) and (b) of [section 827 of this title](/usc/21/827.md) of all [controlled substances](/usc/21/802.md?p=6) that are received, administered, or otherwise disposed of pursuant to the agency’s registration, without regard to sub[section 827(c)(1)(B) of this title](/usc/21/827.md?p=c-1-B). - (B) **Requirements—** Such records— - (i) shall include records of [deliveries](/usc/21/802.md?p=8) of [controlled substances](/usc/21/802.md?p=6) between all locations of the agency; and - (ii) shall be maintained, whether electronically or otherwise, at each registered and [designated location](#k-13-B) of the agency where the [controlled substances](/usc/21/802.md?p=6) involved are received, administered, or otherwise disposed of. - (10) **Other requirements—** A [registered emergency medical services agency](#k-13-J), under the supervision of a [medical director](#k-13-H), shall be responsible for ensuring that— - (A) all [emergency medical services professionals](#k-13-E) who [administer](/usc/21/802.md?p=2) [controlled substances](/usc/21/802.md?p=6) using the agency’s registration act in accordance with the requirements of this subsection; - (B) the recordkeeping requirements of [paragraph (9)](#k-9) are met with respect to a [registered location](#k-13-K) and each [designated location](#k-13-B) of the agency; - (C) the applicable physical security requirements established by regulation of the Attorney General are complied with wherever [controlled substances](/usc/21/802.md?p=6) are stored by the agency in accordance with [paragraph (6)](#k-6); and - (D) the agency maintains, at a [registered location](#k-13-K) of the agency, a record of the [standing orders](#k-13-M) issued or adopted in accordance with [paragraph (9)](#k-9). - (11) **Regulations—** The Attorney General may issue regulations— - (A) specifying, with regard to [delivery](/usc/21/802.md?p=8) of [controlled substances](/usc/21/802.md?p=6) under [paragraph (5)](#k-5)— - (i) the types of locations that may be designated under such paragraph; and - (ii) the manner in which a notification under [paragraph (5)(B)](#k-5-B) must be made; - (B) specifying, with regard to the storage of [controlled substances](/usc/21/802.md?p=6) under [paragraph (6)](#k-6), the manner in which such substances must be stored at registered and [designated locations](#k-13-B), including in emergency medical service vehicles; and - (C) addressing the ability of hospitals, [emergency medical services agencies](#k-13-D), [registered locations](#k-13-K), and [designated locations](#k-13-B) to [deliver](/usc/21/802.md?p=8) [controlled substances](/usc/21/802.md?p=6) to each other in the event of— - (i) shortages of such substances; - (ii) a public health emergency; or - (iii) a mass casualty event. - (12) **Rule of construction—** Nothing in this subsection shall be construed— - (A) to limit the authority vested in the Attorney General by other provisions of this subchapter to take measures to prevent diversion of [controlled substances](/usc/21/802.md?p=6); or - (B) to override the authority of any [State](/usc/21/802.md?p=26) to regulate the provision of [emergency medical services](#k-13-C) consistent with this subsection. - (13) **Definitions—** In this section: - (A) The term “authorizing medical professional” means an emergency or other physician, or another medical professional (including an advanced practice registered nurse or physician assistant)— - (i) who is registered under this chapter; - (ii) who is acting within the scope of the registration; and - (iii) whose scope of practice under a [State](/usc/21/802.md?p=26) license or certification includes the ability to provide [verbal orders](#k-13-N). - (B) The term “designated location” means a location designated by an [emergency medical services agency](#k-13-D) under [paragraph (5)](#k-5). - (C) The term “emergency medical services” means emergency medical response and emergency mobile medical services provided outside of a fixed medical [facility](/usc/21/350g.md?p=o-2). - (D) The term “emergency medical services agency” means an organization providing [emergency medical services](#k-13-C), including such an organization that— - (i) is governmental (including fire-based and [hospital-based](#k-13-G) agencies), nongovernmental (including [hospital-based](#k-13-G) agencies), private, or volunteer-based; - (ii) provides [emergency medical services](#k-13-C) by ground, air, or otherwise; and - (iii) is [authorized](/usc/21/360eee–1.md?p=a-6) by the [State](/usc/21/802.md?p=26) in which the organization is providing such services to provide emergency medical care, including the administering of [controlled substances](/usc/21/802.md?p=6), to members of the general public on an emergency basis. - (E) The term “emergency medical services professional” means a health care professional (including a nurse, paramedic, or emergency medical technician) [licensed](/usc/21/360eee–1.md?p=a-6) or certified by the [State](/usc/21/802.md?p=26) in which the professional practices and credentialed by a [medical director](#k-13-H) of the respective [emergency medical services agency](#k-13-D) to provide [emergency medical services](#k-13-C) within the scope of the professional’s [State](/usc/21/802.md?p=26) license or certification. - (F) The term “emergency medical services vehicle” means an ambulance, fire apparatus, supervisor truck, or other vehicle used by an [emergency medical services agency](#k-13-D) for the purpose of providing or facilitating emergency medical care and transport or transporting [controlled substances](/usc/21/802.md?p=6) to and from the registered and [designated locations](#k-13-B). - (G) The term “hospital-based” means, with respect to an agency, owned or operated by a hospital. - (H) The term “medical director” means a physician who is registered under [subsection (g)](#g) and provides [medical oversight](#k-13-I) for an [emergency medical services agency](#k-13-D). - (I) The term “medical oversight” means supervision of the provision of medical care by an [emergency medical services agency](#k-13-D). - (J) The term “registered emergency medical services agency” means— - (i) an [emergency medical services agency](#k-13-D) that is registered pursuant to this subsection; or - (ii) a [hospital-based](#k-13-G) [emergency medical services agency](#k-13-D) that is covered by the registration of the hospital under [subsection (g)](#g). - (K) The term “registered location” means a location that appears on the certificate of registration issued to an [emergency medical services agency](#k-13-D) under this subsection or [subsection (g)](#g), which shall be where the agency receives [controlled substances](/usc/21/802.md?p=6) from [distributors](/usc/21/802.md?p=11). - (L) The term “specific State authority” means a governmental agency or other such authority, including a regional oversight and coordinating body, that, pursuant to [State](/usc/21/802.md?p=26) law or regulation, develops clinical protocols regarding the [delivery](/usc/21/802.md?p=8) of [emergency medical services](#k-13-C) in the geographic jurisdiction of such agency or authority within the [State](/usc/21/802.md?p=26) that may be adopted by [medical directors](#k-13-H). - (M) The term “standing order” means a written medical protocol in which a [medical director](#k-13-H) determines in advance the medical criteria that must be met before administering [controlled substances](/usc/21/802.md?p=6) to individuals in need of [emergency medical services](#k-13-C). - (N) The term “verbal order” means an oral directive that is given through any method of communication including by radio or telephone, directly to an [emergency medical services professional](#k-13-E), to contemporaneously [administer](/usc/21/802.md?p=2) a [controlled substance](/usc/21/802.md?p=6) to individuals in need of [emergency medical services](#k-13-C) outside the physical presence of the [medical director](#k-13-H) or [authorizing medical professional](#k-13-A). - (l) **“Factors as may be relevant to and consistent with the public health and safety” defined—** In this section, the phrase “factors as may be relevant to and consistent with the public health and safety” means factors that are relevant to and consistent with the findings contained in [section 801 of this title](/usc/21/801.md). - (m) **Required training for prescribers—** - (1) **Training required—** As a condition on registration under this section to [dispense](/usc/21/802.md?p=10) [controlled substances](/usc/21/802.md?p=6) in schedule II, III, IV, or V, the Attorney General shall require any [qualified practitioner](#m-4-B), beginning with the [first applicable registration](#m-4-A) for the [practitioner](/usc/21/802.md?p=21), to meet the following: - (A) If the [practitioner](/usc/21/802.md?p=21) is a physician (as defined under [section 1395x(r) of title 42](/usc/42/1395x.md?p=r)) and the [practitioner](/usc/21/802.md?p=21) meets one or more of the following conditions: - (i) The physician holds a board certification in addiction psychiatry or addiction medicine from the American Board of Medical Specialties. - (ii) The physician holds a board certification from the American Board of Addiction Medicine. - (iii) The physician holds a board certification in addiction medicine from the American Osteopathic Association. - (iv) The physician has, with respect to the treatment and management of patients with [opioid](/usc/21/802.md?p=18) or other substance use disorders, or the safe pharmacological management of dental pain and screening, brief intervention, and referral for appropriate treatment of patients with or at risk of developing [opioid](/usc/21/802.md?p=18) or other substance use disorders, completed not less than 8 hours of training (through classroom situations, seminars at professional society meetings, electronic communications, or otherwise) that is provided by— - (I) the American Society of Addiction Medicine, the American Academy of Addiction Psychiatry, the American Medical Association, the American Osteopathic Association, the American Dental Association, the American Association of Oral and Maxillofacial Surgeons, the American Psychiatric Association, the American Academy of Family Physicians, the American Podiatric Medical Association, the Academy of General Dentistry, the American Optometric Association, or any other organization accredited by the Accreditation [Council](/usc/21/2011.md?p=1) for Continuing Medical Education (ACCME), the Commission for Continuing Education Provider Recognition (CCEPR), or the [Council](/usc/21/2011.md?p=1) on Podiatric Medical Education; - (II) any organization accredited by a [State](/usc/21/802.md?p=26) medical society accreditor that is recognized by the ACCME or the CCEPR; - (III) any organization accredited by the American Osteopathic Association or the American Academy of Family Physicians to provide continuing medical education; or - (IV) any organization approved by the Assistant [Secretary](/usc/21/802.md?p=24) for Mental Health and Substance Use, the ACCME, or the CCEPR. - (v) The physician graduated in good standing from an accredited school of allopathic medicine, osteopathic medicine, podiatric medicine, dental surgery, or dental medicine in the [United States](/usc/21/802.md?p=28) during the 5-year period immediately preceding the date on which the physician first registers or renews under this section and has successfully completed a comprehensive allopathic or osteopathic medicine curriculum or accredited medical residency or dental surgery or dental or podiatric medicine curriculum that included not less than 8 hours of training on— - (I) treating and managing patients with [opioid](/usc/21/802.md?p=18) or other substance use disorders, including the appropriate clinical use of all [drugs](/usc/21/321.md?p=g-1) approved by the [Food](/usc/21/346a.md?p=a-1) and [Drug](/usc/21/321.md?p=g-1) Administration for the treatment of a substance use disorder; or - (II) the safe pharmacological management of dental pain and screening, brief intervention, and referral for appropriate treatment of patients with or at risk of developing [opioid](/usc/21/802.md?p=18) and other substance use disorders. - (B) If the [practitioner](/usc/21/802.md?p=21) is not a physician (as defined under [section 1395x(r) of title 42](/usc/42/1395x.md?p=r)), the [practitioner](/usc/21/802.md?p=21) is legally [authorized](/usc/21/360eee–1.md?p=a-6) by the [State](/usc/21/802.md?p=26) to [dispense](/usc/21/802.md?p=10) [controlled substances](/usc/21/802.md?p=6) under schedule II, III, IV, or V and is dispensing such substances within such [State](/usc/21/802.md?p=26) in accordance with all applicable [State](/usc/21/802.md?p=26) laws, and the [practitioner](/usc/21/802.md?p=21) meets one or more of the following conditions: - (i) The [practitioner](/usc/21/802.md?p=21) has completed not fewer than 8 hours of training with respect to the treatment and management of patients with [opioid](/usc/21/802.md?p=18) or other substance use disorders (through classroom situations, seminars at professional society meetings, electronic communications, or otherwise) provided by the American Society of Addiction Medicine, the American Academy of Addiction Psychiatry, the American Medical Association, the American Osteopathic Association, the American Nurses Credentialing Center, the American Psychiatric Association, the American Association of Nurse [Practitioners](/usc/21/802.md?p=21), the American Academy of Physician Associates, the American Pharmacists Association, the Accreditation [Council](/usc/21/2011.md?p=1) on Pharmacy Education, the American Psychiatric Nurses Association, the American Academy of Nursing, the American Academy of Family Physicians, or any other organization approved or accredited by the Assistant [Secretary](/usc/21/802.md?p=24) for Mental Health and Substance Use, the American Academy of Family Physicians, or the Accreditation [Council](/usc/21/2011.md?p=1) for Continuing Medical Education. - (ii) The [practitioner](/usc/21/802.md?p=21) has graduated in good standing from an accredited physician assistant school, an accredited school of advanced practice nursing, or an accredited school of pharmacy in the [United States](/usc/21/802.md?p=28) during the 5-year period immediately preceding the date on which the [practitioner](/usc/21/802.md?p=21) first registers or renews under this section and has successfully completed a comprehensive physician assistant or advanced practice nursing curriculum that included not fewer than 8 hours of training on treating and managing patients with [opioid](/usc/21/802.md?p=18) and other substance use disorders, including the appropriate clinical use of all [drugs](/usc/21/321.md?p=g-1) approved by the [Food](/usc/21/346a.md?p=a-1) and [Drug](/usc/21/321.md?p=g-1) Administration for the treatment of a substance use disorder. - (2) **One-time training—** - (A) **In general—** The Attorney General shall not require any [qualified practitioner](#m-4-B) to complete the training described in clause [(iv)](#m-1-A-iv) or [(v)](#m-1-A-v) of paragraph (1)(A) or clause [(i)](#m-1-B-i) or [(ii)](#m-1-B-ii) of paragraph (1)(B) more than once. - (B) **Notification—** Not later than 90 days after December 29, 2022, the Attorney General shall provide to [qualified practitioners](#m-4-B) a single written, electronic notification of the training described in clauses [(iv)](#m-1-A-iv) and [(v)](#m-1-A-v) of paragraph (1)(A) or clauses [(i)](#m-1-B-i) and [(ii)](#m-1-B-ii) of paragraph (1)(B). - (3) **Rule of construction—** Nothing in this subsection shall be construed— - (A) to preclude the use, by a [qualified practitioner](#m-4-B), of training received pursuant to this subsection to satisfy registration requirements of a [State](/usc/21/802.md?p=26) or for some other lawful purpose; or - (B) to preempt any additional requirements by a [State](/usc/21/802.md?p=26) related to the dispensing of [controlled substances](/usc/21/802.md?p=6) under schedule II, III, IV, or V. - (4) **Definitions—** In this section: - (A) **First applicable registration—** The term “first applicable registration” means the first registration or renewal of registration by a [qualified practitioner](#m-4-B) under this section that occurs on or after the date that is 180 days after December 29, 2022. - (B) **Qualified practitioner—** In this subsection, the term “qualified practitioner” means a [practitioner](/usc/21/802.md?p=21) who— - (i) is [licensed](/usc/21/360eee–1.md?p=a-6) under [State](/usc/21/802.md?p=26) law to prescribe [controlled substances](/usc/21/802.md?p=6); and - (ii) is not solely a veterinarian. - (n) **Special provisions for practitioners conducting certain research with schedule I controlled substances—** - (1) **In general—** Notwithstanding [subsection (g)](#g), a [practitioner](/usc/21/802.md?p=21) may conduct research described in paragraph (2) of this subsection with 1 or more schedule I substances in accordance with subparagraph [(A)](#n-3-A) or [(B)](#n-3-B) of paragraph (3) of this subsection. - (2) **Research subject to expedited procedures—** Research described in this paragraph is research that— - (A) is with respect to a [drug](/usc/21/321.md?p=g-1) that is the subject of an investigational use exemption under [section 355(i) of this title](/usc/21/355.md?p=i); or - (B) is— - (i) conducted by the Department of Health and Human Services, the Department of Defense, or the Department of Veterans Affairs; or - (ii) funded partly or entirely by a grant, contract, cooperative agreement, or other transaction from the Department of Health and Human Services, the Department of Defense, or the Department of Veterans Affairs. - (3) **Expedited procedures—** - (A) **Researcher with a current schedule I or II research registration—** - (i) **In general—** If a [practitioner](/usc/21/802.md?p=21) is registered to conduct research with a [controlled substance](/usc/21/802.md?p=6) in schedule I or II, the [practitioner](/usc/21/802.md?p=21) may conduct research under this subsection on and after the date that is 30 days after the date on which the [practitioner](/usc/21/802.md?p=21) sends a notice to the Attorney General containing the following information, with respect to each substance with which the [practitioner](/usc/21/802.md?p=21) will conduct the research: - (I) The chemical name of the substance. - (II) The quantity of the substance to be used in the research. - (III) Demonstration that the research is in the category described in [paragraph (2)](#n-2), which demonstration may be satisfied— - (aa) in the case of a grant, contract, cooperative agreement, or other transaction, or intramural research project, by identifying the sponsoring agency and supplying the number of the grant, contract, cooperative agreement, other transaction, or project; or - (bb) in the case of an application under [section 355(i) of this title](/usc/21/355.md?p=i), by supplying the application number and the [sponsor](/usc/21/379j–71.md?p=13) of record on the application. - (IV) Demonstration that the researcher is [authorized](/usc/21/360eee–1.md?p=a-6) to conduct research with respect to the substance under the laws of the [State](/usc/21/802.md?p=26) in which the research will take place. - (ii) **Verification of information by HHS or VA—** Upon request from the Attorney General, the [Secretary](/usc/21/802.md?p=24) of Health and Human Services, the Department of Defense, or the [Secretary](/usc/21/802.md?p=24) of Veterans Affairs, as appropriate, shall [verify](/usc/21/360eee.md?p=28) information submitted by an applicant under [clause (i)(III)](#n-3-A-i-III). - (B) **Researcher without a current schedule I or II research registration—** - (i) **In general—** If a [practitioner](/usc/21/802.md?p=21) is not registered to conduct research with a [controlled substance](/usc/21/802.md?p=6) in schedule I or II, the [practitioner](/usc/21/802.md?p=21) may send a notice to the Attorney General containing the information listed in [subparagraph (A)(i)](#n-3-A-i), with respect to each substance with which the [practitioner](/usc/21/802.md?p=21) will conduct the research. - (ii) **Attorney General action—** The Attorney General shall— - (I) treat notice received under [clause (i)](#n-3-B-i) as a sufficient application for a research registration; and - (II) not later than 45 days of receiving such a notice that contains all information required under [subparagraph (A)(i)](#n-3-A-i)— - (aa) register the applicant; or - (bb) serve an order to show cause upon the applicant in accordance with [section 824(c) of this title](/usc/21/824.md?p=c). - (4) **Electronic submissions—** The Attorney General shall provide a means to permit a [practitioner](/usc/21/802.md?p=21) to submit a notification under [paragraph (3)](#n-3) electronically. - (5) **Limitation on amounts—** A [practitioner](/usc/21/802.md?p=21) conducting research with a schedule I substance under this subsection may only possess the amounts of schedule I substance identified in— - (A) the notification to the Attorney General under [paragraph (3)](#n-3); or - (B) a supplemental notification that the [practitioner](/usc/21/802.md?p=21) may send if the [practitioner](/usc/21/802.md?p=21) needs additional amounts for the research, which supplemental notification shall include— - (i) the name of the [practitioner](/usc/21/802.md?p=21); - (ii) the additional quantity needed of the substance; and - (iii) an attestation that the research to be conducted with the substance is consistent with the scope of the research that was the subject of the notification under [paragraph (3)](#n-3). - (6) **Importation and exportation requirements not affected—** Nothing in this subsection alters the requirements of subchapter II, regarding the importation and exportation of [controlled substances](/usc/21/802.md?p=6). - (7) **Inspector General report—** Not later than 1 year after July 16, 2025, the Inspector General of the Department of Justice shall complete a study, and submit to Congress a report thereon, about research described in paragraph (2) of this subsection with fentanyl. - (o) **Transparency regarding special procedures—** - (1) **In general—** If the Attorney General determines, with respect to a [controlled substance](/usc/21/802.md?p=6), that an application by a [practitioner](/usc/21/802.md?p=21) to conduct research with the substance should be considered under a process, or subject to criteria, different from the process or criteria applicable to applications to conduct research with other [controlled substances](/usc/21/802.md?p=6) in the same schedule, the Attorney General shall make public, including by posting on the website of the [Drug Enforcement Administration](/usc/21/802.md?p=4)— - (A) the identities of all substances for which such determinations have been made; - (B) the process and criteria that shall be applied to applications to conduct research with those substances; and - (C) how the process and criteria described in [subparagraph (B)](#o-1-B) differ from the process and criteria applicable to applications to conduct research with other [controlled substances](/usc/21/802.md?p=6) in the same schedule. - (2) **Timing of posting—** The Attorney General shall make information described in [paragraph (1)](#o-1) public upon making a determination described in that paragraph, regardless of whether a [practitioner](/usc/21/802.md?p=21) has submitted such an application at that time. # §824. Denial, revocation, or suspension of registration - (a) **Grounds—** A registration pursuant to [section 823 of this title](/usc/21/823.md) to [manufacture](/usc/21/802.md?p=15), [distribute](/usc/21/802.md?p=11), or [dispense](/usc/21/802.md?p=10) a [controlled substance](/usc/21/802.md?p=6) or a [list I chemical](/usc/21/802.md?p=34) may be suspended or revoked by the Attorney General upon a finding that the registrant— - (1) has materially falsified any application filed pursuant to or required by this subchapter or subchapter II; - (2) has been convicted of a [felony](/usc/21/802.md?p=13) under this subchapter or subchapter II or any other law of the [United States](/usc/21/802.md?p=28), or of any [State](/usc/21/802.md?p=26), relating to any substance defined in this subchapter as a [controlled substance](/usc/21/802.md?p=6) or a [list I chemical](/usc/21/802.md?p=34); - (3) has had his [State](/usc/21/802.md?p=26) license or registration suspended, revoked, or denied by competent [State](/usc/21/802.md?p=26) authority and is no longer [authorized](/usc/21/360eee–1.md?p=a-6) by [State](/usc/21/802.md?p=26) law to engage in the manufacturing, [distribution](/usc/21/360eee.md?p=5), or dispensing of [controlled substances](/usc/21/802.md?p=6) or [list I chemicals](/usc/21/802.md?p=34) or has had the suspension, revocation, or denial of his registration recommended by competent [State](/usc/21/802.md?p=26) authority; - (4) has committed such acts as would render his registration under [section 823 of this title](/usc/21/823.md) inconsistent with the public interest as determined under such section; or - (5) has been excluded (or directed to be excluded) from participation in a [program](/usc/21/1523.md?p=8) pursuant to [section 1320a–7(a) of title 42](/usc/42/1320a–7.md?p=a). A registration pursuant to [section 823(h) of this title](/usc/21/823.md?p=h) to [dispense](/usc/21/802.md?p=10) a [narcotic drug](/usc/21/802.md?p=17) for [maintenance treatment](/usc/21/802.md?p=29) or [detoxification treatment](/usc/21/802.md?p=30) may be suspended or revoked by the Attorney General upon a finding that the registrant has failed to comply with any standard referred to in [section 823(h) of this title](/usc/21/823.md?p=h). - (b) **Limits of revocation or suspension—** The Attorney General may limit revocation or suspension of a registration to the particular [controlled substance](/usc/21/802.md?p=6) or [list I chemical](/usc/21/802.md?p=34) with respect to which grounds for revocation or suspension exist. - (c) **Service of show cause order; proceedings—** - (1) Before taking action pursuant to this section, or pursuant to a denial of registration under [section 823 of this title](/usc/21/823.md), the Attorney General shall serve upon the applicant or registrant an order to show cause why registration should not be denied, revoked, or suspended. - (2) An order to show cause under [paragraph (1)](#c-1) shall— - (A) contain a statement of the basis for the denial, revocation, or suspension, including specific citations to any laws or regulations alleged to be violated by the applicant or registrant; - (B) direct the applicant or registrant to appear before the Attorney General at a time and place stated in the order, but not less than 30 days after the date of receipt of the order; and - (C) notify the applicant or registrant of the opportunity to submit a corrective action plan on or before the date of appearance. - (3) Upon review of any corrective action plan submitted by an applicant or registrant pursuant to [paragraph (2)](#c-2), the Attorney General shall determine whether denial, revocation, or suspension proceedings should be discontinued, or deferred for the purposes of modification, amendment, or clarification to such plan. - (4) Proceedings to deny, revoke, or suspend shall be conducted pursuant to this section in accordance with subchapter II of [chapter 5](/usc/5/chptI-ch5.md) of title 5. Such proceedings shall be independent of, and not in lieu of, criminal prosecutions or other proceedings under this subchapter or any other law of the [United States](/usc/21/802.md?p=28). - (5) The requirements of this subsection shall not apply to the issuance of an immediate suspension order under [subsection (d)](#d). - (d) **Suspension of registration in cases of imminent danger—** - (1) The Attorney General may, in his discretion, suspend any registration simultaneously with the institution of proceedings under this section, in cases where he finds that there is an imminent danger to the public health or safety. A failure to comply with a standard referred to in [section 823(h) of this title](/usc/21/823.md?p=h) may be treated under this subsection as grounds for immediate suspension of a registration granted under such section. A suspension under this subsection shall continue in effect until the conclusion of such proceedings, including judicial review thereof, unless sooner withdrawn by the Attorney General or dissolved by a court of competent jurisdiction. - (2) In this subsection, the phrase “imminent danger to the public health or safety” means that, due to the failure of the registrant to maintain effective [controls](/usc/21/802.md?p=5) against diversion or otherwise comply with the obligations of a registrant under this subchapter or subchapter II, there is a substantial likelihood of an immediate threat that death, serious bodily harm, or abuse of a [controlled substance](/usc/21/802.md?p=6) will occur in the absence of an immediate suspension of the registration. - (e) **Suspension and revocation of quotas—** The suspension or revocation of a registration under this section shall operate to suspend or revoke any quota applicable under [section 826 of this title](/usc/21/826.md). - (f) **Disposition of controlled substances or list I chemicals—** In the event the Attorney General suspends or revokes a registration granted under [section 823 of this title](/usc/21/823.md), all [controlled substances](/usc/21/802.md?p=6) or [list I chemicals](/usc/21/802.md?p=34) owned or possessed by the registrant pursuant to such registration at the time of suspension or the effective date of the revocation order, as the case may be, may, in the discretion of the Attorney General, be placed under seal. No disposition may be made of any [controlled substances](/usc/21/802.md?p=6) or [list I chemicals](/usc/21/802.md?p=34) under seal until the time for taking an appeal has elapsed or until all appeals have been concluded except that a court, upon application therefor, may at any time order the sale of perishable [controlled substances](/usc/21/802.md?p=6) or [list I chemicals](/usc/21/802.md?p=34). Any such order shall require the deposit of the proceeds of the sale with the court. Upon a revocation order becoming final, all such [controlled substances](/usc/21/802.md?p=6) or [list I chemicals](/usc/21/802.md?p=34) (or proceeds of sale deposited in court) shall be forfeited to the [United States](/usc/21/802.md?p=28); and the Attorney General shall dispose of such [controlled substances](/usc/21/802.md?p=6) or [list I chemicals](/usc/21/802.md?p=34) in accordance with [section 881(e) of this title](/usc/21/881.md?p=e). All right, title, and interest in such [controlled substances](/usc/21/802.md?p=6) or [list I chemicals](/usc/21/802.md?p=34) shall vest in the [United States](/usc/21/802.md?p=28) upon a revocation order becoming final. - (g) **Seizure or placement under seal of controlled substances or list I chemicals—** The Attorney General may, in his discretion, seize or place under seal any [controlled substances](/usc/21/802.md?p=6) or [list I chemicals](/usc/21/802.md?p=34) owned or possessed by a registrant whose registration has expired or who has ceased to practice or do business in the manner contemplated by his registration. Such [controlled substances](/usc/21/802.md?p=6) or [list I chemicals](/usc/21/802.md?p=34) shall be held for the benefit of the registrant, or his successor in interest. The Attorney General shall notify a registrant, or his successor in interest, who has any [controlled substance](/usc/21/802.md?p=6) or [list I chemical](/usc/21/802.md?p=34) seized or placed under seal of the procedures to be followed to secure the return of the [controlled substance](/usc/21/802.md?p=6) or [list I chemical](/usc/21/802.md?p=34) and the conditions under which it will be returned. The Attorney General may not dispose of any [controlled substance](/usc/21/802.md?p=6) or [list I chemical](/usc/21/802.md?p=34) seized or placed under seal under this subsection until the expiration of one hundred and eighty days from the date such substance or chemical was seized or placed under seal. - (h) **Order to prohibit registration based on prior history—** The Attorney General may issue an order to prohibit, conditionally or unconditionally, and permanently or for such period as the Attorney General may determine, any [person](/usc/21/379j–21.md?p=k-10) from being registered under this subchapter to [manufacture](/usc/21/802.md?p=15), [distribute](/usc/21/802.md?p=11), or [dispense](/usc/21/802.md?p=10) a [controlled substance](/usc/21/802.md?p=6) or a [list I chemical](/usc/21/802.md?p=34), if the Attorney General finds that— - (1) such [person](/usc/21/379j–21.md?p=k-10) meets or has met any of the conditions for suspension or revocation of registration under [subsection (a)](#a); and - (2) such [person](/usc/21/379j–21.md?p=k-10) has a history of prior suspensions or revocations of registration. # §825. Labeling and packaging - (a) **Symbol—** It shall be unlawful to [distribute](/usc/21/802.md?p=11) a [controlled substance](/usc/21/802.md?p=6) in a commercial container unless such container, when and as required by regulations of the Attorney General, bears a label (as defined in [section 321(k) of this title](/usc/21/321.md?p=k)) containing an identifying symbol for such substance in accordance with such regulations. A different symbol shall be required for each schedule of [controlled substances](/usc/21/802.md?p=6). - (b) **Unlawful distribution without identifying symbol—** It shall be unlawful for the [manufacturer](/usc/21/802.md?p=15) of any [controlled substance](/usc/21/802.md?p=6) to [distribute](/usc/21/802.md?p=11) such substance unless the labeling (as defined in [section 321(m) of this title](/usc/21/321.md?p=m)) of such substance contains, when and as required by regulations of the Attorney General, the identifying symbol required under [subsection (a)](#a). - (c) **Warning on label—** The [Secretary](/usc/21/802.md?p=24) shall prescribe regulations under [section 353(b) of this title](/usc/21/353.md?p=b) which shall provide that the label of a [drug](/usc/21/321.md?p=g-1) listed in schedule II, III, or IV shall, when dispensed to or for a patient, contain a clear, concise warning that it is a crime to transfer the [drug](/usc/21/321.md?p=g-1) to any [person](/usc/21/379j–21.md?p=k-10) other than the patient. - (d) **Containers to be securely sealed—** It shall be unlawful to [distribute](/usc/21/802.md?p=11) [controlled substances](/usc/21/802.md?p=6) in schedule I or II, and [narcotic drugs](/usc/21/802.md?p=17) in schedule III or IV, unless the bottle or other container, stopper, covering, or wrapper thereof is securely sealed as required by regulations of the Attorney General. - (e) **False labeling of anabolic steroids—** - (1) It shall be unlawful to import, export, [manufacture](/usc/21/802.md?p=15), [distribute](/usc/21/802.md?p=11), [dispense](/usc/21/802.md?p=10), or possess with intent to [manufacture](/usc/21/802.md?p=15), [distribute](/usc/21/802.md?p=11), or [dispense](/usc/21/802.md?p=10), an [anabolic steroid](/usc/21/802.md?p=41-A) or product containing an [anabolic steroid](/usc/21/802.md?p=41-A), unless the steroid or product bears a label clearly identifying an [anabolic steroid](/usc/21/802.md?p=41-A) or product containing an [anabolic steroid](/usc/21/802.md?p=41-A) by the nomenclature used by the International Union of Pure and Applied Chemistry (IUPAC). - (2) - (A) A product described in [subparagraph (B)](#e-2-B) is exempt from the International Union of Pure and Applied Chemistry nomenclature requirement of this subsection if such product is labeled in the manner required under the Federal [Food](/usc/21/346a.md?p=a-1), [Drug](/usc/21/321.md?p=g-1), and Cosmetic Act [[21 U.S.C. 301](/usc/21/301.md) et seq.]. - (B) A product is described in this subparagraph if the product— - (i) is the subject of an approved application as described in section 505(b) or (j) of the Federal [Food](/usc/21/346a.md?p=a-1), [Drug](/usc/21/321.md?p=g-1), and Cosmetic Act [[21 U.S.C. 355(b)](/usc/21/355.md?p=b), (j)]; or - (ii) is exempt from the provisions of section 505 of such Act relating to new [drugs](/usc/21/321.md?p=g-1) because— - (I) it is intended solely for investigational use as described in section 505(i) of such Act; and - (II) such product is being used exclusively for purposes of a clinical trial that is the subject of an effective investigational new [drug](/usc/21/321.md?p=g-1) application. # §826. Production quotas for controlled substances - (a) **Establishment of total annual needs—** - (1) The Attorney General shall determine the total quantity and establish [production](/usc/21/802.md?p=22) quotas for each basic class of [controlled substance](/usc/21/802.md?p=6) in schedules I and II and for ephedrine, pseudoephedrine, and phenylpropanolamine to be manufactured each calendar year to provide for the estimated medical, scientific, research, and industrial needs of the [United States](/usc/21/802.md?p=28), for lawful export requirements, and for the establishment and maintenance of reserve stocks. Except as provided in [paragraph (2)](#a-2), [production](/usc/21/802.md?p=22) quotas shall be established in terms of quantities of each basic class of [controlled substance](/usc/21/802.md?p=6) and not in terms of individual pharmaceutical dosage forms prepared from or containing such a [controlled substance](/usc/21/802.md?p=6). - (2) The Attorney General may, if the Attorney General determines it will assist in avoiding the overproduction, shortages, or diversion of a [controlled substance](/usc/21/802.md?p=6), establish an aggregate or individual [production](/usc/21/802.md?p=22) quota under this subsection, or a procurement quota established by the Attorney General by regulation, in terms of pharmaceutical dosage forms prepared from or containing the [controlled substance](/usc/21/802.md?p=6). - (b) **Individual manufacturing quotas; revised quotas—** The Attorney General shall limit or reduce individual manufacturing quotas to the extent necessary to prevent the aggregate of individual quotas from exceeding the amount determined necessary each year by the Attorney General under [subsection (a)](#a). The quota of each registered [manufacturer](/usc/21/802.md?p=15) for each basic class of [controlled substance](/usc/21/802.md?p=6) in schedule I or II or for ephedrine, pseudoephedrine, or phenylpropanolamine shall be revised in the same proportion as the limitation or reduction of the aggregate of the quotas. However, if any registrant, before the issuance of a limitation or reduction in quota, has manufactured in excess of his revised quota, the amount of the excess shall be subtracted from his quota for the following year. - (c) **Manufacturing quotas for registered manufacturers—** On or before December 1 of each year, upon application therefor by a registered [manufacturer](/usc/21/802.md?p=15), the Attorney General shall fix a manufacturing quota for the basic classes of [controlled substances](/usc/21/802.md?p=6) in schedules I and II and for ephedrine, pseudoephedrine, and phenylpropanolamine that the [manufacturer](/usc/21/802.md?p=15) seeks to produce. The quota shall be subject to the provisions of subsections [(a)](#a) and [(b)](#b) of this section. In fixing such quotas, the Attorney General shall determine the [manufacturer](/usc/21/802.md?p=15)’s estimated disposal, inventory, and other requirements for the calendar year; and, in making his determination, the Attorney General shall consider the [manufacturer](/usc/21/802.md?p=15)’s current rate of disposal, the trend of the national disposal rate during the preceding calendar year, the [manufacturer](/usc/21/802.md?p=15)’s [production](/usc/21/802.md?p=22) cycle and inventory position, the economic availability of raw materials, yield and stability problems, emergencies such as strikes and fires, and other factors. - (d) **Quotas for registrants who have not manufactured controlled substance during one or more preceding years—** The Attorney General shall, upon application and subject to the provisions of subsections [(a)](#a) and [(b)](#b) of this section, fix a quota for a basic class of [controlled substance](/usc/21/802.md?p=6) in schedule I or II for any registrant who has not manufactured that basic class of [controlled substance](/usc/21/802.md?p=6) or ephedrine, pseudoephedrine, or phenylpropanolamine during one or more preceding calendar years. In fixing such quota, the Attorney General shall take into account the registrant’s reasonably anticipated requirements for the current year; and, in making his determination of such requirements, he shall consider such factors specified in [subsection (c)](#c) of this section as may be relevant. - (e) **Quota increases—** At any time during the year any registrant who has applied for or received a manufacturing quota for a basic class of [controlled substance](/usc/21/802.md?p=6) in schedule I or II or for ephedrine, pseudoephedrine, or phenylpropanolamine may apply for an increase in that quota to meet his estimated disposal, inventory, and other requirements during the remainder of that year. In passing upon the application the Attorney General shall take into consideration any occurrences since the filing of the registrant’s initial quota application that may require an increased manufacturing rate by the registrant during the balance of the year. In passing upon the application the Attorney General may also take into account the amount, if any, by which the determination of the Attorney General under [subsection (a)](#a) of this section exceeds the aggregate of the quotas of all registrants under this section. - (f) **Incidental production exception—** Notwithstanding any other provisions of this subchapter, no registration or quota may be required for the [manufacture](/usc/21/802.md?p=15) of such quantities of [controlled substances](/usc/21/802.md?p=6) in schedules I and II or ephedrine, pseudoephedrine, or phenylpropanolamine as incidentally and necessarily result from the manufacturing process used for the [manufacture](/usc/21/802.md?p=15) of a [controlled substance](/usc/21/802.md?p=6) or of ephedrine, pseudoephedrine, or phenylpropanolamine with respect to which its [manufacturer](/usc/21/802.md?p=15) is duly registered under this subchapter. The Attorney General may, by regulation, prescribe restrictions on the retention and disposal of such incidentally produced substances or chemicals. - (g) **Reference to ephedrine, pseudoephedrine, or phenylpropanolamine—** Each reference in this section to ephedrine, pseudoephedrine, or phenylpropanolamine includes each of the salts, optical [isomers](/usc/21/802.md?p=14), and salts of optical [isomers](/usc/21/802.md?p=14) of such chemical. - (h) **Quotas applicable to drugs in shortage—** - (1) Not later than 30 days after the receipt of a request described in [paragraph (2)](#h-2), the Attorney General shall— - (A) complete review of such request; and - (B) - (i) as necessary to address a shortage of a [controlled substance](/usc/21/802.md?p=6), increase the aggregate and individual [production](/usc/21/802.md?p=22) quotas under this section applicable to such [controlled substance](/usc/21/802.md?p=6) and any ingredient therein to the level requested; or - (ii) if the Attorney General determines that the level requested is not necessary to address a shortage of a [controlled substance](/usc/21/802.md?p=6), the Attorney General shall provide a written response detailing the basis for the Attorney General’s determination. The [Secretary](/usc/21/802.md?p=24) shall make the written response provided under [subparagraph (B)(ii)](#h-1-B-ii) available to the public on the [Internet](/usc/21/802.md?p=50) Web site of the [Food](/usc/21/346a.md?p=a-1) and [Drug](/usc/21/321.md?p=g-1) Administration. - (2) A request is described in this paragraph if— - (A) the request pertains to a [controlled substance](/usc/21/802.md?p=6) on the list of [drugs](/usc/21/321.md?p=g-1) in shortage maintained under [section 356e of this title](/usc/21/356e.md); - (B) the request is submitted by the [manufacturer](/usc/21/802.md?p=15) of the [controlled substance](/usc/21/802.md?p=6); and - (C) the [controlled substance](/usc/21/802.md?p=6) is in schedule II. - (i) **Strengthening considerations for DEA opioid quotas—** - (1) - (A) In establishing any quota under this section, or any procurement quota established by the Attorney General by regulation, for fentanyl, oxycodone, hydrocodone, oxymorphone, or hydromorphone (in this subsection referred to as a “covered [controlled substance](/usc/21/802.md?p=6)”), the Attorney General shall estimate the amount of diversion of the covered [controlled substance](/usc/21/802.md?p=6) that occurs in the [United States](/usc/21/802.md?p=28). - (B) In estimating diversion under this paragraph, the Attorney General— - (i) shall consider information the Attorney General, in consultation with the [Secretary](/usc/21/802.md?p=24) of Health and Human Services, determines reliable on rates of overdose deaths and abuse and overall public health impact related to the covered [controlled substance](/usc/21/802.md?p=6) in the [United States](/usc/21/802.md?p=28); and - (ii) may take into consideration whatever other sources of information the Attorney General determines reliable. - (C) After estimating the amount of diversion of a covered [controlled substance](/usc/21/802.md?p=6), the Attorney General shall make appropriate quota reductions, as determined by the Attorney General, from the quota the Attorney General would have otherwise established had such diversion not been considered. - (2) - (A) For any year for which the approved aggregate [production](/usc/21/802.md?p=22) quota for a covered [controlled substance](/usc/21/802.md?p=6) is higher than the approved aggregate [production](/usc/21/802.md?p=22) quota for the covered [controlled substance](/usc/21/802.md?p=6) for the previous year, the Attorney General, in consultation with the [Secretary](/usc/21/802.md?p=24) of Health and Human Services, shall include in the final order an explanation of why the public health benefits of increasing the quota clearly outweigh the consequences of having an increased volume of the covered [controlled substance](/usc/21/802.md?p=6) available for sale, and potential diversion, in the [United States](/usc/21/802.md?p=28). - (B) Not later than 1 year after October 24, 2018, and every year thereafter, the Attorney General shall submit to the Committee on the Judiciary, the Committee on Health, Education, Labor, and Pensions, and the Committee on Appropriations of the Senate and the Committee on the Judiciary, the Committee on Energy and Commerce, and the Committee on Appropriations of the House of Representatives the following information with regard to each covered [controlled substance](/usc/21/802.md?p=6): - (i) An anonymized count of the total number of [manufacturers](/usc/21/802.md?p=15) issued individual manufacturing quotas that year for the covered [controlled substance](/usc/21/802.md?p=6). - (ii) An anonymized count of how many such [manufacturers](/usc/21/802.md?p=15) were issued an approved manufacturing quota that was higher than the quota issued to that [manufacturer](/usc/21/802.md?p=15) for the covered [controlled substance](/usc/21/802.md?p=6) in the previous year. - (3) Not later than 1 year after October 24, 2018, the Attorney General shall submit to Congress a report on how the Attorney General, when fixing and adjusting [production](/usc/21/802.md?p=22) and manufacturing quotas under this section for covered [controlled substances](/usc/21/802.md?p=6), will— - (A) take into consideration changes in the accepted medical use of the covered [controlled substances](/usc/21/802.md?p=6); and - (B) work with the [Secretary](/usc/21/802.md?p=24) of Health and Human Services on methods to appropriately and anonymously estimate the type and amount of covered [controlled substances](/usc/21/802.md?p=6) that are submitted for collection from approved [drug](/usc/21/321.md?p=g-1) collection receptacles, mail-back [programs](/usc/21/1523.md?p=8), and take-back events. # §826a. Attorney General report on drug shortages Not later than 6 months after July 9, 2012, and annually thereafter, the Attorney General shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on the Judiciary of the Senate a report on [drug](/usc/21/321.md?p=g-1) shortages that— - (1) identifies the number of requests received under [section 826(h) of this title](/usc/21/826.md?p=h) (as added by section 1005 of this Act), the average review time for such requests, the number of requests granted and denied under such section, and, for each of the requests denied under such section, the basis for such denial; - (2) describes the coordination between the [Drug Enforcement Administration](/usc/21/802.md?p=4) and [Food](/usc/21/346a.md?p=a-1) and [Drug](/usc/21/321.md?p=g-1) Administration on efforts to prevent or alleviate [drug](/usc/21/321.md?p=g-1) shortages; and - (3) identifies [drugs](/usc/21/321.md?p=g-1) containing a [controlled substance](/usc/21/802.md?p=6) subject to [section 826 of this title](/usc/21/826.md) when such a [drug](/usc/21/321.md?p=g-1) is determined by the [Secretary](/usc/21/802.md?p=24) to be in shortage. # §827. Records and reports of registrants - (a) **Inventory—** Except as provided in [subsection (c)](#c)— - (1) every registrant under this subchapter shall, on May 1, 1971, or as soon thereafter as such registrant first engages in the [manufacture](/usc/21/802.md?p=15), [distribution](/usc/21/360eee.md?p=5), or dispensing of [controlled substances](/usc/21/802.md?p=6), and every second year thereafter, make a complete and accurate record of all stocks thereof on hand, except that the regulations prescribed under this section shall permit each such biennial inventory (following the initial inventory required by this paragraph) to be prepared on such registrant’s regular general physical inventory date (if any) which is nearest to and does not vary by more than six months from the biennial date that would otherwise apply; - (2) on the effective date of each regulation of the Attorney General controlling a substance that immediately prior to such date was not a [controlled substance](/usc/21/802.md?p=6), each registrant under this subchapter manufacturing, distributing, or dispensing such substance shall make a complete and accurate record of all stocks thereof on hand; and - (3) on and after May 1, 1971, every registrant under this subchapter manufacturing, distributing, or dispensing a [controlled substance](/usc/21/802.md?p=6) or substances shall maintain, on a current basis, a complete and accurate record of each such substance manufactured, received, sold, delivered, or otherwise disposed of by him, except that this paragraph shall not require the maintenance of a perpetual inventory. - (b) **Availability of records—** Every inventory or other record required under this section (1) shall be in accordance with, and contain such relevant information as may be required by, regulations of the Attorney General, (2) shall (A) be maintained separately from all other records of the registrant, or (B) alternatively, in the case of nonnarcotic [controlled substances](/usc/21/802.md?p=6), be in such form that information required by the Attorney General is readily retrievable from the ordinary business records of the registrant, and (3) shall be kept and be available, for at least two years, for inspection and copying by officers or employees of the [United States](/usc/21/802.md?p=28) [authorized](/usc/21/360eee–1.md?p=a-6) by the Attorney General. - (c) **Nonapplicability—** The foregoing provisions of this section shall not apply— - (1) - (A) to the prescribing of [controlled substances](/usc/21/802.md?p=6) in schedule II, III, IV, or V by [practitioners](/usc/21/802.md?p=21) acting in the lawful course of their professional practice unless such substance is prescribed in the course of maintenance or [detoxification treatment](/usc/21/802.md?p=30) of an individual; or - (B) to the administering of a [controlled substance](/usc/21/802.md?p=6) in schedule II, III, IV, or V unless the [practitioner](/usc/21/802.md?p=21) regularly engages in the dispensing or administering of [controlled substances](/usc/21/802.md?p=6) and charges his patients, either separately or together with charges for other professional services, for substances so dispensed or administered or unless such substance is administered in the course of [maintenance treatment](/usc/21/802.md?p=29) or [detoxification treatment](/usc/21/802.md?p=30) of an individual; - (2) - (A) to the use of [controlled substances](/usc/21/802.md?p=6), at establishments registered under this subchapter which keep records with respect to such substances, in research conducted in conformity with an exemption granted under section [355(i)](/usc/21/355.md?p=i) or [360b(j)](/usc/21/360b.md?p=j) of this title; - (B) to the use of [controlled substances](/usc/21/802.md?p=6), at establishments registered under this subchapter which keep records with respect to such substances, in preclinical research or in teaching; or - (3) to the extent of any exemption granted to any [person](/usc/21/379j–21.md?p=k-10), with respect to all or part of such provisions, by the Attorney General by or pursuant to regulation on the basis of a finding that the application of such provisions (or part thereof) to such [person](/usc/21/379j–21.md?p=k-10) is not necessary for carrying out the purposes of this subchapter. Nothing in the [Convention on Psychotropic Substances](/usc/21/802.md?p=31) shall be construed as superseding or otherwise affecting the provisions of paragraph (1)(B), (2), or (3) of this subsection. - (d) **Periodic reports to Attorney General—** - (1) Every [manufacturer](/usc/21/802.md?p=15) registered under [section 823 of this title](/usc/21/823.md) shall, at such time or times and in such form as the Attorney General may require, make periodic reports to the Attorney General of every sale, [delivery](/usc/21/802.md?p=8) or other disposal by him of any [controlled substance](/usc/21/802.md?p=6), and each [distributor](/usc/21/802.md?p=11) shall make such reports with respect to narcotic [controlled substances](/usc/21/802.md?p=6), identifying by the registration number assigned under this subchapter the [person](/usc/21/379j–21.md?p=k-10) or establishment (unless exempt from registration under [section 822(d) of this title](/usc/21/822.md?p=d)) to whom such sale, [delivery](/usc/21/802.md?p=8), or other disposal was made. - (2) Each pharmacy with a modified registration under [section 823(g) of this title](/usc/21/823.md?p=g) that authorizes the dispensing of [controlled substances](/usc/21/802.md?p=6) by means of the [Internet](/usc/21/802.md?p=50) shall report to the Attorney General the [controlled substances](/usc/21/802.md?p=6) it [dispenses](/usc/21/802.md?p=10), in the amount specified, and in such time and manner as the Attorney General by regulation shall require, except that the Attorney General, under this paragraph, may not require any pharmacy to report any information other than the total quantity of each [controlled substance](/usc/21/802.md?p=6) that the pharmacy has dispensed each month. For purposes of this paragraph, no reporting shall be required unless the pharmacy has met 1 of the following thresholds in the month for which the reporting is required: - (A) 100 or more prescriptions dispensed. - (B) 5,000 or more dosage units of all [controlled substances](/usc/21/802.md?p=6) combined. - (e) **Reporting and recordkeeping requirements of drug conventions—** In addition to the reporting and recordkeeping requirements under any other provision of this subchapter, each [manufacturer](/usc/21/802.md?p=15) registered under [section 823 of this title](/usc/21/823.md) shall, with respect to narcotic and nonnarcotic [controlled substances](/usc/21/802.md?p=6) manufactured by it, make such reports to the Attorney General, and maintain such records, as the Attorney General may require to enable the [United States](/usc/21/802.md?p=28) to meet its obligations under articles 19 and 20 of the [Single Convention on Narcotic Drugs](/usc/21/802.md?p=31) and article 16 of the [Convention on Psychotropic Substances](/usc/21/802.md?p=31). The Attorney General shall [administer](/usc/21/802.md?p=2) the requirements of this subsection in such a manner as to avoid the unnecessary imposition of duplicative requirements under this subchapter on [manufacturers](/usc/21/802.md?p=15) subject to the requirements of this subsection. - (f) **Records and reports of registrants—** - (1) The Attorney General shall, not less frequently than quarterly, make the following information available to [manufacturer](/usc/21/802.md?p=15) and [distributor](/usc/21/802.md?p=11) registrants through the Automated Reports and Consolidated Orders System, or any subsequent automated system developed by the [Drug Enforcement Administration](/usc/21/802.md?p=4) to monitor selected [controlled substances](/usc/21/802.md?p=6): - (A) The total number of [distributor](/usc/21/802.md?p=11) registrants that [distribute](/usc/21/802.md?p=11) [controlled substances](/usc/21/802.md?p=6) to a pharmacy or [practitioner](/usc/21/802.md?p=21) registrant, aggregated by the name and address of each pharmacy and [practitioner](/usc/21/802.md?p=21) registrant. - (B) The total quantity and type of [opioids](/usc/21/802.md?p=18) distributed, listed by Administration Controlled Substances Code Number, to each pharmacy and [practitioner](/usc/21/802.md?p=21) registrant described in [subparagraph (A)](#f-1-A). - (2) The information required to be made available under [paragraph (1)](#f-1) shall be made available not later than the 30th day of the first month following the quarter to which the information relates. - (3) - (A) All registered [manufacturers](/usc/21/802.md?p=15) and [distributors](/usc/21/802.md?p=11) shall be responsible for reviewing the information made available by the Attorney General under this subsection. - (B) In determining whether to initiate proceedings under this subchapter against a registered [manufacturer](/usc/21/802.md?p=15) or [distributor](/usc/21/802.md?p=11) based on the failure of the registrant to maintain effective [controls](/usc/21/802.md?p=5) against diversion or otherwise comply with the requirements of this subchapter or the regulations issued thereunder, the Attorney General may take into account that the information made available under this subsection was available to the registrant. - (g) **Investigational uses of drugs; procedures—** Regulations under sections [355(i)](/usc/21/355.md?p=i) and [360(j)](/usc/21/360.md?p=j) of this title, relating to investigational use of [drugs](/usc/21/321.md?p=g-1), shall include such procedures as the [Secretary](/usc/21/802.md?p=24), after consultation with the Attorney General, determines are necessary to insure the security and accountability of [controlled substances](/usc/21/802.md?p=6) used in research to which such regulations apply. - (h) **Change of address—** Every registrant under this subchapter shall be required to report any change of professional or business address in such manner as the Attorney General shall by regulation require. - (i) **Reporting requirements for GHB—** In the case of a [drug product](/usc/21/321.md?p=dd) containing gamma hydroxybutyric acid for which an application has been approved under [section 355 of this title](/usc/21/355.md), the Attorney General may, in addition to any other requirements that apply under this section with respect to such a [drug product](/usc/21/321.md?p=dd), establish any of the following as reporting requirements: - (1) That every [person](/usc/21/379j–21.md?p=k-10) who is registered as a [manufacturer](/usc/21/802.md?p=15) of bulk or dosage form, as a packager, repackager, labeler, relabeler, or [distributor](/usc/21/802.md?p=11) shall report acquisition and [distribution](/usc/21/360eee.md?p=5) transactions quarterly, not later than the 15th day of the month succeeding the quarter for which the report is submitted, and annually report end-of-year inventories. - (2) That all annual inventory reports shall be filed no later than January 15 of the year following that for which the report is submitted and include data on the stocks of the [drug product](/usc/21/321.md?p=dd), [drug](/usc/21/321.md?p=g-1) substance, bulk [drug](/usc/21/321.md?p=g-1), and dosage forms on hand as of the close of business December 31, indicating whether materials reported are in storage or in process of manufacturing. - (3) That every [person](/usc/21/379j–21.md?p=k-10) who is registered as a [manufacturer](/usc/21/802.md?p=15) of bulk or dosage form shall report all manufacturing transactions both inventory increases, including purchases, transfers, and returns, and reductions from inventory, including sales, transfers, theft, destruction, and seizure, and shall provide data on material manufactured, manufactured from other material, use in manufacturing other material, and use in manufacturing dosage forms. - (4) That all reports under this section must include the registered [person](/usc/21/379j–21.md?p=k-10)’s registration number as well as the registration numbers, names, and other identifying information of vendors, suppliers, and customers, sufficient to allow the Attorney General to track the receipt and [distribution](/usc/21/360eee.md?p=5) of the [drug](/usc/21/321.md?p=g-1). - (5) That each dispensing [practitioner](/usc/21/802.md?p=21) shall maintain for each prescription the name of the prescribing [practitioner](/usc/21/802.md?p=21), the prescribing [practitioner](/usc/21/802.md?p=21)’s Federal and [State](/usc/21/802.md?p=26) registration numbers, with the expiration dates of these registrations, [verification](/usc/21/360eee.md?p=28) that the prescribing [practitioner](/usc/21/802.md?p=21) possesses the appropriate registration to prescribe this [controlled substance](/usc/21/802.md?p=6), the patient’s name and address, the name of the patient’s insurance provider and documentation by a medical [practitioner](/usc/21/802.md?p=21) [licensed](/usc/21/360eee–1.md?p=a-6) and registered to prescribe the [drug](/usc/21/321.md?p=g-1) of the patient’s medical need for the [drug](/usc/21/321.md?p=g-1). Such information shall be available for inspection and copying by the Attorney General. - (6) That [section 830(b)(3) of this title](/usc/21/830.md?p=b-3) (relating to mail order reporting) applies with respect to gamma hydroxybutyric acid to the same extent and in the same manner as such section applies with respect to the chemicals and [drug products](/usc/21/321.md?p=dd) specified in [subparagraph (A)(i)](/usc/21/830.md?p=b-3-A-i) of such section. - (j) **Electronic reporting format—** All of the reports required under this section shall be provided in an electronic format. # §828. Order forms - (a) **Unlawful distribution of controlled substances—** It shall be unlawful for any [person](/usc/21/379j–21.md?p=k-10) to [distribute](/usc/21/802.md?p=11) a [controlled substance](/usc/21/802.md?p=6) in schedule I or II to another except in pursuance of a written order of the [person](/usc/21/379j–21.md?p=k-10) to whom such substance is distributed, made on a form to be issued by the Attorney General in blank in accordance with [subsection (d)](#d) and regulations prescribed by him pursuant to this section. - (b) **Nonapplicability of provisions—** Nothing in [subsection (a)](#a) shall apply to— - (1) the exportation of such substances from the [United States](/usc/21/802.md?p=28) in conformity with subchapter II; - (2) the [delivery](/usc/21/802.md?p=8) of such a substance to or by a common or contract carrier for carriage in the lawful and usual course of its business, or to or by a warehouseman for storage in the lawful and usual course of its business; but where such carriage or storage is in connection with the [distribution](/usc/21/360eee.md?p=5) by the owner of the substance to a third [person](/usc/21/379j–21.md?p=k-10), this paragraph shall not relieve the [distributor](/usc/21/802.md?p=11) from compliance with [subsection (a)](#a); or - (3) the [delivery](/usc/21/802.md?p=8) of such a substance for the purpose of disposal by an [ultimate user](/usc/21/802.md?p=27), long-term care [facility](/usc/21/350g.md?p=o-2), or other [person](/usc/21/379j–21.md?p=k-10) acting in accordance with [section 822(g) of this title](/usc/21/822.md?p=g). - (c) **Preservation and availability—** - (1) Every [person](/usc/21/379j–21.md?p=k-10) who in pursuance of an order required under [subsection (a)](#a) [distributes](/usc/21/802.md?p=11) a [controlled substance](/usc/21/802.md?p=6) shall preserve such order for a period of two years, and shall make such order available for inspection and copying by officers and employees of the [United States](/usc/21/802.md?p=28) duly [authorized](/usc/21/360eee–1.md?p=a-6) for that purpose by the Attorney General, and by officers or employees of [States](/usc/21/802.md?p=26) or their political subdivisions who are charged with the enforcement of [State](/usc/21/802.md?p=26) or local laws regulating the [production](/usc/21/802.md?p=22), or regulating the [distribution](/usc/21/360eee.md?p=5) or dispensing, of [controlled substances](/usc/21/802.md?p=6) and who are [authorized](/usc/21/360eee–1.md?p=a-6) under such laws to inspect such orders. - (2) Every [person](/usc/21/379j–21.md?p=k-10) who gives an order required under [subsection (a)](#a) shall, at or before the time of giving such order, make or cause to be made a duplicate thereof on a form to be issued by the Attorney General in blank in accordance with [subsection (d)](#d) and regulations prescribed by him pursuant to this section, and shall, if such order is accepted, preserve such duplicate for a period of two years and make it available for inspection and copying by the officers and employees mentioned in paragraph (1) of this subsection. - (d) **Issuance—** - (1) The Attorney General shall issue forms pursuant to subsections [(a)](#a) and [(c)(2)](#c-2) only to [persons](/usc/21/379j–21.md?p=k-10) validly registered under [section 823 of this title](/usc/21/823.md) (or exempted from registration under [section 822(d) of this title](/usc/21/822.md?p=d)). Whenever any such form is issued to a [person](/usc/21/379j–21.md?p=k-10), the Attorney General shall, before [delivery](/usc/21/802.md?p=8) thereof, insert therein the name of such [person](/usc/21/379j–21.md?p=k-10), and it shall be unlawful for any other [person](/usc/21/379j–21.md?p=k-10) (A) to use such form for the purpose of obtaining [controlled substances](/usc/21/802.md?p=6) or (B) to furnish such form to any [person](/usc/21/379j–21.md?p=k-10) with intent thereby to procure the [distribution](/usc/21/360eee.md?p=5) of such substances. - (2) The Attorney General may charge reasonable fees for the issuance of such forms in such amounts as he may prescribe for the purpose of covering the cost to the [United States](/usc/21/802.md?p=28) of issuing such forms, and other necessary activities in connection therewith. - (e) **Unlawful acts—** It shall be unlawful for any [person](/usc/21/379j–21.md?p=k-10) to obtain by means of order forms issued under this section [controlled substances](/usc/21/802.md?p=6) for any purpose other than their use, [distribution](/usc/21/360eee.md?p=5), dispensing, or administration in the conduct of a lawful business in such substances or in the course of his professional practice or research. # §829. Prescriptions - (a) **Schedule II substances—** Except when dispensed directly by a [practitioner](/usc/21/802.md?p=21), other than a pharmacist, to an [ultimate user](/usc/21/802.md?p=27), no [controlled substance](/usc/21/802.md?p=6) in schedule II, which is a [prescription drug](/usc/21/360eee.md?p=12) as determined under the Federal [Food](/usc/21/346a.md?p=a-1), [Drug](/usc/21/321.md?p=g-1), and Cosmetic Act [[21 U.S.C. 301](/usc/21/301.md) et seq.], may be dispensed without the written prescription of a [practitioner](/usc/21/802.md?p=21), except that in emergency situations, as prescribed by the [Secretary](/usc/21/802.md?p=24) by regulation after consultation with the Attorney General, such [drug](/usc/21/321.md?p=g-1) may be dispensed upon oral prescription in accordance with section 503(b) of that Act [[21 U.S.C. 353(b)](/usc/21/353.md?p=b)]. Prescriptions shall be retained in conformity with the requirements of [section 827 of this title](/usc/21/827.md). No prescription for a [controlled substance](/usc/21/802.md?p=6) in schedule II may be refilled. - (b) **Schedule III and IV substances—** Except when dispensed directly by a [practitioner](/usc/21/802.md?p=21), other than a pharmacist, to an [ultimate user](/usc/21/802.md?p=27), no [controlled substance](/usc/21/802.md?p=6) in schedule III or IV, which is a [prescription drug](/usc/21/360eee.md?p=12) as determined under the Federal [Food](/usc/21/346a.md?p=a-1), [Drug](/usc/21/321.md?p=g-1), and Cosmetic Act [[21 U.S.C. 301](/usc/21/301.md) et seq.], may be dispensed without a written or oral prescription in conformity with section 503(b) of that Act [[21 U.S.C. 353(b)](/usc/21/353.md?p=b)]. Such prescriptions may not be filled or refilled more than six months after the date thereof or be refilled more than five times after the date of the prescription unless renewed by the [practitioner](/usc/21/802.md?p=21). - (c) **Schedule V substances—** No [controlled substance](/usc/21/802.md?p=6) in schedule V which is a [drug](/usc/21/321.md?p=g-1) may be distributed or dispensed other than for a medical purpose. - (d) **Non-prescription drugs with abuse potential—** Whenever it appears to the Attorney General that a [drug](/usc/21/321.md?p=g-1) not considered to be a [prescription drug](/usc/21/360eee.md?p=12) under the Federal [Food](/usc/21/346a.md?p=a-1), [Drug](/usc/21/321.md?p=g-1), and Cosmetic Act [[21 U.S.C. 301](/usc/21/301.md) et seq.] should be so considered because of its abuse potential, he shall so advise the [Secretary](/usc/21/802.md?p=24) and furnish to him all available data relevant thereto. - (e) **Controlled substances dispensed by means of the Internet—** - (1) No [controlled substance](/usc/21/802.md?p=6) that is a [prescription drug](/usc/21/360eee.md?p=12) as determined under the Federal [Food](/usc/21/346a.md?p=a-1), [Drug](/usc/21/321.md?p=g-1), and Cosmetic Act [[21 U.S.C. 301](/usc/21/301.md) et seq.] may be delivered, distributed, or dispensed by means of the [Internet](/usc/21/802.md?p=50) without a [valid prescription](#e-2-A). - (2) As used in this subsection: - (A) The term “valid prescription” means a prescription that is issued for a legitimate medical purpose in the usual course of professional practice by— - (i) a [practitioner](/usc/21/802.md?p=21) who has conducted at least 1 [in-person medical evaluation](#e-2-B-i) of the patient; or - (ii) a [covering practitioner](#e-2-C). - (B) - (i) The term “in-person medical evaluation” means a medical evaluation that is conducted with the patient in the physical presence of the [practitioner](/usc/21/802.md?p=21), without regard to whether portions of the evaluation are conducted by other health professionals. - (ii) Nothing in [clause (i)](#e-2-B-i) shall be construed to imply that 1 [in-person medical evaluation](#e-2-B-i) demonstrates that a prescription has been issued for a legitimate medical purpose within the usual course of professional practice. - (C) The term “covering practitioner” means, with respect to a patient, a [practitioner](/usc/21/802.md?p=21) who conducts a medical evaluation (other than an [in-person medical evaluation](#e-2-B-i)) at the request of a [practitioner](/usc/21/802.md?p=21) who— - (i) has conducted at least 1 [in-person medical evaluation](#e-2-B-i) of the patient or an evaluation of the patient through the [practice of telemedicine](/usc/21/802.md?p=54), within the previous 24 months; and - (ii) is temporarily unavailable to conduct the evaluation of the patient. - (3) Nothing in this subsection shall apply to— - (A) the [delivery](/usc/21/802.md?p=8), [distribution](/usc/21/360eee.md?p=5), or dispensing of a [controlled substance](/usc/21/802.md?p=6) by a [practitioner](/usc/21/802.md?p=21) engaged in the [practice of telemedicine](/usc/21/802.md?p=54); or - (B) the dispensing or selling of a [controlled substance](/usc/21/802.md?p=6) pursuant to practices as determined by the Attorney General by regulation, which shall be consistent with effective [controls](/usc/21/802.md?p=5) against diversion. - (f) **Partial fills of schedule II controlled substances—** - (1) **Partial fills—** A prescription for a [controlled substance](/usc/21/802.md?p=6) in schedule II may be partially filled if— - (A) it is not prohibited by [State](/usc/21/802.md?p=26) law; - (B) the prescription is written and filled in accordance with this subchapter, regulations prescribed by the Attorney General, and [State](/usc/21/802.md?p=26) law; - (C) the partial fill is requested by the patient or the [practitioner](/usc/21/802.md?p=21) that wrote the prescription; and - (D) the total quantity dispensed in all partial fillings does not exceed the total quantity prescribed. - (2) **Remaining portions—** - (A) **In general—** Except as provided in [subparagraph (B)](#f-2-B), remaining portions of a partially filled prescription for a [controlled substance](/usc/21/802.md?p=6) in schedule II— - (i) may be filled; and - (ii) shall be filled not later than 30 days after the date on which the prescription is written. - (B) **Emergency situations—** In emergency situations, as described in [subsection (a)](#a), the remaining portions of a partially filled prescription for a [controlled substance](/usc/21/802.md?p=6) in schedule II— - (i) may be filled; and - (ii) shall be filled not later than 72 hours after the prescription is issued. - (3) **Currently lawful partial fills—** Notwithstanding paragraph [(1)](#f-1) or [(2)](#f-2), in any circumstance in which, as of the day before July 22, 2016, a prescription for a [controlled substance](/usc/21/802.md?p=6) in schedule II may be lawfully partially filled, the Attorney General may allow such a prescription to be partially filled. # §829a. Delivery of a controlled substance by a pharmacy to an administering practitioner - (a) **In general—** Notwithstanding [section 802(10) of this title](/usc/21/802.md?p=10), a pharmacy may [deliver](/usc/21/802.md?p=8) a [controlled substance](/usc/21/802.md?p=6) to a [practitioner](/usc/21/802.md?p=21) in accordance with a prescription that meets the requirements of this subchapter and the regulations issued by the Attorney General under this subchapter, for the purpose of administering the [controlled substance](/usc/21/802.md?p=6) by the [practitioner](/usc/21/802.md?p=21) if— - (1) the [controlled substance](/usc/21/802.md?p=6) is delivered by the pharmacy to the prescribing [practitioner](/usc/21/802.md?p=21) or the [practitioner](/usc/21/802.md?p=21) administering the [controlled substance](/usc/21/802.md?p=6), as applicable, at the location listed on the [practitioner](/usc/21/802.md?p=21)’s certificate of registration issued under this subchapter; - (2) the [controlled substance](/usc/21/802.md?p=6) is a [drug](/usc/21/321.md?p=g-1) in schedule III, IV, or V to be administered— - (A) by injection or implantation for the purpose of maintenance or [detoxification treatment](/usc/21/802.md?p=30); or - (B) subject to a risk evaluation and mitigation [strategy](/usc/21/1701.md?p=12) pursuant to [section 355–1 of this title](/usc/21/355–1.md) that includes elements to assure safe use of the [drug](/usc/21/321.md?p=g-1) described in [subsection (f)(3)(E)](/usc/21/355–1.md?p=f-3-E) of such section, including a requirement for post-administration monitoring by a health care provider; - (3) the pharmacy and the [practitioner](/usc/21/802.md?p=21) are [authorized](/usc/21/360eee–1.md?p=a-6) to conduct the activities specified in this section under the law of the [State](/usc/21/802.md?p=26) in which such activities take place; - (4) the prescription is not issued to supply any [practitioner](/usc/21/802.md?p=21) with a stock of [controlled substances](/usc/21/802.md?p=6) for the purpose of general dispensing to patients; - (5) except as provided in [subsection (b)](#b), the [controlled substance](/usc/21/802.md?p=6) is to be administered only to the patient named on the prescription not later than 45 days after the date of receipt of the [controlled substance](/usc/21/802.md?p=6) by the [practitioner](/usc/21/802.md?p=21); and - (6) notwithstanding any exceptions under [section 827 of this title](/usc/21/827.md), the prescribing [practitioner](/usc/21/802.md?p=21), and the [practitioner](/usc/21/802.md?p=21) administering the [controlled substance](/usc/21/802.md?p=6), as applicable, maintain complete and accurate records of all [controlled substances](/usc/21/802.md?p=6) delivered, received, administered, or otherwise disposed of under this section, including the [persons](/usc/21/379j–21.md?p=k-10) to whom [controlled substances](/usc/21/802.md?p=6) were delivered and such other information as may be required by regulations of the Attorney General. - (b) **Modification of number of days before which controlled substance shall be administered—** - (1) **Initial 2-year period—** During the 2-year period beginning on October 24, 2018, the Attorney General, in coordination with the [Secretary](/usc/21/802.md?p=24), may reduce the number of days described in [subsection (a)(5)](#a-5) if the Attorney General determines that such reduction will— - (A) reduce the risk of diversion; or - (B) protect the public health. - (2) **Modifications after submission of report—** After the date on which the report described in section 3204(b) of the SUPPORT for Patients and Communities Act is submitted, the Attorney General, in coordination with the [Secretary](/usc/21/802.md?p=24), may modify the number of days described in [subsection (a)(5)](#a-5). - (3) **Minimum number of days—** Any modification under this subsection shall be for a period of not less than 7 days. # §830. Regulation of listed chemicals and certain machines - (a) **Record of regulated transactions—** - (1) Each [regulated person](/usc/21/802.md?p=38) who engages in a [regulated transaction](/usc/21/802.md?p=39) involving a [listed chemical](/usc/21/802.md?p=33), a tableting machine, or an encapsulating machine shall keep a record of the transaction for two years after the date of the transaction. - (2) A record under this subsection shall be retrievable and shall include the date of the [regulated transaction](/usc/21/802.md?p=39), the identity of each party to the [regulated transaction](/usc/21/802.md?p=39), a statement of the quantity and form of the [listed chemical](/usc/21/802.md?p=33), a description of the tableting machine or encapsulating machine, and a description of the method of transfer. Such record shall be available for inspection and copying by the Attorney General. - (3) It is the duty of each [regulated person](/usc/21/802.md?p=38) who engages in a [regulated transaction](/usc/21/802.md?p=39) to identify each other party to the transaction. It is the duty of such other party to present proof of identity to the [regulated person](/usc/21/802.md?p=38). The Attorney General shall specify by regulation the types of documents and other evidence that constitute proof of identity for purposes of this paragraph. - (b) **Reports to Attorney General—** - (1) Each [regulated person](/usc/21/802.md?p=38) shall report to the Attorney General, in such form and manner as the Attorney General shall prescribe by regulation— - (A) any [regulated transaction](/usc/21/802.md?p=39) involving an extraordinary quantity of a [listed chemical](/usc/21/802.md?p=33), an uncommon method of payment or [delivery](/usc/21/802.md?p=8), or any other circumstance that the [regulated person](/usc/21/802.md?p=38) believes may indicate that the [listed chemical](/usc/21/802.md?p=33) will be used in violation of this subchapter; - (B) any proposed [regulated transaction](/usc/21/802.md?p=39) with a [person](/usc/21/379j–21.md?p=k-10) whose description or other identifying characteristic the Attorney General furnishes in advance to the [regulated person](/usc/21/802.md?p=38); - (C) any unusual or excessive loss or disappearance of a [listed chemical](/usc/21/802.md?p=33) under the [control](/usc/21/802.md?p=5) of the [regulated person](/usc/21/802.md?p=38); and - (D) any [regulated transaction](/usc/21/802.md?p=39) in a tableting machine or an encapsulating machine. Each report under [subparagraph (A)](#b-1-A) shall be made at the earliest practicable opportunity after the [regulated person](/usc/21/802.md?p=38) becomes aware of the circumstance involved. A [regulated person](/usc/21/802.md?p=38) may not complete a transaction with a [person](/usc/21/379j–21.md?p=k-10) whose description or identifying characteristic is furnished to the [regulated person](/usc/21/802.md?p=38) under [subparagraph (B)](#b-1-B) unless the transaction is approved by the Attorney General. The Attorney General shall make available to [regulated persons](/usc/21/802.md?p=38) guidance documents describing transactions and circumstances for which reports are required under [subparagraph (A)](#b-1-A) and [subparagraph (C)](#b-1-C). - (2) A [regulated person](/usc/21/802.md?p=38) that [manufactures](/usc/21/802.md?p=15) a [listed chemical](/usc/21/802.md?p=33) shall report annually to the Attorney General, in such form and manner and containing such specific data as the Attorney General shall prescribe by regulation, information concerning [listed chemicals](/usc/21/802.md?p=33) manufactured by the [person](/usc/21/379j–21.md?p=k-10). The requirement of the preceding sentence shall not apply to the [manufacture](/usc/21/802.md?p=15) of a [drug product](/usc/21/321.md?p=dd) that is exempted under [section 802(39)(A)(iv) of this title](/usc/21/802.md?p=39-A-iv). - (3) **Mail order reporting.—** - (A) As used in this paragraph: - (i) The term “drug product” means an active ingredient in dosage form that has been approved or otherwise may be lawfully marketed under the [Food](/usc/21/346a.md?p=a-1), [Drug](/usc/21/321.md?p=g-1), and Cosmetic Act[^1] [[21 U.S.C. 301](/usc/21/301.md) et seq.] for [distribution](/usc/21/360eee.md?p=5) in the [United States](/usc/21/802.md?p=28). - (ii) The term “valid prescription” means a prescription which is issued for a legitimate medical purpose by an individual [practitioner](/usc/21/802.md?p=21) [licensed](/usc/21/360eee–1.md?p=a-6) by law to [administer](/usc/21/802.md?p=2) and prescribe the [drugs](/usc/21/321.md?p=g-1) concerned and acting in the usual course of the [practitioner](/usc/21/802.md?p=21)’s professional practice. - (B) Each [regulated person](/usc/21/802.md?p=38) who engages in a transaction with a nonregulated person or who engages in an export transaction which— - (i) involves ephedrine, pseudoephedrine, or phenylpropanolamine (including [drug products](#b-3-A-i) containing these chemicals); and - (ii) uses or attempts to use the Postal Service or any private or commercial carrier; shall, on a monthly basis, submit a report of each such transaction conducted during the previous month to the Attorney General in such form, containing such data, and at such times as the Attorney General shall establish by regulation. - (C) The data required for such reports shall include— - (i) the name of the purchaser; - (ii) the quantity and form of the ephedrine, pseudoephedrine, or phenylpropanolamine purchased; and - (iii) the address to which such ephedrine, pseudoephedrine, or phenylpropanolamine was sent. - (D) Except as provided in [subparagraph (E)](#b-3-E), the following [distributions](/usc/21/360eee.md?p=5) to a nonregulated person, and the following export transactions, shall not be subject to the reporting requirement in [subparagraph (B)](#b-3-B): - (i) [Distributions](/usc/21/360eee.md?p=5) of sample packages of [drug products](#b-3-A-i) when such packages contain not more than two solid dosage units or the equivalent of two dosage units in liquid form, not to exceed 10 milliliters of liquid per package, and not more than one package is distributed to an individual or residential address in any 30-day period. - (ii) [Distributions](/usc/21/360eee.md?p=5) of [drug products](#b-3-A-i) by [retail distributors](/usc/21/802.md?p=49-A) that may not include face-to-face transactions to the extent that such [distributions](/usc/21/360eee.md?p=5) are consistent with the activities [authorized](/usc/21/360eee–1.md?p=a-6) for a [retail distributor](/usc/21/802.md?p=49-A) as specified in [section 802(49) of this title](/usc/21/802.md?p=49), except that this clause does not apply to sales of [scheduled listed chemical products](/usc/21/802.md?p=45-A) [at retail](/usc/21/802.md?p=48). - (iii) [Distributions](/usc/21/360eee.md?p=5) of [drug products](#b-3-A-i) to a resident of a long term care [facility](/usc/21/350g.md?p=o-2) (as that term is defined in regulations prescribed by the Attorney General) or [distributions](/usc/21/360eee.md?p=5) of [drug products](#b-3-A-i) to a long term care [facility](/usc/21/350g.md?p=o-2) for dispensing to or for use by a resident of that [facility](/usc/21/350g.md?p=o-2). - (iv) [Distributions](/usc/21/360eee.md?p=5) of [drug products](#b-3-A-i) pursuant to a [valid prescription](#b-3-A-ii). - (v) Exports which have been reported to the Attorney General pursuant to section [954](/usc/21/954.md) or [971](/usc/21/971.md) of this title or which are subject to a waiver granted under [section 971(f)(2) of this title](/usc/21/971.md?p=f-2). - (vi) Any quantity, method, or type of [distribution](/usc/21/360eee.md?p=5) or any quantity, method, or type of [distribution](/usc/21/360eee.md?p=5) of a specific [listed chemical](/usc/21/802.md?p=33) (including specific formulations or [drug products](#b-3-A-i)) or of a group of [listed chemicals](/usc/21/802.md?p=33) (including specific formulations or [drug products](#b-3-A-i)) which the Attorney General has excluded by regulation from such reporting requirement on the basis that such reporting is not necessary for the enforcement of this subchapter or subchapter II. - (E) The Attorney General may revoke any or all of the exemptions listed in [subparagraph (D)](#b-3-D) for an individual [regulated person](/usc/21/802.md?p=38) if he finds that [drug products](#b-3-A-i) distributed by the [regulated person](/usc/21/802.md?p=38) are being used in violation of this subchapter or subchapter II. The [regulated person](/usc/21/802.md?p=38) shall be notified of the revocation, which will be effective upon receipt by the [person](/usc/21/379j–21.md?p=k-10) of such notice, as provided in [section 971(c)(1) of this title](/usc/21/971.md?p=c-1), and shall have the right to an expedited hearing as provided in [section 971(c)(2) of this title](/usc/21/971.md?p=c-2). - (c) **Confidentiality of information obtained by Attorney General; non-disclosure; exceptions—** - (1) Except as provided in [paragraph (2)](#c-2), any information obtained by the Attorney General under this section which is exempt from disclosure under [section 552(a) of title 5](/usc/5/552.md?p=a), by reason of [section 552(b)(4)](/usc/5/552.md?p=b-4) of such title, is confidential and may not be disclosed to any [person](/usc/21/379j–21.md?p=k-10). - (2) Information referred to in [paragraph (1)](#c-1) may be disclosed only— - (A) to an officer or employee of the [United States](/usc/21/802.md?p=28) engaged in carrying out this subchapter, subchapter II, or the customs laws; - (B) when relevant in any investigation or proceeding for the enforcement of this subchapter, subchapter II, or the customs laws; - (C) when necessary to comply with an obligation of the [United States](/usc/21/802.md?p=28) under a treaty or other international agreement; or - (D) to a [State](/usc/21/802.md?p=26) or local official or employee in conjunction with the enforcement of [controlled substances](/usc/21/802.md?p=6) laws or chemical [control](/usc/21/802.md?p=5) laws. - (3) The Attorney General shall— - (A) take such action as may be necessary to prevent unauthorized disclosure of information by any [person](/usc/21/379j–21.md?p=k-10) to whom such information is disclosed under [paragraph (2)](#c-2); and - (B) issue guidelines that limit, to the maximum extent feasible, the disclosure of proprietary business information, including the names or identities of [United States](/usc/21/802.md?p=28) exporters of [listed chemicals](/usc/21/802.md?p=33), to any [person](/usc/21/379j–21.md?p=k-10) to whom such information is disclosed under [paragraph (2)](#c-2). - (4) Any [person](/usc/21/379j–21.md?p=k-10) who is aggrieved by a disclosure of information in violation of this section may bring a civil action against the violator for appropriate relief. - (5) Notwithstanding [paragraph (4)](#c-4), a civil action may not be brought under such paragraph against investigative or law enforcement personnel of the [Drug Enforcement Administration](/usc/21/802.md?p=4). - (d) **Scheduled listed chemicals; restrictions on sales quantity; requirements regarding nonliquid forms—** With respect to ephedrine base, pseudoephedrine base, or phenylpropanolamine base in a [scheduled listed chemical product](/usc/21/802.md?p=45-A)— - (1) the quantity of such base sold [at retail](/usc/21/802.md?p=48) in such a product by a [regulated seller](/usc/21/802.md?p=46), or a [distributor](/usc/21/802.md?p=11) required to submit reports by [subsection (b)(3)](#b-3) may not, for any purchaser, exceed a daily amount of 3.6 grams, without regard to the number of transactions; and - (2) such a seller or [distributor](/usc/21/802.md?p=11) may not sell such a product in nonliquid form (including gel caps) [at retail](/usc/21/802.md?p=48) unless the product is packaged in blister packs, each blister containing not more than 2 dosage units, or where the use of blister packs is technically infeasible, the product is packaged in unit dose packets or pouches. - (e) **Scheduled listed chemicals; behind-the-counter access; logbook requirement; training of sales personnel; privacy protections—** - (1) **Requirements regarding retail transactions—** - (A) **In general—** Each [regulated seller](/usc/21/802.md?p=46) shall ensure that, subject to [subparagraph (F)](#e-1-F), sales by such seller of a [scheduled listed chemical product](/usc/21/802.md?p=45-A) [at retail](/usc/21/802.md?p=48) are made in accordance with the following: - (i) In offering the product for sale, the seller places the product such that customers do not have direct access to the product before the sale is made (in this paragraph referred to as “behind-the-counter” placement). For purposes of this paragraph, a behind-the-counter placement of a product includes circumstances in which the product is stored in a locked cabinet that is located in an area of the [facility](/usc/21/350g.md?p=o-2) involved to which customers do have direct access. - (ii) The seller [delivers](/usc/21/802.md?p=8) the product directly into the custody of the purchaser. - (iii) The seller maintains, in accordance with criteria issued by the Attorney General, a written or electronic list of such sales that identifies the products by name, the quantity sold, the names and addresses of purchasers, and the dates and times of the sales (which list is referred to in this subsection as the “logbook”), except that such requirement does not apply to any purchase by an individual of a single sales package if that package contains not more than 60 milligrams of pseudoephedrine. - (iv) In the case of a sale to which the requirement of [clause (iii)](#e-1-A-iii) applies, the seller does not sell such a product unless the sale is made in accordance with the following: - (I) The prospective purchaser— - (aa) presents an identification card that provides a photograph and is issued by a [State](/usc/21/802.md?p=26) or the Federal Government, or a document that, with respect to identification, is considered acceptable for purposes of sections [274a.2(b)(1)(v)(A)](/cfr/8/274a.2.md?p=b-1-v-A) and [274a.2(b)(1)(v)(B)](/cfr/8/274a.2.md?p=b-1-v-B) of title 8, Code of Federal Regulations (as in effect on or after March 9, 2006); and - (bb) signs the written logbook and enters in the logbook his or her name, address, and the date and time of the sale, or for transactions involving an electronic logbook, the purchaser provides a signature using one of the following means: - (AA) Signing a [device](/usc/21/355–2.md?p=a-3) presented by the seller that captures signatures in an electronic format. Such [device](/usc/21/355–2.md?p=a-3) shall display the notice described in [clause (v)](#e-1-A-v). Any [device](/usc/21/355–2.md?p=a-3) used shall preserve each signature in a manner that clearly links that signature to the other electronically-captured logbook information relating to the prospective purchaser providing that signature. - (BB) Signing a bound paper book. Such bound paper book shall include, for such purchaser, either (aaa) a printed sticker affixed to the bound paper book at the time of sale which either displays the name of each product sold, the quantity sold, the name and address of the purchaser, and the date and time of the sale, or a unique identifier which can be linked to that electronic information, or (bbb) a unique identifier which can be linked to that information and which is written into the book by the seller at the time of sale. The purchaser shall sign adjacent to the printed sticker or written unique identifier related to that sale. Such bound paper book shall display the notice described in [clause (v)](#e-1-A-v). - (CC) Signing a printed document that includes, for such purchaser, the name of each product sold, the quantity sold, the name and address of the purchaser, and the date and time of the sale. Such document shall be printed by the seller at the time of the sale. Such document shall contain a clearly identified signature line for a purchaser to sign. Such printed document shall display the notice described in [clause (v)](#e-1-A-v). Each signed document shall be inserted into a binder or other secure means of document storage immediately after the purchaser signs the document. - (II) The seller enters in the logbook the name of the product and the quantity sold. Such information may be captured through electronic means, including through electronic data capture through bar code reader or similar technology. - (III) The logbook maintained by the seller includes the prospective purchaser’s name, address, and the date and time of the sale, as follows: - (aa) If the purchaser enters the information, the seller must determine that the name entered in the logbook corresponds to the name provided on such identification and that the date and time entered are correct. - (bb) If the seller enters the information, the prospective purchaser must [verify](/usc/21/360eee.md?p=28) that the information is correct. - (cc) Such information may be captured through electronic means, including through electronic data capture through bar code reader or similar technology. - (v) The written or electronic logbook includes, in accordance with criteria of the Attorney General, a notice to purchasers that entering false statements or misrepresentations in the logbook, or supplying false information or identification that results in the entry of false statements or misrepresentations, may subject the purchasers to criminal penalties under [section 1001 of title 18](/usc/18/1001.md), which notice specifies the maximum fine and term of imprisonment under such section. - (vi) Regardless of whether the logbook entry is written or electronic, the seller maintains each entry in the logbook for not fewer than 2 years after the date on which the entry is made. - (vii) In the case of individuals who are responsible for delivering such products into the custody of purchasers or who deal directly with purchasers by obtaining payments for the products, the seller has submitted to the Attorney General a self-certification that all such individuals have, in accordance with criteria under [subparagraph (B)(ii)](#e-1-B-ii), undergone training provided by the seller to ensure that the individuals understand the requirements that apply under this subsection and [subsection (d)](#d). - (viii) The seller maintains a copy of such certification and records demonstrating that individuals referred to in [clause (vii)](#e-1-A-vii) have undergone the training. - (ix) If the seller is a [mobile retail vendor](/usc/21/802.md?p=47): - (I) The seller complies with [clause (i)](#e-1-A-i) by placing the product in a locked cabinet. - (II) The seller does not sell more than 7.5 grams of ephedrine base, pseudoephedrine base, or phenylpropanolamine base in such products per customer during a 30-day period. - (B) **Additional provisions regarding certifications and training—** - (i) **In general—** A [regulated seller](/usc/21/802.md?p=46) may not sell any [scheduled listed chemical product](/usc/21/802.md?p=45-A) [at retail](/usc/21/802.md?p=48) unless the seller has submitted to the Attorney General the self-certification referred to in [subparagraph (A)(vii)](#e-1-A-vii). The certification is not effective for purposes of the preceding sentence unless, in addition to provisions regarding the training of individuals referred to in such subparagraph, the certification includes a statement that the seller understands each of the requirements that apply under this paragraph and under [subsection (d)](#d) and agrees to comply with the requirements. - (ii) **Issuance of criteria; self-certification—** The Attorney General shall by regulation establish criteria for certifications under this paragraph. The criteria shall— - (I) provide that the certifications are self-certifications provided through the [program](/usc/21/1523.md?p=8) under [clause (iii)](#e-1-B-iii); - (II) provide that a separate certification is required for each place of business at which a [regulated seller](/usc/21/802.md?p=46) sells [scheduled listed chemical products](/usc/21/802.md?p=45-A) [at retail](/usc/21/802.md?p=48); and - (III) include criteria for training under [subparagraph (A)(vii)](#e-1-A-vii). - (iii) **Program for regulated sellers—** The Attorney General shall establish a [program](/usc/21/1523.md?p=8) regarding such certifications and training in accordance with the following: - (I) The [program](/usc/21/1523.md?p=8) shall be carried out through an [Internet](/usc/21/802.md?p=50) site of the Department of Justice and such other means as the Attorney General determines to be appropriate. - (II) The [program](/usc/21/1523.md?p=8) shall inform [regulated sellers](/usc/21/802.md?p=46) that [section 1001 of title 18](/usc/18/1001.md) applies to such certifications. - (III) The [program](/usc/21/1523.md?p=8) shall make available to such sellers an explanation of the criteria under [clause (ii)](#e-1-B-ii). - (IV) The [program](/usc/21/1523.md?p=8) shall be designed to permit the submission of the certifications through such [Internet](/usc/21/802.md?p=50) site. - (V) The [program](/usc/21/1523.md?p=8) shall be designed to automatically provide the explanation referred to in [subclause (III)](#e-1-B-iii-III), and an acknowledgement that the Department has received a certification, without requiring direct interactions of [regulated sellers](/usc/21/802.md?p=46) with staff of the Department (other than the provision of technical assistance, as appropriate). - (iv) **Availability of certification to State and local officials—** Promptly after receiving a certification under [subparagraph (A)(vii)](#e-1-A-vii), the Attorney General shall make available a copy of the certification to the appropriate [State](/usc/21/802.md?p=26) and local officials. - (v) **Publication of list of self-certified persons—** The Attorney General shall develop and make available a list of all [persons](/usc/21/379j–21.md?p=k-10) who are currently self-certified in accordance with this section. This list shall be made publicly available on the website of the [Drug Enforcement Administration](/usc/21/802.md?p=4) in an electronically downloadable format. - (C) **Privacy protections—** In order to protect the privacy of individuals who purchase [scheduled listed chemical products](/usc/21/802.md?p=45-A), the Attorney General shall by regulation establish restrictions on disclosure of information in logbooks under [subparagraph (A)(iii)](#e-1-A-iii). Such regulations shall— - (i) provide for the disclosure of the information as appropriate to the Attorney General and to [State](/usc/21/802.md?p=26) and local law enforcement agencies; and - (ii) prohibit accessing, using, or sharing information in the logbooks for any purpose other than to ensure compliance with this subchapter or to facilitate a product recall to protect public health and safety. - (D) **False statements or misrepresentations by purchasers—** For purposes of [section 1001 of title 18](/usc/18/1001.md), entering information in the logbook under [subparagraph (A)(iii)](#e-1-A-iii) shall be considered a matter within the jurisdiction of the executive, legislative, or judicial branch of the Government of the [United States](/usc/21/802.md?p=28). - (E) **Good faith protection—** A [regulated seller](/usc/21/802.md?p=46) who in good faith releases information in a logbook under [subparagraph (A)(iii)](#e-1-A-iii) to Federal, [State](/usc/21/802.md?p=26), or local law enforcement authorities is immune from civil liability for such release unless the release constitutes gross negligence or intentional, wanton, or willful misconduct. - (F) **Inapplicability of requirements to certain sales—** [Subparagraph (A)](#e-1-A) does not apply to the sale [at retail](/usc/21/802.md?p=48) of a [scheduled listed chemical product](/usc/21/802.md?p=45-A) if a report on the sales transaction is required to be submitted to the Attorney General under [subsection (b)(3)](#b-3). - (G) **Certain measures regarding theft and diversion—** A [regulated seller](/usc/21/802.md?p=46) may take reasonable measures to guard against employing individuals who may present a risk with respect to the theft and diversion of [scheduled listed chemical products](/usc/21/802.md?p=45-A), which may include, notwithstanding [State](/usc/21/802.md?p=26) law, asking applicants for employment whether they have been convicted of any crime involving or related to such products or [controlled substances](/usc/21/802.md?p=6). - (2) **Mail-order reporting; verification of identity of purchaser; 30-day restriction on quantities for individual purchasers—** Each [regulated person](/usc/21/802.md?p=38) who makes a sale [at retail](/usc/21/802.md?p=48) of a [scheduled listed chemical product](/usc/21/802.md?p=45-A) and is required under [subsection (b)(3)](#b-3) to submit a report of the sales transaction to the Attorney General is subject to the following: - (A) The [person](/usc/21/379j–21.md?p=k-10) shall, prior to shipping the product, confirm the identity of the purchaser in accordance with procedures established by the Attorney General. The Attorney General shall by regulation establish such procedures. - (B) The [person](/usc/21/379j–21.md?p=k-10) may not sell more than 7.5 grams of ephedrine base, pseudoephedrine base, or phenylpropanolamine base in such products per customer during a 30-day period. - (C) Each [regulated person](/usc/21/802.md?p=38) who makes a sale [at retail](/usc/21/802.md?p=48) of a [scheduled listed chemical product](/usc/21/802.md?p=45-A) and is required under [subsection (b)(3)](#b-3) to submit a report of the sales transaction to the Attorney General may not sell any [scheduled listed chemical product](/usc/21/802.md?p=45-A) [at retail](/usc/21/802.md?p=48) unless such [regulated person](/usc/21/802.md?p=38) has submitted to the Attorney General a self-certification including a statement that the seller understands each of the requirements that apply under this paragraph and under [subsection (d)](#d) and agrees to comply with the requirements. The Attorney General shall by regulation establish criteria for certifications of mail-order [distributors](/usc/21/802.md?p=11) that are consistent with the criteria established for the certifications of [regulated sellers](/usc/21/802.md?p=46) under [paragraph (1)(B)](#e-1-B). - (3) **Exemptions for certain products—** Upon the application of a [manufacturer](/usc/21/802.md?p=15) of a [scheduled listed chemical product](/usc/21/802.md?p=45-A), the Attorney General may by regulation provide that the product is exempt from the provisions of [subsection (d)](#d) and paragraphs (1) and (2) of this subsection if the Attorney General determines that the product cannot be used in the illicit [manufacture](/usc/21/802.md?p=15) of methamphetamine. # §831. Additional requirements relating to online pharmacies and telemedicine - (a) **In general—** An [online pharmacy](/usc/21/802.md?p=52) shall display in a visible and clear manner on its [homepage](/usc/21/802.md?p=53) a statement that it complies with the requirements of this section with respect to the [delivery](/usc/21/802.md?p=8) or sale or offer for sale of [controlled substances](/usc/21/802.md?p=6) and shall at all times display on the [homepage](/usc/21/802.md?p=53) of its [Internet](/usc/21/802.md?p=50) site a declaration of compliance in accordance with this section. - (b) **Licensure—** Each [online pharmacy](/usc/21/802.md?p=52) shall comply with the requirements of [State](/usc/21/802.md?p=26) law concerning the licensure of pharmacies in each [State](/usc/21/802.md?p=26) from which it, and in each [State](/usc/21/802.md?p=26) to which it, [delivers](/usc/21/802.md?p=8), [distributes](/usc/21/802.md?p=11), or [dispenses](/usc/21/802.md?p=10) or offers to [deliver](/usc/21/802.md?p=8), [distribute](/usc/21/802.md?p=11), or [dispense](/usc/21/802.md?p=10) [controlled substances](/usc/21/802.md?p=6) by means of the [Internet](/usc/21/802.md?p=50), pursuant to applicable licensure requirements, as determined by each such [State](/usc/21/802.md?p=26). - (c) **Internet pharmacy site disclosure information—** Each [online pharmacy](/usc/21/802.md?p=52) shall post in a visible and clear manner on the [homepage](/usc/21/802.md?p=53) of each [Internet](/usc/21/802.md?p=50) site it operates, or on a page directly linked thereto in which the hyperlink is also visible and clear on the [homepage](/usc/21/802.md?p=53), the following information for each pharmacy that [delivers](/usc/21/802.md?p=8), [distributes](/usc/21/802.md?p=11), or [dispenses](/usc/21/802.md?p=10) [controlled substances](/usc/21/802.md?p=6) pursuant to orders made on, through, or on behalf of, that website: - (1) The name and address of the pharmacy as it appears on the pharmacy’s [Drug Enforcement Administration](/usc/21/802.md?p=4) certificate of registration. - (2) The pharmacy’s telephone number and email address. - (3) The name, professional degree, and [States](/usc/21/802.md?p=26) of licensure of the pharmacist-in-charge, and a telephone number at which the pharmacist-in-charge can be contacted. - (4) A list of the [States](/usc/21/802.md?p=26) in which the pharmacy is [licensed](/usc/21/360eee–1.md?p=a-6) to [dispense](/usc/21/802.md?p=10) [controlled substances](/usc/21/802.md?p=6). - (5) A certification that the pharmacy is registered under this part to [deliver, distribute, or dispense by means of the Internet](/usc/21/802.md?p=51) [controlled substances](/usc/21/802.md?p=6). - (6) The name, address, telephone number, professional degree, and [States](/usc/21/802.md?p=26) of licensure of any [practitioner](/usc/21/802.md?p=21) who has a contractual relationship to provide medical evaluations or issue prescriptions for [controlled substances](/usc/21/802.md?p=6), through referrals from the website or at the request of the owner or operator of the website, or any employee or [agent](/usc/21/802.md?p=3) thereof. - (7) The following statement, unless revised by the Attorney General by regulation: “This [online pharmacy](/usc/21/802.md?p=52) will only [dispense](/usc/21/802.md?p=10) a [controlled substance](/usc/21/802.md?p=6) to a [person](/usc/21/379j–21.md?p=k-10) who has a valid prescription issued for a legitimate medical purpose based upon a medical relationship with a prescribing [practitioner](/usc/21/802.md?p=21). This includes at least one prior in-[person](/usc/21/379j–21.md?p=k-10) medical evaluation or medical evaluation via telemedicine in accordance with applicable requirements of section 309.”. - (d) **Notification—** - (1) **In general—** Thirty days prior to offering a [controlled substance](/usc/21/802.md?p=6) for sale, [delivery](/usc/21/802.md?p=8), [distribution](/usc/21/360eee.md?p=5), or dispensing, the [online pharmacy](/usc/21/802.md?p=52) shall notify the Attorney General, in such form and manner as the Attorney General shall determine, and the [State](/usc/21/802.md?p=26) boards of pharmacy in any [States](/usc/21/802.md?p=26) in which the [online pharmacy](/usc/21/802.md?p=52) offers to sell, [deliver](/usc/21/802.md?p=8), [distribute](/usc/21/802.md?p=11), or [dispense](/usc/21/802.md?p=10) [controlled substances](/usc/21/802.md?p=6). - (2) **Contents—** The notification required under [paragraph (1)](#d-1) shall include— - (A) the information required to be posted on the [online pharmacy](/usc/21/802.md?p=52)’s [Internet](/usc/21/802.md?p=50) site under [subsection (c)](#c) and shall notify the Attorney General and the applicable [State](/usc/21/802.md?p=26) boards of pharmacy, under penalty of perjury, that the information disclosed on its [Internet](/usc/21/802.md?p=50) site under [subsection (c)](#c) is true and accurate; - (B) the [online pharmacy](/usc/21/802.md?p=52)’s [Internet](/usc/21/802.md?p=50) site address and a certification that the [online pharmacy](/usc/21/802.md?p=52) shall notify the Attorney General of any change in the address at least 30 days in advance; and - (C) the [Drug Enforcement Administration](/usc/21/802.md?p=4) registration numbers of any pharmacies and [practitioners](/usc/21/802.md?p=21) referred to in [subsection (c)](#c), as applicable. - (3) **Existing online pharmacies—** An [online pharmacy](/usc/21/802.md?p=52) that is already operational as of the effective date of this section, shall notify the Attorney General and applicable [State](/usc/21/802.md?p=26) boards of pharmacy in accordance with this subsection not later than 30 days after such date. - (e) **Declaration of compliance—** On and after the date on which it makes the notification under [subsection (d)](#d), each [online pharmacy](/usc/21/802.md?p=52) shall display on the [homepage](/usc/21/802.md?p=53) of its [Internet](/usc/21/802.md?p=50) site, in such form as the Attorney General shall by regulation require, a declaration that it has made such notification to the Attorney General. - (f) **Reports—** Any statement, declaration, notification, or disclosure required under this section shall be considered a report required to be kept under this part. - (g) **Notice and designations concerning Indian tribes—** - (1) **In general—** For purposes of sections [802(52)](/usc/21/802.md?p=52) and [882(c)(6)(B)](/usc/21/882.md?p=c-6-B) of this title, the [Secretary](/usc/21/802.md?p=24) shall notify the Attorney General, at such times and in such manner as the [Secretary](/usc/21/802.md?p=24) and the Attorney General determine appropriate, of the Indian tribes or tribal organizations with which the [Secretary](/usc/21/802.md?p=24) has contracted or compacted under the Indian Self-Determination and Education Assistance Act [[25 U.S.C. 5301](/usc/25/5301.md) et seq.] for the tribes or tribal organizations to provide pharmacy services. - (2) **Designations—** - (A) **In general—** The [Secretary](/usc/21/802.md?p=24) may designate a [practitioner](/usc/21/802.md?p=21) described in [subparagraph (B)](#g-2-B) as an [Internet](/usc/21/802.md?p=50) Eligible [Controlled Substances](/usc/21/802.md?p=6) Provider. Such designations shall be made only in cases where the [Secretary](/usc/21/802.md?p=24) has found that there is a legitimate need for the [practitioner](/usc/21/802.md?p=21) to be so designated because the population served by the [practitioner](/usc/21/802.md?p=21) is in a sufficiently remote location that access to medical services is limited. - (B) **Practitioners—** A [practitioner](/usc/21/802.md?p=21) described in this subparagraph is a [practitioner](/usc/21/802.md?p=21) who is an employee or contractor of the Indian Health Service, or is working for an Indian tribe or tribal organization under its contract or compact under the Indian Self-Determination and Education Assistance Act [[25 U.S.C. 5301](/usc/25/5301.md) et seq.] with the Indian Health Service. - (h) **Special registration for telemedicine—** - (1) **In general—** The Attorney General may issue to a [practitioner](/usc/21/802.md?p=21) a special registration to engage in the [practice of telemedicine](/usc/21/802.md?p=54) for purposes of [section 802(54)(E) of this title](/usc/21/802.md?p=54-E) if the [practitioner](/usc/21/802.md?p=21), upon application for such special registration— - (A) demonstrates a legitimate need for the special registration; and - (B) is registered under [section 823(g) of this title](/usc/21/823.md?p=g) in the [State](/usc/21/802.md?p=26) in which the patient will be located when receiving the telemedicine treatment, unless the [practitioner](/usc/21/802.md?p=21)— - (i) is exempted from such registration in all [States](/usc/21/802.md?p=26) under [section 822(d) of this title](/usc/21/822.md?p=d); or - (ii) is an employee or contractor of the Department of Veterans Affairs who is acting in the scope of such employment or contract and is registered under [section 823(g) of this title](/usc/21/823.md?p=g) in any [State](/usc/21/802.md?p=26) or is utilizing the registration of a hospital or clinic operated by the Department of Veterans Affairs registered under [section 823(g) of this title](/usc/21/823.md?p=g). - (2) **Regulations—** Not later than 1 year after October 24, 2018, in consultation with the [Secretary](/usc/21/802.md?p=24), the Attorney General shall promulgate final regulations specifying— - (A) the limited circumstances in which a special registration under this subsection may be issued; and - (B) the procedure for obtaining a special registration under this subsection. - (3) **Denials—** Proceedings to deny an application for registration under this subsection shall be conducted in accordance with [section 824(c) of this title](/usc/21/824.md?p=c). - (i) **Reporting of telemedicine by VHA during medical emergency situations—** - (1) **In general—** Any [practitioner](/usc/21/802.md?p=21) issuing a prescription for a [controlled substance](/usc/21/802.md?p=6) under the authorization to conduct telemedicine during a medical emergency situation described in [section 802(54)(F) of this title](/usc/21/802.md?p=54-F) shall report to the [Secretary](/usc/21/802.md?p=24) of Veterans Affairs the authorization of that emergency prescription, in accordance with such requirements as the [Secretary](/usc/21/802.md?p=24) of Veterans Affairs shall, by regulation, establish. - (2) **To Attorney General—** Not later than 30 days after the date that a prescription described in subparagraph (A) is issued, the [Secretary](/usc/21/802.md?p=24) of Veterans Affairs shall report to the Attorney General the authorization of that emergency prescription. - (j) **Clarification concerning prescription transfers—** Any transfer between pharmacies of information relating to a prescription for a [controlled substance](/usc/21/802.md?p=6) shall meet the applicable requirements under regulations promulgated by the Attorney General under this chapter. # §832. Suspicious orders - (a) **Reporting—** Each registrant shall— - (1) design and operate a system to identify [suspicious orders](/usc/21/802.md?p=57) for the registrant; - (2) ensure that the system designed and operated under [paragraph (1)](#a-1) by the registrant complies with applicable Federal and [State](/usc/21/802.md?p=26) privacy laws; and - (3) upon discovering a [suspicious order](/usc/21/802.md?p=57) or series of orders, notify the [Administrator](/usc/21/1523.md?p=1) of the [Drug Enforcement Administration](/usc/21/802.md?p=4) and the Special [Agent](/usc/21/802.md?p=3) in Charge of the Division [Office](/usc/21/1701.md?p=14) of the [Drug Enforcement Administration](/usc/21/802.md?p=4) for the area in which the registrant is located or conducts business. - (b) **Suspicious order database—** - (1) **In general—** Not later than 1 year after October 24, 2018, the Attorney General shall establish a centralized database for collecting reports of [suspicious orders](/usc/21/802.md?p=57). - (2) **Satisfaction of reporting requirements—** If a registrant reports a [suspicious order](/usc/21/802.md?p=57) to the centralized database established under [paragraph (1)](#b-1), the registrant shall be considered to have complied with the requirement under [subsection (a)(3)](#a-3) to notify the [Administrator](/usc/21/1523.md?p=1) of the [Drug Enforcement Administration](/usc/21/802.md?p=4) and the Special [Agent](/usc/21/802.md?p=3) in Charge of the Division [Office](/usc/21/1701.md?p=14) of the [Drug Enforcement Administration](/usc/21/802.md?p=4) for the area in which the registrant is located or conducts business. - (c) **Sharing information with the States—** - (1) **In general—** The Attorney General shall prepare and make available information regarding [suspicious orders](/usc/21/802.md?p=57) in a [State](/usc/21/802.md?p=26), including information in the database established under [subsection (b)(1)](#b-1), to the point of contact for purposes of administrative, civil, and criminal oversight relating to the diversion of [controlled substances](/usc/21/802.md?p=6) for the [State](/usc/21/802.md?p=26), as designated by the Governor or chief executive officer of the [State](/usc/21/802.md?p=26). - (2) **Timing—** The Attorney General shall provide information in accordance with [paragraph (1)](#c-1) within a reasonable period of time after obtaining the information. - (3) **Coordination—** In establishing the process for the provision of information under this subsection, the Attorney General shall coordinate with [States](/usc/21/802.md?p=26) to ensure that the Attorney General has access to information, as permitted under [State](/usc/21/802.md?p=26) law, possessed by the [States](/usc/21/802.md?p=26) relating to prescriptions for [controlled substances](/usc/21/802.md?p=6) that will assist in enforcing Federal law. # §841. Prohibited acts A - (a) **Unlawful acts—** Except as [authorized](/usc/21/360eee–1.md?p=a-6) by this subchapter, it shall be unlawful for any [person](/usc/21/379j–21.md?p=k-10) knowingly or intentionally— - (1) to [manufacture](/usc/21/802.md?p=15), [distribute](/usc/21/802.md?p=11), or [dispense](/usc/21/802.md?p=10), or possess with intent to [manufacture](/usc/21/802.md?p=15), [distribute](/usc/21/802.md?p=11), or [dispense](/usc/21/802.md?p=10), a [controlled substance](/usc/21/802.md?p=6); or - (2) to create, [distribute](/usc/21/802.md?p=11), or [dispense](/usc/21/802.md?p=10), or possess with intent to [distribute](/usc/21/802.md?p=11) or [dispense](/usc/21/802.md?p=10), a [counterfeit substance](/usc/21/802.md?p=7). - (b) **Penalties—** Except as otherwise provided in section [849](/usc/21/849.md), [859](/usc/21/859.md), [860](/usc/21/860.md), or [861](/usc/21/861.md) of this title, any [person](/usc/21/379j–21.md?p=k-10) who violates [subsection (a)](#a) of this section shall be sentenced as follows: - (1) - (A) In the case of a violation of [subsection (a)](#a) of this section involving— - (i) 1 kilogram or more of a mixture or substance containing a detectable amount of heroin; - (ii) 5 kilograms or more of a mixture or substance containing a detectable amount of— - (I) coca leaves, except coca leaves and extracts of coca leaves from which cocaine, ecgonine, and derivatives of ecgonine or their salts have been removed; - (II) cocaine, its salts, optical and geometric [isomers](/usc/21/802.md?p=14), and salts of [isomers](/usc/21/802.md?p=14); - (III) ecgonine, its derivatives, their salts, [isomers](/usc/21/802.md?p=14), and salts of [isomers](/usc/21/802.md?p=14); or - (IV) any compound, mixture, or preparation which contains any quantity of any of the substances referred to in [subclauses (I) through (III)](#b-1-A-ii-I..b-1-A-ii-III); - (iii) 280 grams or more of a mixture or substance described in [clause (ii)](#b-1-A-ii) which contains cocaine base; - (iv) 100 grams or more of phencyclidine (PCP) or 1 kilogram or more of a mixture or substance containing a detectable amount of phencyclidine (PCP); - (v) 10 grams or more of a mixture or substance containing a detectable amount of lysergic acid diethylamide (LSD); - (vi) 400 grams or more of a mixture or substance containing a detectable amount of N-phenyl-N- [ 1- ( 2-phenylethyl ) -4-piperidinyl ] propanamide or 100 grams or more of a mixture or substance containing a detectable amount of any analogue of N-phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] propanamide or a fentanyl-related substance; - (vii) 1000 kilograms or more of a mixture or substance containing a detectable amount of [marihuana](/usc/21/802.md?p=16-A), or 1,000 or more [marihuana](/usc/21/802.md?p=16-A) plants regardless of weight; or - (viii) 50 grams or more of methamphetamine, its salts, [isomers](/usc/21/802.md?p=14), and salts of its [isomers](/usc/21/802.md?p=14) or 500 grams or more of a mixture or substance containing a detectable amount of methamphetamine, its salts, [isomers](/usc/21/802.md?p=14), or salts of its [isomers](/usc/21/802.md?p=14); such [person](/usc/21/379j–21.md?p=k-10) shall be sentenced to a term of imprisonment which may not be less than 10 years or more than life and if death or [serious bodily injury](/usc/21/802.md?p=25) results from the use of such substance shall be not less than 20 years or more than life, a fine not to exceed the greater of that [authorized](/usc/21/360eee–1.md?p=a-6) in accordance with the provisions of [title 18](/usc/18.md) or $10,000,000 if the defendant is an individual or $50,000,000 if the defendant is other than an individual, or both. If any [person](/usc/21/379j–21.md?p=k-10) commits such a violation after a prior conviction for a [serious drug felony](/usc/21/802.md?p=58) or [serious violent felony](/usc/21/802.md?p=59) has become final, such [person](/usc/21/379j–21.md?p=k-10) shall be sentenced to a term of imprisonment of not less than 15 years and not more than life imprisonment and if death or [serious bodily injury](/usc/21/802.md?p=25) results from the use of such substance shall be sentenced to life imprisonment, a fine not to exceed the greater of twice that [authorized](/usc/21/360eee–1.md?p=a-6) in accordance with the provisions of [title 18](/usc/18.md) or $20,000,000 if the defendant is an individual or $75,000,000 if the defendant is other than an individual, or both. If any [person](/usc/21/379j–21.md?p=k-10) commits a violation of this subparagraph or of section [849](/usc/21/849.md), [859](/usc/21/859.md), [860](/usc/21/860.md), or [861](/usc/21/861.md) of this title after 2 or more prior convictions for a [serious drug felony](/usc/21/802.md?p=58) or [serious violent felony](/usc/21/802.md?p=59) have become final, such [person](/usc/21/379j–21.md?p=k-10) shall be sentenced to a term of imprisonment of not less than 25 years and fined in accordance with the preceding sentence. Notwithstanding [section 3583 of title 18](/usc/18/3583.md), any sentence under this subparagraph shall, in the absence of such a prior conviction, impose a term of supervised release of at least 5 years in addition to such term of imprisonment and shall, if there was such a prior conviction, impose a term of supervised release of at least 10 years in addition to such term of imprisonment. Notwithstanding any other provision of law, the court shall not place on probation or suspend the sentence of any [person](/usc/21/379j–21.md?p=k-10) sentenced under this subparagraph. No [person](/usc/21/379j–21.md?p=k-10) sentenced under this subparagraph shall be eligible for parole during the term of imprisonment imposed therein. - (B) In the case of a violation of [subsection (a)](#a) of this section involving— - (i) 100 grams or more of a mixture or substance containing a detectable amount of heroin; - (ii) 500 grams or more of a mixture or substance containing a detectable amount of— - (I) coca leaves, except coca leaves and extracts of coca leaves from which cocaine, ecgonine, and derivatives of ecgonine or their salts have been removed; - (II) cocaine, its salts, optical and geometric [isomers](/usc/21/802.md?p=14), and salts of [isomers](/usc/21/802.md?p=14); - (III) ecgonine, its derivatives, their salts, [isomers](/usc/21/802.md?p=14), and salts of [isomers](/usc/21/802.md?p=14); or - (IV) any compound, mixture, or preparation which contains any quantity of any of the substances referred to in [subclauses (I) through (III)](#b-1-B-ii-I..b-1-B-ii-III); - (iii) 28 grams or more of a mixture or substance described in [clause (ii)](#b-1-B-ii) which contains cocaine base; - (iv) 10 grams or more of phencyclidine (PCP) or 100 grams or more of a mixture or substance containing a detectable amount of phencyclidine (PCP); - (v) 1 gram or more of a mixture or substance containing a detectable amount of lysergic acid diethylamide (LSD); - (vi) 40 grams or more of a mixture or substance containing a detectable amount of N-phenyl-N- [ 1- ( 2-phenylethyl ) -4-piperidinyl ] propanamide or 10 grams or more of a mixture or substance containing a detectable amount of any analogue of N-phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] propanamide or a fentanyl-related substance; - (vii) 100 kilograms or more of a mixture or substance containing a detectable amount of [marihuana](/usc/21/802.md?p=16-A), or 100 or more [marihuana](/usc/21/802.md?p=16-A) plants regardless of weight; or - (viii) 5 grams or more of methamphetamine, its salts, [isomers](/usc/21/802.md?p=14), and salts of its [isomers](/usc/21/802.md?p=14) or 50 grams or more of a mixture or substance containing a detectable amount of methamphetamine, its salts, [isomers](/usc/21/802.md?p=14), or salts of its [isomers](/usc/21/802.md?p=14); such [person](/usc/21/379j–21.md?p=k-10) shall be sentenced to a term of imprisonment which may not be less than 5 years and not more than 40 years and if death or [serious bodily injury](/usc/21/802.md?p=25) results from the use of such substance shall be not less than 20 years or more than life, a fine not to exceed the greater of that [authorized](/usc/21/360eee–1.md?p=a-6) in accordance with the provisions of [title 18](/usc/18.md) or $5,000,000 if the defendant is an individual or $25,000,000 if the defendant is other than an individual, or both. If any [person](/usc/21/379j–21.md?p=k-10) commits such a violation after a prior conviction for a [serious drug felony](/usc/21/802.md?p=58) or [serious violent felony](/usc/21/802.md?p=59) has become final, such [person](/usc/21/379j–21.md?p=k-10) shall be sentenced to a term of imprisonment which may not be less than 10 years and not more than life imprisonment and if death or [serious bodily injury](/usc/21/802.md?p=25) results from the use of such substance shall be sentenced to life imprisonment, a fine not to exceed the greater of twice that [authorized](/usc/21/360eee–1.md?p=a-6) in accordance with the provisions of [title 18](/usc/18.md) or $8,000,000 if the defendant is an individual or $50,000,000 if the defendant is other than an individual, or both. Notwithstanding [section 3583 of title 18](/usc/18/3583.md), any sentence imposed under this subparagraph shall, in the absence of such a prior conviction, include a term of supervised release of at least 4 years in addition to such term of imprisonment and shall, if there was such a prior conviction, include a term of supervised release of at least 8 years in addition to such term of imprisonment. Notwithstanding any other provision of law, the court shall not place on probation or suspend the sentence of any [person](/usc/21/379j–21.md?p=k-10) sentenced under this subparagraph. No [person](/usc/21/379j–21.md?p=k-10) sentenced under this subparagraph shall be eligible for parole during the term of imprisonment imposed therein. - (C) In the case of a [controlled substance](/usc/21/802.md?p=6) in schedule I or II, gamma hydroxybutyric acid (including when scheduled as an approved [drug product](/usc/21/321.md?p=dd) for purposes of section 3(a)(1)(B) of the Hillory J. Farias and Samantha Reid Date-Rape [Drug](/usc/21/321.md?p=g-1) Prohibition Act of 2000), or 1 gram of flunitrazepam, except as provided in subparagraphs [(A)](#b-1-A), [(B)](#b-1-B), and [(D)](#b-1-D), such [person](/usc/21/379j–21.md?p=k-10) shall be sentenced to a term of imprisonment of not more than 20 years and if death or [serious bodily injury](/usc/21/802.md?p=25) results from the use of such substance shall be sentenced to a term of imprisonment of not less than twenty years or more than life, a fine not to exceed the greater of that [authorized](/usc/21/360eee–1.md?p=a-6) in accordance with the provisions of [title 18](/usc/18.md) or $1,000,000 if the defendant is an individual or $5,000,000 if the defendant is other than an individual, or both. If any [person](/usc/21/379j–21.md?p=k-10) commits such a violation after a prior conviction for a [felony drug offense](/usc/21/802.md?p=44) has become final, such [person](/usc/21/379j–21.md?p=k-10) shall be sentenced to a term of imprisonment of not more than 30 years and if death or [serious bodily injury](/usc/21/802.md?p=25) results from the use of such substance shall be sentenced to life imprisonment, a fine not to exceed the greater of twice that [authorized](/usc/21/360eee–1.md?p=a-6) in accordance with the provisions of [title 18](/usc/18.md) or $2,000,000 if the defendant is an individual or $10,000,000 if the defendant is other than an individual, or both. Notwithstanding [section 3583 of title 18](/usc/18/3583.md), any sentence imposing a term of imprisonment under this paragraph shall, in the absence of such a prior conviction, impose a term of supervised release of at least 3 years in addition to such term of imprisonment and shall, if there was such a prior conviction, impose a term of supervised release of at least 6 years in addition to such term of imprisonment. Notwithstanding any other provision of law, the court shall not place on probation or suspend the sentence of any [person](/usc/21/379j–21.md?p=k-10) sentenced under the provisions of this subparagraph which provide for a mandatory term of imprisonment if death or [serious bodily injury](/usc/21/802.md?p=25) results, nor shall a [person](/usc/21/379j–21.md?p=k-10) so sentenced be eligible for parole during the term of such a sentence. - (D) In the case of less than 50 kilograms of [marihuana](/usc/21/802.md?p=16-A), except in the case of 50 or more [marihuana](/usc/21/802.md?p=16-A) plants regardless of weight, 10 kilograms of hashish, or one kilogram of hashish oil, such [person](/usc/21/379j–21.md?p=k-10) shall, except as provided in paragraphs (4) and (5) of this subsection, be sentenced to a term of imprisonment of not more than 5 years, a fine not to exceed the greater of that [authorized](/usc/21/360eee–1.md?p=a-6) in accordance with the provisions of [title 18](/usc/18.md) or $250,000 if the defendant is an individual or $1,000,000 if the defendant is other than an individual, or both. If any [person](/usc/21/379j–21.md?p=k-10) commits such a violation after a prior conviction for a [felony drug offense](/usc/21/802.md?p=44) has become final, such [person](/usc/21/379j–21.md?p=k-10) shall be sentenced to a term of imprisonment of not more than 10 years, a fine not to exceed the greater of twice that [authorized](/usc/21/360eee–1.md?p=a-6) in accordance with the provisions of [title 18](/usc/18.md) or $500,000 if the defendant is an individual or $2,000,000 if the defendant is other than an individual, or both. Notwithstanding [section 3583 of title 18](/usc/18/3583.md), any sentence imposing a term of imprisonment under this paragraph shall, in the absence of such a prior conviction, impose a term of supervised release of at least 2 years in addition to such term of imprisonment and shall, if there was such a prior conviction, impose a term of supervised release of at least 4 years in addition to such term of imprisonment. - (E) - (i) Except as provided in subparagraphs [(C)](#b-1-C) and [(D)](#b-1-D), in the case of any [controlled substance](/usc/21/802.md?p=6) in schedule III, such [person](/usc/21/379j–21.md?p=k-10) shall be sentenced to a term of imprisonment of not more than 10 years and if death or [serious bodily injury](/usc/21/802.md?p=25) results from the use of such substance shall be sentenced to a term of imprisonment of not more than 15 years, a fine not to exceed the greater of that [authorized](/usc/21/360eee–1.md?p=a-6) in accordance with the provisions of [title 18](/usc/18.md) or $500,000 if the defendant is an individual or $2,500,000 if the defendant is other than an individual, or both. - (ii) If any [person](/usc/21/379j–21.md?p=k-10) commits such a violation after a prior conviction for a [felony drug offense](/usc/21/802.md?p=44) has become final, such [person](/usc/21/379j–21.md?p=k-10) shall be sentenced to a term of imprisonment of not more than 20 years and if death or [serious bodily injury](/usc/21/802.md?p=25) results from the use of such substance shall be sentenced to a term of imprisonment of not more than 30 years, a fine not to exceed the greater of twice that [authorized](/usc/21/360eee–1.md?p=a-6) in accordance with the provisions of [title 18](/usc/18.md) or $1,000,000 if the defendant is an individual or $5,000,000 if the defendant is other than an individual, or both. - (iii) Any sentence imposing a term of imprisonment under this subparagraph shall, in the absence of such a prior conviction, impose a term of supervised release of at least 2 years in addition to such term of imprisonment and shall, if there was such a prior conviction, impose a term of supervised release of at least 4 years in addition to such term of imprisonment. - (2) In the case of a [controlled substance](/usc/21/802.md?p=6) in schedule IV, such [person](/usc/21/379j–21.md?p=k-10) shall be sentenced to a term of imprisonment of not more than 5 years, a fine not to exceed the greater of that [authorized](/usc/21/360eee–1.md?p=a-6) in accordance with the provisions of [title 18](/usc/18.md) or $250,000 if the defendant is an individual or $1,000,000 if the defendant is other than an individual, or both. If any [person](/usc/21/379j–21.md?p=k-10) commits such a violation after a prior conviction for a [felony drug offense](/usc/21/802.md?p=44) has become final, such [person](/usc/21/379j–21.md?p=k-10) shall be sentenced to a term of imprisonment of not more than 10 years, a fine not to exceed the greater of twice that [authorized](/usc/21/360eee–1.md?p=a-6) in accordance with the provisions of [title 18](/usc/18.md) or $500,000 if the defendant is an individual or $2,000,000 if the defendant is other than an individual, or both. Any sentence imposing a term of imprisonment under this paragraph shall, in the absence of such a prior conviction, impose a term of supervised release of at least one year in addition to such term of imprisonment and shall, if there was such a prior conviction, impose a term of supervised release of at least 2 years in addition to such term of imprisonment. - (3) In the case of a [controlled substance](/usc/21/802.md?p=6) in schedule V, such [person](/usc/21/379j–21.md?p=k-10) shall be sentenced to a term of imprisonment of not more than one year, a fine not to exceed the greater of that [authorized](/usc/21/360eee–1.md?p=a-6) in accordance with the provisions of [title 18](/usc/18.md) or $100,000 if the defendant is an individual or $250,000 if the defendant is other than an individual, or both. If any [person](/usc/21/379j–21.md?p=k-10) commits such a violation after a prior conviction for a [felony drug offense](/usc/21/802.md?p=44) has become final, such [person](/usc/21/379j–21.md?p=k-10) shall be sentenced to a term of imprisonment of not more than 4 years, a fine not to exceed the greater of twice that [authorized](/usc/21/360eee–1.md?p=a-6) in accordance with the provisions of [title 18](/usc/18.md) or $200,000 if the defendant is an individual or $500,000 if the defendant is other than an individual, or both. Any sentence imposing a term of imprisonment under this paragraph may, if there was a prior conviction, impose a term of supervised release of not more than 1 year, in addition to such term of imprisonment. - (4) Notwithstanding paragraph (1)(D) of this subsection, any [person](/usc/21/379j–21.md?p=k-10) who violates [subsection (a)](#a) of this section by distributing a small amount of [marihuana](/usc/21/802.md?p=16-A) for no remuneration shall be treated as provided in [section 844 of this title](/usc/21/844.md) and [section 3607 of title 18](/usc/18/3607.md). - (5) Any [person](/usc/21/379j–21.md?p=k-10) who violates [subsection (a)](#a) of this section by cultivating or manufacturing a [controlled substance](/usc/21/802.md?p=6) on Federal property shall be imprisoned as provided in this subsection and shall be fined any amount not to exceed— - (A) the amount [authorized](/usc/21/360eee–1.md?p=a-6) in accordance with this section; - (B) the amount [authorized](/usc/21/360eee–1.md?p=a-6) in accordance with the provisions of [title 18](/usc/18.md); - (C) $500,000 if the defendant is an individual; or - (D) $1,000,000 if the defendant is other than an individual; or both. - (6) Any [person](/usc/21/379j–21.md?p=k-10) who violates [subsection (a)](#a), or attempts to do so, and knowingly or intentionally uses a poison, chemical, or other hazardous substance on Federal land, and, by such use— - (A) creates a serious hazard to humans, wildlife, or domestic animals, - (B) degrades or harms the environment or natural resources, or - (C) pollutes an aquifer, spring, stream, river, or body of water, shall be fined in accordance with [title 18](/usc/18.md) or imprisoned not more than five years, or both. - (7) **Penalties for distribution.—** - (A) **In general.—** Whoever, with intent to commit a crime of violence, as defined in [section 16 of title 18](/usc/18/16.md) (including rape), against an individual, violates [subsection (a)](#a) by distributing a [controlled substance](/usc/21/802.md?p=6) or [controlled substance analogue](/usc/21/802.md?p=32-A) to that individual [without that individual](#b-7-B)’s knowledge, shall be imprisoned not more than 20 years and fined in accordance with [title 18](/usc/18.md). - (B) **Definition.—** For purposes of this paragraph, the term “without that individual’s knowledge” means that the individual is unaware that a substance with the ability to alter that individual’s ability to appraise conduct or to decline participation in or communicate unwillingness to participate in conduct is administered to the individual. - (c) **Offenses involving listed chemicals—** Any [person](/usc/21/379j–21.md?p=k-10) who knowingly or intentionally— - (1) possesses a [listed chemical](/usc/21/802.md?p=33) with intent to [manufacture](/usc/21/802.md?p=15) a [controlled substance](/usc/21/802.md?p=6) except as [authorized](/usc/21/360eee–1.md?p=a-6) by this subchapter; - (2) possesses or [distributes](/usc/21/802.md?p=11) a [listed chemical](/usc/21/802.md?p=33) knowing, or having reasonable cause to believe, that the [listed chemical](/usc/21/802.md?p=33) will be used to [manufacture](/usc/21/802.md?p=15) a [controlled substance](/usc/21/802.md?p=6) except as [authorized](/usc/21/360eee–1.md?p=a-6) by this subchapter; or - (3) with the intent of causing the evasion of the recordkeeping or reporting requirements of [section 830 of this title](/usc/21/830.md), or the regulations issued under that section, receives or [distributes](/usc/21/802.md?p=11) a reportable amount of any [listed chemical](/usc/21/802.md?p=33) in units small enough so that the making of records or filing of reports under that section is not required; shall be fined in accordance with [title 18](/usc/18.md) or imprisoned not more than 20 years in the case of a violation of paragraph [(1)](#c-1) or [(2)](#c-2) involving a [list I chemical](/usc/21/802.md?p=34) or not more than 10 years in the case of a violation of this subsection other than a violation of paragraph [(1)](#c-1) or [(2)](#c-2) involving a [list I chemical](/usc/21/802.md?p=34), or both. - (d) **Boobytraps on Federal property; penalties; “boobytrap” defined—** - (1) Any [person](/usc/21/379j–21.md?p=k-10) who assembles, maintains, places, or causes to be placed a [boobytrap](#d-3) on Federal property where a [controlled substance](/usc/21/802.md?p=6) is being manufactured, distributed, or dispensed shall be sentenced to a term of imprisonment for not more than 10 years or fined under [title 18](/usc/18.md), or both. - (2) If any [person](/usc/21/379j–21.md?p=k-10) commits such a violation after 1 or more prior convictions for an offense punishable under this subsection, such [person](/usc/21/379j–21.md?p=k-10) shall be sentenced to a term of imprisonment of not more than 20 years or fined under [title 18](/usc/18.md), or both. - (3) For the purposes of this subsection, the term “boobytrap” means any concealed or camouflaged [device](/usc/21/355–2.md?p=a-3) designed to cause bodily injury when triggered by any action of any unsuspecting [person](/usc/21/379j–21.md?p=k-10) making contact with the [device](/usc/21/355–2.md?p=a-3). Such term includes guns, ammunition, or explosive [devices](/usc/21/355–2.md?p=a-3) attached to trip wires or other triggering mechanisms, sharpened stakes, and lines or wires with hooks attached. - (e) **Ten-year injunction as additional penalty—** In addition to any other applicable penalty, any [person](/usc/21/379j–21.md?p=k-10) convicted of a [felony](/usc/21/802.md?p=13) violation of this section relating to the receipt, [distribution](/usc/21/360eee.md?p=5), [manufacture](/usc/21/802.md?p=15), exportation, or importation of a [listed chemical](/usc/21/802.md?p=33) may be enjoined from engaging in any transaction involving a [listed chemical](/usc/21/802.md?p=33) for not more than ten years. - (f) **Wrongful distribution or possession of listed chemicals—** - (1) Whoever knowingly [distributes](/usc/21/802.md?p=11) a [listed chemical](/usc/21/802.md?p=33) in violation of this subchapter (other than in violation of a recordkeeping or reporting requirement of [section 830 of this title](/usc/21/830.md)) shall, except to the extent that paragraph (12), (13), or (14) of [section 842(a) of this title](/usc/21/842.md?p=a) applies, be fined under [title 18](/usc/18.md) or imprisoned not more than 5 years, or both. - (2) Whoever possesses any [listed chemical](/usc/21/802.md?p=33), with knowledge that the recordkeeping or reporting requirements of [section 830 of this title](/usc/21/830.md) have not been adhered to, if, after such knowledge is acquired, such [person](/usc/21/379j–21.md?p=k-10) does not take immediate steps to remedy the violation shall be fined under [title 18](/usc/18.md) or imprisoned not more than one year, or both. - (g) **Internet sales of date rape drugs—** - (1) Whoever knowingly uses the [Internet](/usc/21/802.md?p=50) to [distribute](/usc/21/802.md?p=11) a [date rape drug](#g-2-A) to any [person](/usc/21/379j–21.md?p=k-10), knowing or with reasonable cause to believe that— - (A) the [drug](/usc/21/321.md?p=g-1) would be used in the commission of criminal sexual conduct; or - (B) the [person](/usc/21/379j–21.md?p=k-10) is not an [authorized purchaser](#g-2-B); shall be fined under this subchapter or imprisoned not more than 20 years, or both. - (2) As used in this subsection: - (A) The term “date rape drug” means— - (i) gamma hydroxybutyric acid (GHB) or any [controlled substance analogue](/usc/21/802.md?p=32-A) of GHB, including gamma butyrolactone (GBL) or 1,4–butanediol; - (ii) ketamine; - (iii) flunitrazepam; or - (iv) any substance which the Attorney General designates, pursuant to the rulemaking procedures prescribed by [section 553 of title 5](/usc/5/553.md), to be used in committing rape or sexual assault. The Attorney General is [authorized](/usc/21/360eee–1.md?p=a-6) to remove any substance from the list of date rape drugs pursuant to the same rulemaking authority. - (B) The term “authorized purchaser” means any of the following [persons](/usc/21/379j–21.md?p=k-10), provided such [person](/usc/21/379j–21.md?p=k-10) has acquired the [controlled substance](/usc/21/802.md?p=6) in accordance with this chapter: - (i) A [person](/usc/21/379j–21.md?p=k-10) with a valid prescription that is issued for a legitimate medical purpose in the usual course of professional practice that is based upon a qualifying medical relationship by a [practitioner](/usc/21/802.md?p=21) registered by the Attorney General. A “qualifying medical relationship” means a medical relationship that exists when the [practitioner](/usc/21/802.md?p=21) has conducted at least 1 medical evaluation with the [authorized purchaser](#g-2-B) in the physical presence of the [practitioner](/usc/21/802.md?p=21), without regard to whether portions of the evaluation are conducted by other heath[^1] professionals. The preceding sentence shall not be construed to imply that 1 medical evaluation demonstrates that a prescription has been issued for a legitimate medical purpose within the usual course of professional practice. - (ii) Any [practitioner](/usc/21/802.md?p=21) or other registrant who is otherwise [authorized](/usc/21/360eee–1.md?p=a-6) by their registration to [dispense](/usc/21/802.md?p=10), procure, purchase, [manufacture](/usc/21/802.md?p=15), transfer, [distribute](/usc/21/802.md?p=11), import, or export the substance under this chapter. - (iii) A [person](/usc/21/379j–21.md?p=k-10) or entity providing documentation that establishes the name, address, and business of the [person](/usc/21/379j–21.md?p=k-10) or entity and which provides a legitimate purpose for using any “[date rape drug](#g-2-A)” for which a prescription is not required. - (3) The Attorney General is [authorized](/usc/21/360eee–1.md?p=a-6) to promulgate regulations for record-keeping and reporting by [persons](/usc/21/379j–21.md?p=k-10) handling 1,4–butanediol in order to implement and enforce the provisions of this section. Any record or report required by such regulations shall be considered a record or report required under this chapter. - (h) **Offenses involving dispensing of controlled substances by means of the Internet—** - (1) **In general—** It shall be unlawful for any [person](/usc/21/379j–21.md?p=k-10) to knowingly or intentionally— - (A) [deliver](/usc/21/802.md?p=8), [distribute](/usc/21/802.md?p=11), or [dispense](/usc/21/802.md?p=10) a [controlled substance](/usc/21/802.md?p=6) by means of the [Internet](/usc/21/802.md?p=50), except as [authorized](/usc/21/360eee–1.md?p=a-6) by this subchapter; or - (B) aid or abet (as such terms are used in [section 2 of title 18](/usc/18/2.md)) any activity described in [subparagraph (A)](#h-1-A) that is not [authorized](/usc/21/360eee–1.md?p=a-6) by this subchapter. - (2) **Examples—** Examples of activities that violate [paragraph (1)](#h-1) include, but are not limited to, knowingly or intentionally— - (A) delivering, distributing, or dispensing a [controlled substance](/usc/21/802.md?p=6) by means of the [Internet](/usc/21/802.md?p=50) by an [online pharmacy](/usc/21/802.md?p=52) that is not validly registered with a modification authorizing such activity as required by [section 823(g) of this title](/usc/21/823.md?p=g) (unless exempt from such registration); - (B) writing a prescription for a [controlled substance](/usc/21/802.md?p=6) for the purpose of [delivery](/usc/21/802.md?p=8), [distribution](/usc/21/360eee.md?p=5), or dispensation by means of the [Internet](/usc/21/802.md?p=50) in violation of [section 829(e) of this title](/usc/21/829.md?p=e); - (C) serving as an [agent](/usc/21/802.md?p=3), intermediary, or other entity that causes the [Internet](/usc/21/802.md?p=50) to be used to bring together a buyer and seller to engage in the dispensing of a [controlled substance](/usc/21/802.md?p=6) in a manner not [authorized](/usc/21/360eee–1.md?p=a-6) by sections[^2] 823(g) or 829(e) of this title; - (D) offering to fill a prescription for a [controlled substance](/usc/21/802.md?p=6) based solely on a consumer’s completion of an online medical questionnaire; and - (E) making a material false, fictitious, or fraudulent statement or representation in a notification or declaration under subsection [(d)](#d) or [(e)](#e), respectively, of [section 831 of this title](/usc/21/831.md). - (3) **Inapplicability—** - (A) This subsection does not apply to— - (i) the [delivery](/usc/21/802.md?p=8), [distribution](/usc/21/360eee.md?p=5), or dispensation of [controlled substances](/usc/21/802.md?p=6) by nonpractitioners to the extent [authorized](/usc/21/360eee–1.md?p=a-6) by their registration under this subchapter; - (ii) the placement on the [Internet](/usc/21/802.md?p=50) of material that merely advocates the use of a [controlled substance](/usc/21/802.md?p=6) or includes pricing information without attempting to propose or facilitate an actual transaction involving a [controlled substance](/usc/21/802.md?p=6); or - (iii) except as provided in [subparagraph (B)](#h-3-B), any activity that is limited to— - (I) the provision of a telecommunications service, or of an [Internet](/usc/21/802.md?p=50) access service or [Internet](/usc/21/802.md?p=50) information location tool (as those terms are defined in [section 231 of title 47](/usc/47/231.md)); or - (II) the transmission, storage, retrieval, hosting, formatting, or translation (or any combination thereof) of a communication, without selection or alteration of the content of the communication, except that deletion of a particular communication or material made by another [person](/usc/21/379j–21.md?p=k-10) in a manner consistent with [section 230(c) of title 47](/usc/47/230.md?p=c) shall not constitute such selection or alteration of the content of the communication. - (B) The exceptions under subclauses [(I)](#h-3-A-iii-I) and [(II)](#h-3-A-iii-II) of subparagraph (A)(iii) shall not apply to a [person](/usc/21/379j–21.md?p=k-10) acting in concert with a [person](/usc/21/379j–21.md?p=k-10) who violates [paragraph (1)](#h-1). - (4) **Knowing or intentional violation—** Any [person](/usc/21/379j–21.md?p=k-10) who knowingly or intentionally violates this subsection shall be sentenced in accordance with [subsection (b)](#b). # §842. Prohibited acts B - (a) **Unlawful acts—** It shall be unlawful for any [person](/usc/21/379j–21.md?p=k-10)— - (1) who is subject to the requirements of part C to [distribute](/usc/21/802.md?p=11) or [dispense](/usc/21/802.md?p=10) a [controlled substance](/usc/21/802.md?p=6) in violation of [section 829 of this title](/usc/21/829.md); - (2) who is a registrant to [distribute](/usc/21/802.md?p=11) or [dispense](/usc/21/802.md?p=10) a [controlled substance](/usc/21/802.md?p=6) not [authorized](/usc/21/360eee–1.md?p=a-6) by his registration to another registrant or other [authorized](/usc/21/360eee–1.md?p=a-6) [person](/usc/21/379j–21.md?p=k-10) or to [manufacture](/usc/21/802.md?p=15) a [controlled substance](/usc/21/802.md?p=6) not [authorized](/usc/21/360eee–1.md?p=a-6) by his registration; - (3) who is a registrant to [distribute](/usc/21/802.md?p=11) a [controlled substance](/usc/21/802.md?p=6) in violation of [section 825 of this title](/usc/21/825.md); - (4) to remove, alter, or obliterate a symbol or label required by [section 825 of this title](/usc/21/825.md); - (5) to refuse or negligently fail to make, keep, or furnish any record, report, notification, declaration, order or order form, statement, invoice, or information required under this subchapter or subchapter II; - (6) to refuse any entry into any premises or inspection [authorized](/usc/21/360eee–1.md?p=a-6) by this subchapter or subchapter II; - (7) to remove, break, injure, or deface a seal placed upon [controlled substances](/usc/21/802.md?p=6) pursuant to section [824(f)](/usc/21/824.md?p=f) or [881](/usc/21/881.md) of this title or to remove or dispose of substances so placed under seal; - (8) to use, to his own advantage, or to reveal, other than to duly [authorized](/usc/21/360eee–1.md?p=a-6) officers or employees of the [United States](/usc/21/802.md?p=28), or to the courts when relevant in any judicial proceeding under this subchapter or subchapter II, any information acquired in the course of an inspection [authorized](/usc/21/360eee–1.md?p=a-6) by this subchapter concerning any method or process which as a trade secret is entitled to protection, or to use to his own advantage or reveal (other than as [authorized](/usc/21/360eee–1.md?p=a-6) by [section 830 of this title](/usc/21/830.md)) any information that is confidential under such section; - (9) who is a [regulated person](/usc/21/802.md?p=38) to engage in a [regulated transaction](/usc/21/802.md?p=39) without obtaining the identification required by 830(a)(3) of this title.[^1] - (10) negligently to fail to keep a record or make a report under [section 830 of this title](/usc/21/830.md) or negligently to fail to self-certify as required under [section 830 of this title](/usc/21/830.md); - (11) to [distribute](/usc/21/802.md?p=11) a [laboratory supply](#a) to a [person](/usc/21/379j–21.md?p=k-10) who uses, or attempts to use, that [laboratory supply](#a) to [manufacture](/usc/21/802.md?p=15) a [controlled substance](/usc/21/802.md?p=6) or a [listed chemical](/usc/21/802.md?p=33), in violation of this subchapter or subchapter II, with reckless disregard for the illegal uses to which such a [laboratory supply](#a) will be put; - (12) who is a [regulated seller](/usc/21/802.md?p=46), or a [distributor](/usc/21/802.md?p=11) required to submit reports under subsection (b)(3) of [section 830 of this title](/usc/21/830.md)— - (A) to sell [at retail](/usc/21/802.md?p=48) a [scheduled listed chemical product](/usc/21/802.md?p=45-A) in violation of paragraph (1) of subsection (d) of such section, knowing at the time of the transaction involved (independent of consulting the logbook under subsection (e)(1)(A)(iii) of such section) that the transaction is a violation; or - (B) to knowingly or recklessly sell [at retail](/usc/21/802.md?p=48) such a product in violation of [paragraph (2)](#a-2) of such subsection (d); - (13) who is a [regulated seller](/usc/21/802.md?p=46) to knowingly or recklessly sell [at retail](/usc/21/802.md?p=48) a [scheduled listed chemical product](/usc/21/802.md?p=45-A) in violation of subsection (e) of such section; - (14) who is a [regulated seller](/usc/21/802.md?p=46) or an employee or [agent](/usc/21/802.md?p=3) of such seller to disclose, in violation of regulations under subparagraph (C) of [section 830(e)(1) of this title](/usc/21/830.md?p=e-1), information in logbooks under [subparagraph (A)(iii)](/usc/21/830.md?p=e-1-A-iii) of such section, or to refuse to provide such a logbook to Federal, [State](/usc/21/802.md?p=26), or local law enforcement authorities; - (15) to [distribute](/usc/21/802.md?p=11) a [scheduled listed chemical product](/usc/21/802.md?p=45-A) to a [regulated seller](/usc/21/802.md?p=46), or to a [regulated person](/usc/21/802.md?p=38) referred to in [section 830(b)(3)(B) of this title](/usc/21/830.md?p=b-3-B), unless such [regulated seller](/usc/21/802.md?p=46) or [regulated person](/usc/21/802.md?p=38) is, at the time of such [distribution](/usc/21/360eee.md?p=5), currently registered with the [Drug Enforcement Administration](/usc/21/802.md?p=4), or on the list of [persons](/usc/21/379j–21.md?p=k-10) referred to under [section 830(e)(1)(B)(v) of this title](/usc/21/830.md?p=e-1-B-v); - (16) to violate subsection (e) of [section 825 of this title](/usc/21/825.md);[^2] or - (17) in the case of a registered [manufacturer](/usc/21/802.md?p=15) or [distributor](/usc/21/802.md?p=11) of [opioids](/usc/21/802.md?p=18), to fail to review the most recent information, directly related to the customers of the [manufacturer](/usc/21/802.md?p=15) or [distributor](/usc/21/802.md?p=11), made available by the Attorney General in accordance with [section 827(f) of this title](/usc/21/827.md?p=f). As used in [paragraph (11)](#a-11), the term “laboratory supply” means a [listed chemical](/usc/21/802.md?p=33) or any chemical, substance, or item on a special surveillance list published by the Attorney General, which contains chemicals, products, materials, or equipment used in the [manufacture](/usc/21/802.md?p=15) of [controlled substances](/usc/21/802.md?p=6) and [listed chemicals](/usc/21/802.md?p=33). For purposes of [paragraph (11)](#a-11), there is a rebuttable presumption of reckless disregard at trial if the Attorney General notifies a firm in writing that a laboratory supply sold by the firm, or any other [person](/usc/21/379j–21.md?p=k-10) or firm, has been used by a customer of the notified firm, or distributed further by that customer, for the unlawful [production](/usc/21/802.md?p=22) of [controlled substances](/usc/21/802.md?p=6) or [listed chemicals](/usc/21/802.md?p=33) a firm [distributes](/usc/21/802.md?p=11) and 2 weeks or more after the notification the notified firm [distributes](/usc/21/802.md?p=11) a laboratory supply to the customer. For purposes of [paragraph (15)](#a-15), if the [distributor](/usc/21/802.md?p=11) is temporarily unable to access the list of [persons](/usc/21/379j–21.md?p=k-10) referred to under [section 830(e)(1)(B)(v) of this title](/usc/21/830.md?p=e-1-B-v), the [distributor](/usc/21/802.md?p=11) may rely on a written, faxed, or electronic copy of a certificate of self-certification submitted by the [regulated seller](/usc/21/802.md?p=46) or [regulated person](/usc/21/802.md?p=38), provided the [distributor](/usc/21/802.md?p=11) confirms within 7 business days of the [distribution](/usc/21/360eee.md?p=5) that such [regulated seller](/usc/21/802.md?p=46) or [regulated person](/usc/21/802.md?p=38) is on the list referred to under [section 830(e)(1)(B)(v) of this title](/usc/21/830.md?p=e-1-B-v). - (b) **Manufacture—** It shall be unlawful for any [person](/usc/21/379j–21.md?p=k-10) who is a registrant to [manufacture](/usc/21/802.md?p=15) a [controlled substance](/usc/21/802.md?p=6) in schedule I or II, or ephedrine, pseudoephedrine, or phenylpropanolamine or any of the salts, optical [isomers](/usc/21/802.md?p=14), or salts of optical [isomers](/usc/21/802.md?p=14) of such chemical, which is— - (1) not expressly [authorized](/usc/21/360eee–1.md?p=a-6) by his registration and by a quota assigned to him pursuant to [section 826 of this title](/usc/21/826.md); or - (2) in excess of a quota assigned to him pursuant to [section 826 of this title](/usc/21/826.md). - (c) **Penalties—** - (1) - (A) Except as provided in subparagraph (B), (C), or (D) of this paragraph and [paragraph (2)](#c-2), any [person](/usc/21/379j–21.md?p=k-10) who violates this section shall, with respect to any such violation, be subject to a civil penalty of not more than $25,000. The district courts of the [United States](/usc/21/802.md?p=28) (or, where there is no such court in the case of any [territory](/usc/21/387.md?p=19) or possession of the [United States](/usc/21/802.md?p=28), then the court in such [territory](/usc/21/387.md?p=19) or possession having the jurisdiction of a district court of the [United States](/usc/21/802.md?p=28) in cases arising under the Constitution and laws of the [United States](/usc/21/802.md?p=28)) shall have jurisdiction in accordance with [section 1355 of title 28](/usc/28/1355.md) to enforce this paragraph. - (B) - (i) Except as provided in [clause (ii)](#c-1-B-ii), in the case of a violation of paragraph [(5)](#a-5), [(10)](#a-10), or [(17)](#a-17) of subsection (a), the civil penalty shall not exceed $10,000. - (ii) In the case of a violation described in [clause (i)](#c-1-B-i) committed by a registered [manufacturer](/usc/21/802.md?p=15) or [distributor](/usc/21/802.md?p=11) of [opioids](/usc/21/802.md?p=18) and related to the reporting of [suspicious orders](/usc/21/802.md?p=57) for [opioids](/usc/21/802.md?p=18), failing to maintain effective [controls](/usc/21/802.md?p=5) against diversion of [opioids](/usc/21/802.md?p=18), or failing to review the most recent information made available by the Attorney General in accordance with [section 827(f) of this title](/usc/21/827.md?p=f), the penalty shall not exceed $100,000. - (C) In the case of a violation of [paragraph (16)](#a-16) of subsection (a) of this section by an importer, exporter, [manufacturer](/usc/21/802.md?p=15), or [distributor](/usc/21/802.md?p=11) (other than as provided in [subparagraph (D)](#c-1-D)), up to $500,000 per violation. For purposes of this subparagraph, a violation is defined as each instance of importation, exportation, manufacturing, [distribution](/usc/21/360eee.md?p=5), or possession with intent to [manufacture](/usc/21/802.md?p=15) or [distribute](/usc/21/802.md?p=11), in violation of [paragraph (16)](#a-16) of subsection (a). - (D) In the case of a [distribution](/usc/21/360eee.md?p=5), dispensing, or possession with intent to [distribute](/usc/21/802.md?p=11) or [dispense](/usc/21/802.md?p=10) in violation of [paragraph (16)](#a-16) of subsection (a) of this section at the retail level, up to $1000 per violation. For purposes of this paragraph, the term “at the retail level” refers to products sold, or held for sale, directly to the consumer for personal use. Each package, container or other separate unit containing an [anabolic steroid](/usc/21/802.md?p=41-A) that is distributed, dispensed, or possessed with intent to [distribute](/usc/21/802.md?p=11) or [dispense](/usc/21/802.md?p=10) at the retail level in violation of such [paragraph (16)](#a-16) of subsection (a) shall be considered a separate violation. - (2) - (A) If a violation of this section is prosecuted by an information or indictment which alleges that the violation was committed knowingly and the trier of fact specifically finds that the violation was so committed, such [person](/usc/21/379j–21.md?p=k-10) shall, except as otherwise provided in subparagraph (B) or (D) of this paragraph, be sentenced to imprisonment of not more than one year or a fine under [title 18](/usc/18.md), or both. - (B) If a violation referred to in [subparagraph (A)](#c-2-A) was committed after one or more prior convictions of the offender for an offense punishable under this [paragraph (2)](#c-2), or for a crime under any other provision of this subchapter or subchapter II or other law of the [United States](/usc/21/802.md?p=28) relating to [narcotic drugs](/usc/21/802.md?p=17), [marihuana](/usc/21/802.md?p=16-A), or [depressant or stimulant substances](/usc/21/802.md?p=9), have become final, such [person](/usc/21/379j–21.md?p=k-10) shall be sentenced to a term of imprisonment of not more than 2 years, a fine under [title 18](/usc/18.md), or both. - (C) In addition to the penalties set forth elsewhere in this subchapter or subchapter II, any business that violates [paragraph (11)](#a-11) of subsection (a) shall, with respect to the first such violation, be subject to a civil penalty of not more than $250,000, but shall not be subject to criminal penalties under this section, and shall, for any succeeding violation, be subject to a civil fine of not more than $250,000 or double the last previously imposed penalty, whichever is greater. - (D) In the case of a violation described in [subparagraph (A)](#c-2-A) that was a violation of paragraph [(5)](#a-5), [(10)](#a-10), or [(17)](#a-17) of subsection (a) committed by a registered [manufacturer](/usc/21/802.md?p=15) or [distributor](/usc/21/802.md?p=11) of [opioids](/usc/21/802.md?p=18) that relates to the reporting of [suspicious orders](/usc/21/802.md?p=57) for [opioids](/usc/21/802.md?p=18), failing to maintain effective [controls](/usc/21/802.md?p=5) against diversion of [opioids](/usc/21/802.md?p=18), or failing to review the most recent information made available by the Attorney General in accordance with [section 827(f) of this title](/usc/21/827.md?p=f), the criminal fine under [title 18](/usc/18.md) shall not exceed $500,000. - (3) Except under the conditions specified in paragraph (2) of this subsection, a violation of this section does not constitute a crime, and a judgment for the [United States](/usc/21/802.md?p=28) and imposition of a civil penalty pursuant to [paragraph (1)](#c-1) shall not give rise to any disability or legal disadvantage based on conviction for a criminal offense. - (4) - (A) If a [regulated seller](/usc/21/802.md?p=46), or a [distributor](/usc/21/802.md?p=11) required to submit reports under [section 830(b)(3) of this title](/usc/21/830.md?p=b-3), violates [paragraph (12)](#a-12) of subsection (a) of this section, or if a [regulated seller](/usc/21/802.md?p=46) violates [paragraph (13)](#a-13) of such subsection, the Attorney General may by order prohibit such seller or [distributor](/usc/21/802.md?p=11) (as the case may be) from selling any [scheduled listed chemical product](/usc/21/802.md?p=45-A). Any sale of such a product in violation of such an order is subject to the same penalties as apply under [paragraph (2)](#c-2). - (B) An order under [subparagraph (A)](#c-4-A) may be imposed only through the same procedures as apply under [section 824(c) of this title](/usc/21/824.md?p=c) for an order to show cause. # §843. Prohibited acts C - (a) **Unlawful acts—** It shall be unlawful for any [person](/usc/21/379j–21.md?p=k-10) knowingly or intentionally— - (1) who is a registrant to [distribute](/usc/21/802.md?p=11) a [controlled substance](/usc/21/802.md?p=6) classified in schedule I or II, in the course of his legitimate business, except pursuant to an order or an order form as required by [section 828 of this title](/usc/21/828.md); - (2) to use in the course of the [manufacture](/usc/21/802.md?p=15), [distribution](/usc/21/360eee.md?p=5), or dispensing of a [controlled substance](/usc/21/802.md?p=6), or to use for the purpose of acquiring or obtaining a [controlled substance](/usc/21/802.md?p=6), a registration number which is fictitious, revoked, suspended, expired, or issued to another [person](/usc/21/379j–21.md?p=k-10); - (3) to acquire or obtain possession of a [controlled substance](/usc/21/802.md?p=6) by misrepresentation, fraud, forgery, deception, or subterfuge; - (4) - (A) to furnish false or fraudulent material information in, or omit any material information from, any application, report, record, or other document required to be made, kept, or filed under this subchapter or subchapter II, or (B) to present false or fraudulent identification where the [person](/usc/21/379j–21.md?p=k-10) is receiving or purchasing a [listed chemical](/usc/21/802.md?p=33) and the [person](/usc/21/379j–21.md?p=k-10) is required to present identification under [section 830(a) of this title](/usc/21/830.md?p=a); - (5) to make, [distribute](/usc/21/802.md?p=11), or possess any punch, die, plate, stone, or other thing designed to print, imprint, or reproduce the trademark, trade name, or other identifying mark, imprint, or [device](/usc/21/355–2.md?p=a-3) of another or any likeness of any of the foregoing upon any [drug](/usc/21/321.md?p=g-1) or container or labeling thereof so as to render such [drug](/usc/21/321.md?p=g-1) a [counterfeit substance](/usc/21/802.md?p=7); - (6) to possess any three-neck round-bottom flask, tableting machine, encapsulating machine, or gelatin capsule, or any equipment, chemical, product, or material which may be used to [manufacture](/usc/21/802.md?p=15) a [controlled substance](/usc/21/802.md?p=6) or [listed chemical](/usc/21/802.md?p=33), knowing, intending, or having reasonable cause to believe, that it will be used to [manufacture](/usc/21/802.md?p=15) a [controlled substance](/usc/21/802.md?p=6) or [listed chemical](/usc/21/802.md?p=33) in violation of this subchapter or subchapter II; - (7) to [manufacture](/usc/21/802.md?p=15), [distribute](/usc/21/802.md?p=11), export, or import any three-neck round-bottom flask, tableting machine, encapsulating machine, or gelatin capsule, or any equipment, chemical, product, or material which may be used to [manufacture](/usc/21/802.md?p=15) a [controlled substance](/usc/21/802.md?p=6) or [listed chemical](/usc/21/802.md?p=33), knowing, intending, or having reasonable cause to believe, that it will be used to [manufacture](/usc/21/802.md?p=15) a [controlled substance](/usc/21/802.md?p=6) or [listed chemical](/usc/21/802.md?p=33) in violation of this subchapter or subchapter II or, in the case of an exportation, in violation of this subchapter or subchapter II or of the laws of the country to which it is exported; - (8) to create a [chemical mixture](/usc/21/802.md?p=40) for the purpose of evading a requirement of [section 830 of this title](/usc/21/830.md) or to receive a [chemical mixture](/usc/21/802.md?p=40) created for that purpose; or - (9) to [distribute](/usc/21/802.md?p=11), import, or export a [list I chemical](/usc/21/802.md?p=34) without the registration required by this subchapter or subchapter II. - (b) **Communication facility—** It shall be unlawful for any [person](/usc/21/379j–21.md?p=k-10) knowingly or intentionally to use any communication facility in committing or in causing or facilitating the commission of any act or acts constituting a [felony](/usc/21/802.md?p=13) under any provision of this subchapter or subchapter II. Each separate use of a communication facility shall be a separate offense under this subsection. For purposes of this subsection, the term “communication facility” means any and all public and private instrumentalities used or useful in the transmission of writing, signs, signals, pictures, or sounds of all kinds and includes mail, telephone, wire, radio, and all other means of communication. - (c) **Advertisement—** - (1) It shall be unlawful for any [person](/usc/21/379j–21.md?p=k-10) to place in any newspaper, magazine, handbill, or other publications, any written advertisement knowing that it has the purpose of seeking or offering illegally to receive, buy, or [distribute](/usc/21/802.md?p=11) a Schedule[^1] I [controlled substance](/usc/21/802.md?p=6). As used in this section the term “advertisement” includes, in addition to its ordinary meaning, such advertisements as those for a catalog of Schedule[^1] I [controlled substances](/usc/21/802.md?p=6) and any similar written advertisement that has the purpose of seeking or offering illegally to receive, buy, or [distribute](/usc/21/802.md?p=11) a Schedule[^1] I [controlled substance](/usc/21/802.md?p=6). The term “advertisement” does not include material which merely advocates the use of a similar material, which advocates a position or practice, and does not attempt to propose or facilitate an actual transaction in a Schedule[^1] I [controlled substance](/usc/21/802.md?p=6). - (2) - (A) It shall be unlawful for any [person](/usc/21/379j–21.md?p=k-10) to knowingly or intentionally use the [Internet](/usc/21/802.md?p=50), or cause the [Internet](/usc/21/802.md?p=50) to be used, to advertise the sale of, or to offer to sell, [distribute](/usc/21/802.md?p=11), or [dispense](/usc/21/802.md?p=10), a [controlled substance](/usc/21/802.md?p=6) where such sale, [distribution](/usc/21/360eee.md?p=5), or dispensing is not [authorized](/usc/21/360eee–1.md?p=a-6) by this subchapter or by the [Controlled Substances](/usc/21/802.md?p=6) Import and Export Act [[21 U.S.C. 951](/usc/21/951.md) et seq.]. - (B) Examples of activities that violate [subparagraph (A)](#c-2-A) include, but are not limited to, knowingly or intentionally causing the placement on the [Internet](/usc/21/802.md?p=50) of an [advertisement](#c-1) that refers to or directs prospective buyers to [Internet](/usc/21/802.md?p=50) sellers of [controlled substances](/usc/21/802.md?p=6) who are not registered with a modification under [section 823(g) of this title](/usc/21/823.md?p=g). - (C) [Subparagraph (A)](#c-2-A) does not apply to material that either— - (i) merely advertises the [distribution](/usc/21/360eee.md?p=5) of [controlled substances](/usc/21/802.md?p=6) by nonpractitioners to the extent [authorized](/usc/21/360eee–1.md?p=a-6) by their registration under this subchapter; or - (ii) merely advocates the use of a [controlled substance](/usc/21/802.md?p=6) or includes pricing information without attempting to facilitate an actual transaction involving a [controlled substance](/usc/21/802.md?p=6). - (d) **Penalties—** - (1) Except as provided in [paragraph (2)](#d-2), any [person](/usc/21/379j–21.md?p=k-10) who violates this section shall be sentenced to a term of imprisonment of not more than 4 years, a fine under [title 18](/usc/18.md), or both; except that if any [person](/usc/21/379j–21.md?p=k-10) commits such a violation after one or more prior convictions of him for violation of this section, or for a [felony](/usc/21/802.md?p=13) under any other provision of this subchapter or subchapter II or other law of the [United States](/usc/21/802.md?p=28) relating to [narcotic drugs](/usc/21/802.md?p=17), [marihuana](/usc/21/802.md?p=16-A), or [depressant or stimulant substances](/usc/21/802.md?p=9), have become final, such [person](/usc/21/379j–21.md?p=k-10) shall be sentenced to a term of imprisonment of not more than 8 years, a fine under [title 18](/usc/18.md), or both. - (2) Any [person](/usc/21/379j–21.md?p=k-10) who, with the intent to [manufacture](/usc/21/802.md?p=15) or to facilitate the [manufacture](/usc/21/802.md?p=15) of methamphetamine, violates paragraph [(6)](#a-6) or [(7)](#a-7) of subsection (a), shall be sentenced to a term of imprisonment of not more than 10 years, a fine under [title 18](/usc/18.md), or both; except that if any [person](/usc/21/379j–21.md?p=k-10) commits such a violation after one or more prior convictions of that [person](/usc/21/379j–21.md?p=k-10)— - (A) for a violation of paragraph [(6)](#a-6) or [(7)](#a-7) of subsection (a); - (B) for a [felony](/usc/21/802.md?p=13) under any other provision of this subchapter or subchapter II of this chapter;[^2] or - (C) under any other law of the [United States](/usc/21/802.md?p=28) or any [State](/usc/21/802.md?p=26) relating to [controlled substances](/usc/21/802.md?p=6) or [listed chemicals](/usc/21/802.md?p=33), has become final, such [person](/usc/21/379j–21.md?p=k-10) shall be sentenced to a term of imprisonment of not more than 20 years, a fine under [title 18](/usc/18.md), or both. - (e) **Additional penalties—** In addition to any other applicable penalty, any [person](/usc/21/379j–21.md?p=k-10) convicted of a [felony](/usc/21/802.md?p=13) violation of this section relating to the receipt, [distribution](/usc/21/360eee.md?p=5), [manufacture](/usc/21/802.md?p=15), exportation, or importation of a [listed chemical](/usc/21/802.md?p=33) may be enjoined from engaging in any transaction involving a [listed chemical](/usc/21/802.md?p=33) for not more than ten years. - (f) **Injunctions—** - (1) In addition to any penalty provided in this section, the Attorney General is [authorized](/usc/21/360eee–1.md?p=a-6) to commence a civil action for appropriate declaratory or injunctive relief relating to violations of this section, [section 842 of this title](/usc/21/842.md), or 856[^3] of this title. - (2) Any action under this subsection may be brought in the district court of the [United States](/usc/21/802.md?p=28) for the district in which the defendant is located or resides or is doing business. - (3) Any order or judgment issued by the court pursuant to this subsection shall be tailored to restrain violations of this section or [section 842 of this title](/usc/21/842.md). - (4) The court shall proceed as soon as practicable to the hearing and determination of such an action. An action under this subsection is governed by the Federal Rules of Civil Procedure except that, if an indictment has been returned against the respondent, discovery is governed by the Federal Rules of Criminal Procedure. # §844. Penalties for simple possession - (a) **Unlawful acts; penalties—** It shall be unlawful for any [person](/usc/21/379j–21.md?p=k-10) knowingly or intentionally to possess a [controlled substance](/usc/21/802.md?p=6) unless such substance was obtained directly, or pursuant to a valid prescription or order, from a [practitioner](/usc/21/802.md?p=21), while acting in the course of his professional practice, or except as otherwise [authorized](/usc/21/360eee–1.md?p=a-6) by this subchapter or subchapter II. It shall be unlawful for any [person](/usc/21/379j–21.md?p=k-10) knowingly or intentionally to possess any [list I chemical](/usc/21/802.md?p=34) obtained pursuant to or under authority of a registration issued to that [person](/usc/21/379j–21.md?p=k-10) under [section 823 of this title](/usc/21/823.md) or [section 958 of this title](/usc/21/958.md) if that registration has been revoked or suspended, if that registration has expired, or if the registrant has ceased to do business in the manner contemplated by his registration. It shall be unlawful for any [person](/usc/21/379j–21.md?p=k-10) to knowingly or intentionally purchase [at retail](/usc/21/802.md?p=48) during a 30 day period more than 9 grams of ephedrine base, pseudoephedrine base, or phenylpropanolamine base in a [scheduled listed chemical product](/usc/21/802.md?p=45-A), except that, of such 9 grams, not more than 7.5 grams may be imported by means of shipping through any private or commercial carrier or the Postal Service. Any [person](/usc/21/379j–21.md?p=k-10) who violates this subsection may be sentenced to a term of imprisonment of not more than 1 year, and shall be fined a minimum of $1,000, or both, except that if he commits such offense after a prior conviction under this subchapter or subchapter II, or a prior conviction for any [drug, narcotic, or chemical offense](#c) chargeable under the law of any [State](/usc/21/802.md?p=26), has become final, he shall be sentenced to a term of imprisonment for not less than 15 days but not more than 2 years, and shall be fined a minimum of $2,500, except, further, that if he commits such offense after two or more prior convictions under this subchapter or subchapter II, or two or more prior convictions for any [drug, narcotic, or chemical offense](#c) chargeable under the law of any [State](/usc/21/802.md?p=26), or a combination of two or more such offenses have become final, he shall be sentenced to a term of imprisonment for not less than 90 days but not more than 3 years, and shall be fined a minimum of $5,000. Notwithstanding any penalty provided in this subsection, any [person](/usc/21/379j–21.md?p=k-10) convicted under this subsection for the possession of flunitrazepam shall be imprisoned for not more than 3 years, shall be fined as otherwise provided in this section, or both. The imposition or execution of a minimum sentence required to be imposed under this subsection shall not be suspended or deferred. Further, upon conviction, a [person](/usc/21/379j–21.md?p=k-10) who violates this subsection shall be fined the reasonable costs of the investigation and prosecution of the offense, including the costs of prosecution of an offense as defined in sections [1918](/usc/28/1918.md) and [1920](/usc/28/1920.md) of title 28, except that this sentence shall not apply and a fine under this section need not be imposed if the court determines under the provision of [title 18](/usc/18.md) that the defendant lacks the ability to pay. - (b) **Repealed. Pub. L. 98–473, title II, § 219(a), Oct. 12, 1984, 98 Stat. 2027—** - (c) **“Drug, narcotic, or chemical offense” defined—** As used in this section, the term “drug, narcotic, or chemical offense” means any offense which proscribes the possession, [distribution](/usc/21/360eee.md?p=5), [manufacture](/usc/21/802.md?p=15), cultivation, sale, transfer, or the attempt or conspiracy to possess, [distribute](/usc/21/802.md?p=11), [manufacture](/usc/21/802.md?p=15), cultivate, sell or transfer any substance the possession of which is prohibited under this subchapter. # §844a. Civil penalty for possession of small amounts of certain controlled substances - (a) **In general—** Any individual who knowingly possesses a [controlled substance](/usc/21/802.md?p=6) that is listed in [section 841(b)(1)(A) of this title](/usc/21/841.md?p=b-1-A) in violation of [section 844 of this title](/usc/21/844.md) in an amount that, as specified by regulation of the Attorney General, is a personal use amount shall be liable to the [United States](/usc/21/802.md?p=28) for a civil penalty in an amount not to exceed $10,000 for each such violation. - (b) **Income and net assets—** The income and net assets of an individual shall not be relevant to the determination whether to assess a civil penalty under this section or to prosecute the individual criminally. However, in determining the amount of a penalty under this section, the income and net assets of an individual shall be considered. - (c) **Prior conviction—** A civil penalty may not be assessed under this section if the individual previously was convicted of a Federal or [State](/usc/21/802.md?p=26) offense relating to a [controlled substance](/usc/21/802.md?p=6). - (d) **Limitation on number of assessments—** A civil penalty may not be assessed on an individual under this section on more than two separate occasions. - (e) **Assessment—** A civil penalty under this section may be assessed by the Attorney General only by an order made on the record after opportunity for a hearing in accordance with [section 554 of title 5](/usc/5/554.md). The Attorney General shall provide written notice to the individual who is the subject of the proposed order informing the individual of the opportunity to receive such a hearing with respect to the proposed order. The hearing may be held only if the individual makes a request for the hearing before the expiration of the 30-day period beginning on the date such notice is issued. - (f) **Compromise—** The Attorney General may compromise, modify, or remit, with or without conditions, any civil penalty imposed under this section. - (g) **Judicial review—** If the Attorney General issues an order pursuant to [subsection (e)](#e) after a hearing described in such subsection, the individual who is the subject of the order may, before the expiration of the 30-day period beginning on the date the order is issued, bring a civil action in the appropriate district court of the [United States](/usc/21/802.md?p=28). In such action, the law and the facts of the violation and the assessment of the civil penalty shall be determined de novo, and shall include the right of a trial by jury, the right to counsel, and the right to confront witnesses. The facts of the violation shall be proved beyond a reasonable doubt. - (h) **Civil action—** If an individual does not request a hearing pursuant to [subsection (e)](#e) and the Attorney General issues an order pursuant to such subsection, or if an individual does not under [subsection (g)](#g) seek judicial review of such an order, the Attorney General may commence a civil action in any appropriate district court of the [United States](/usc/21/802.md?p=28) for the purpose of recovering the amount assessed and an amount representing interest at a rate computed in accordance with [section 1961 of title 28](/usc/28/1961.md). Such interest shall accrue from the expiration of the 30-day period described in [subsection (g)](#g). In such an action, the decision of the Attorney General to issue the order, and the amount of the penalty assessed by the Attorney General, shall not be subject to review. - (i) **Limitation—** The Attorney General may not under this subsection[^1] commence proceeding against an individual after the expiration of the 5-year period beginning on the date on which the individual allegedly violated [subsection (a)](#a). - (j) **Expungement procedures—** The Attorney General shall dismiss the proceedings under this section against an individual upon application of such individual at any time after the expiration of 3 years if— - (1) the individual has not previously been assessed a civil penalty under this section; - (2) the individual has paid the assessment; - (3) the individual has complied with any conditions imposed by the Attorney General; - (4) the individual has not been convicted of a Federal or [State](/usc/21/802.md?p=26) offense relating to a [controlled substance](/usc/21/802.md?p=6); and - (5) the individual agrees to submit to a [drug](/usc/21/321.md?p=g-1) test, and such test shows the individual to be [drug](/usc/21/321.md?p=g-1) free. A nonpublic record of a disposition under this subsection shall be retained by the Department of Justice solely for the purpose of determining in any subsequent proceeding whether the [person](/usc/21/379j–21.md?p=k-10) qualified for a civil penalty or expungement under this section. If a record is expunged under this subsection, an individual concerning whom such an expungement has been made shall not be held thereafter under any provision of law to be guilty of perjury, false swearing, or making a false statement by reason of his failure to recite or acknowledge a proceeding under this section or the results thereof in response to an inquiry made of him for any purpose. # [§§845 to 845b. Transferred — transferred] # §846. Attempt and conspiracy Any [person](/usc/21/379j–21.md?p=k-10) who attempts or conspires to commit any offense defined in this subchapter shall be subject to the same penalties as those prescribed for the offense, the commission of which was the object of the attempt or conspiracy. # §847. Additional penalties Any penalty imposed for violation of this subchapter shall be in addition to, and not in lieu of, any civil or administrative penalty or sanction [authorized](/usc/21/360eee–1.md?p=a-6) by law. # §848. Continuing criminal enterprise - (a) **Penalties; forfeitures—** Any [person](/usc/21/379j–21.md?p=k-10) who engages in a continuing criminal enterprise shall be sentenced to a term of imprisonment which may not be less than 20 years and which may be up to life imprisonment, to a fine not to exceed the greater of that [authorized](/usc/21/360eee–1.md?p=a-6) in accordance with the provisions of [title 18](/usc/18.md) or $2,000,000 if the defendant is an individual or $5,000,000 if the defendant is other than an individual, and to the forfeiture prescribed in [section 853 of this title](/usc/21/853.md); except that if any [person](/usc/21/379j–21.md?p=k-10) engages in such activity after one or more prior convictions of him under this section have become final, he shall be sentenced to a term of imprisonment which may not be less than 30 years and which may be up to life imprisonment, to a fine not to exceed the greater of twice the amount [authorized](/usc/21/360eee–1.md?p=a-6) in accordance with the provisions of [title 18](/usc/18.md) or $4,000,000 if the defendant is an individual or $10,000,000 if the defendant is other than an individual, and to the forfeiture prescribed in [section 853 of this title](/usc/21/853.md). - (b) **Life imprisonment for engaging in continuing criminal enterprise—** Any [person](/usc/21/379j–21.md?p=k-10) who engages in a continuing criminal enterprise shall be imprisoned for life and fined in accordance with [subsection (a)](#a), if— - (1) such [person](/usc/21/379j–21.md?p=k-10) is the principal [administrator](/usc/21/1523.md?p=1), organizer, or leader of the enterprise or is one of several such principal [administrators](/usc/21/1523.md?p=1), organizers, or leaders; and - (2) - (A) the violation referred to in [subsection (c)(1)](#c-1) involved at least 300 times the quantity of a substance described in sub[section 841(b)(1)(B) of this title](/usc/21/841.md?p=b-1-B), or - (B) the enterprise, or any other enterprise in which the defendant was the principal or one of several principal [administrators](/usc/21/1523.md?p=1), organizers, or leaders, received $10 million dollars in gross receipts during any twelve-month period of its existence for the [manufacture](/usc/21/802.md?p=15), importation, or [distribution](/usc/21/360eee.md?p=5) of a substance described in [section 841(b)(1)(B) of this title](/usc/21/841.md?p=b-1-B). - (c) **“Continuing criminal enterprise” defined—** For purposes of [subsection (a)](#a), a [person](/usc/21/379j–21.md?p=k-10) is engaged in a continuing criminal enterprise if— - (1) he violates any provision of this subchapter or subchapter II the punishment for which is a [felony](/usc/21/802.md?p=13), and - (2) such violation is a part of a continuing series of violations of this subchapter or subchapter II— - (A) which are undertaken by such [person](/usc/21/379j–21.md?p=k-10) in concert with five or more other [persons](/usc/21/379j–21.md?p=k-10) with respect to whom such [person](/usc/21/379j–21.md?p=k-10) occupies a position of organizer, a supervisory position, or any other position of management, and - (B) from which such [person](/usc/21/379j–21.md?p=k-10) obtains substantial income or resources. - (d) **Suspension of sentence and probation prohibited—** In the case of any sentence imposed under this section, imposition or execution of such sentence shall not be suspended, probation shall not be granted, and the Act of July 15, 1932 (D.C. Code, [secs. 24–203—24–207](/usc/21/24–203..24–207.md)), shall not apply. - (e) **Death penalty—** - (1) In addition to the other penalties set forth in this section— - (A) any [person](/usc/21/379j–21.md?p=k-10) engaging in or working in furtherance of a continuing criminal enterprise, or any [person](/usc/21/379j–21.md?p=k-10) engaging in an offense punishable under [section 841(b)(1)(A)](/usc/21/841.md?p=b-1-A)[^1] of this title or [section 960(b)(1)](/usc/21/960.md?p=b-1)[^1] of this title who intentionally kills or counsels, commands, induces, procures, or causes the intentional killing of an individual and such killing results, shall be sentenced to any term of imprisonment, which shall not be less than 20 years, and which may be up to life imprisonment, or may be sentenced to death; and - (B) any [person](/usc/21/379j–21.md?p=k-10), during the commission of, in furtherance of, or while attempting to avoid apprehension, prosecution or service of a prison sentence for, a [felony](/usc/21/802.md?p=13) violation of this subchapter or subchapter II who intentionally kills or counsels, commands, induces, procures, or causes the intentional killing of any Federal, [State](/usc/21/802.md?p=26), or local [law enforcement officer](#e-2) engaged in, or on account of, the performance of such officer’s official duties and such killing results, shall be sentenced to any term of imprisonment, which shall not be less than 20 years, and which may be up to life imprisonment, or may be sentenced to death. - (2) As used in [paragraph (1)(B)](#e-1-B), the term “law enforcement officer” means a public servant [authorized](/usc/21/360eee–1.md?p=a-6) by law or by a Government agency or Congress to conduct or engage in the prevention, investigation, prosecution or adjudication of an offense, and includes those engaged in corrections, probation, or parole functions. - (g) **[^2] to (p) Repealed. Pub. L. 109–177, title II, § 221(2), Mar. 9, 2006, 120 Stat. 231—** - (q) **Repealed. Pub. L. 109–177, title II, §§ 221(4), 222(c), Mar. 9, 2006, 120 Stat. 231, 232—** - (r) **Repealed. Pub. L. 109–177, title II, § 221(3), Mar. 9, 2006, 120 Stat. 231—** - (s) **Special provision for methamphetamine—** For the purposes of [subsection (b)](#b), in the case of continuing criminal enterprise involving methamphetamine or its salts, [isomers](/usc/21/802.md?p=14), or salts of [isomers](/usc/21/802.md?p=14), [paragraph (2)(A)](#b-2-A) shall be applied by substituting “200” for “300”, and [paragraph (2)(B)](#b-2-B) shall be applied by substituting “$5,000,000” for “$10 million dollars”. # §849. Transportation safety offenses (a) Definitions In this section— “safety rest area” means a roadside [facility](/usc/21/350g.md?p=o-2) with parking [facilities](/usc/21/350g.md?p=o-2) for the rest or other needs of motorists. “truck stop” means a [facility](/usc/21/350g.md?p=o-2) (including any parking lot appurtenant thereto) that— (A) has the capacity to provide fuel or service, or both, to any commercial motor vehicle (as defined in [section 31301 of title 49](/usc/49/31301.md)), operating in commerce (as defined in that section); and (B) is located within 2,500 feet of the National System of Interstate and Defense Highways or the Federal-Aid Primary System. (b) First offense A [person](/usc/21/379j–21.md?p=k-10) who violates [section 841(a)(1) of this title](/usc/21/841.md?p=a-1) or [section 856 of this title](/usc/21/856.md) by distributing or possessing with intent to [distribute](/usc/21/802.md?p=11) a [controlled substance](/usc/21/802.md?p=6) in or on, or within 1,000 feet of, a truck stop or safety rest area is (except as provided in subsection (b))[^1] subject to— (1) twice the maximum punishment [authorized](/usc/21/360eee–1.md?p=a-6) by [section 841(b) of this title](/usc/21/841.md?p=b); and (2) twice any term of supervised release [authorized](/usc/21/360eee–1.md?p=a-6) by [section 841(b) of this title](/usc/21/841.md?p=b) for a first offense. (c) Subsequent offense A [person](/usc/21/379j–21.md?p=k-10) who violates [section 841(a)(1) of this title](/usc/21/841.md?p=a-1) or [section 856 of this title](/usc/21/856.md) by distributing or possessing with intent to [distribute](/usc/21/802.md?p=11) a [controlled substance](/usc/21/802.md?p=6) in or on, or within 1,000 feet of, a truck stop or a safety rest area after a prior conviction or convictions under subsection (a)[^2] have become final is subject to— (1) 3 times the maximum punishment [authorized](/usc/21/360eee–1.md?p=a-6) by [section 841(b) of this title](/usc/21/841.md?p=b); and (2) 3 times any term of supervised release [authorized](/usc/21/360eee–1.md?p=a-6) by [section 841(b) of this title](/usc/21/841.md?p=b) for a first offense. # §850. Information for sentencing Except as otherwise provided in this subchapter or section 242a(a)[^1] of [title 42](/usc/42.md), no limitation shall be placed on the information concerning the background, character, and conduct of a [person](/usc/21/379j–21.md?p=k-10) convicted of an offense which a court of the [United States](/usc/21/802.md?p=28) may receive and consider for the purpose of imposing an appropriate sentence under this subchapter or subchapter II. # §851. Proceedings to establish prior convictions - (a) **Information filed by United States Attorney—** - (1) No [person](/usc/21/379j–21.md?p=k-10) who stands convicted of an offense under this part shall be sentenced to increased punishment by reason of one or more prior convictions, unless before trial, or before entry of a plea of guilty, the [United States](/usc/21/802.md?p=28) attorney files an information with the court (and serves a copy of such information on the [person](/usc/21/379j–21.md?p=k-10) or counsel for the [person](/usc/21/379j–21.md?p=k-10)) stating in writing the previous convictions to be relied upon. Upon a showing by the [United States](/usc/21/802.md?p=28) attorney that facts regarding prior convictions could not with due diligence be obtained prior to trial or before entry of a plea of guilty, the court may postpone the trial or the taking of the plea of guilty for a reasonable period for the purpose of obtaining such facts. Clerical mistakes in the information may be amended at any time prior to the pronouncement of sentence. - (2) An information may not be filed under this section if the increased punishment which may be imposed is imprisonment for a term in excess of three years unless the [person](/usc/21/379j–21.md?p=k-10) either waived or was afforded prosecution by indictment for the offense for which such increased punishment may be imposed. - (b) **Affirmation or denial of previous conviction—** If the [United States](/usc/21/802.md?p=28) attorney files an information under this section, the court shall after conviction but before pronouncement of sentence inquire of the [person](/usc/21/379j–21.md?p=k-10) with respect to whom the information was filed whether he affirms or denies that he has been previously convicted as alleged in the information, and shall inform him that any challenge to a prior conviction which is not made before sentence is imposed may not thereafter be raised to attack the sentence. - (c) **Denial; written response; hearing—** - (1) If the [person](/usc/21/379j–21.md?p=k-10) denies any allegation of the information of prior conviction, or claims that any conviction alleged is invalid, he shall file a written response to the information. A copy of the response shall be served upon the [United States](/usc/21/802.md?p=28) attorney. The court shall hold a hearing to determine any issues raised by the response which would except the [person](/usc/21/379j–21.md?p=k-10) from increased punishment. The failure of the [United States](/usc/21/802.md?p=28) attorney to include in the information the complete criminal record of the [person](/usc/21/379j–21.md?p=k-10) or any facts in addition to the convictions to be relied upon shall not constitute grounds for invalidating the notice given in the information required by [subsection (a)(1)](#a-1). The hearing shall be before the court without a jury and either party may introduce evidence. Except as otherwise provided in paragraph (2) of this subsection, the [United States](/usc/21/802.md?p=28) attorney shall have the burden of proof beyond a reasonable doubt on any issue of fact. At the request of either party, the court shall enter findings of fact and conclusions of law. - (2) A [person](/usc/21/379j–21.md?p=k-10) claiming that a conviction alleged in the information was obtained in violation of the Constitution of the [United States](/usc/21/802.md?p=28) shall set forth his claim, and the factual basis therefor, with particularity in his response to the information. The [person](/usc/21/379j–21.md?p=k-10) shall have the burden of proof by a preponderance of the evidence on any issue of fact raised by the response. Any challenge to a prior conviction, not raised by response to the information before an increased sentence is imposed in reliance thereon, shall be waived unless good cause be shown for failure to make a timely challenge. - (d) **Imposition of sentence—** - (1) If the [person](/usc/21/379j–21.md?p=k-10) files no response to the information, or if the court determines, after hearing, that the [person](/usc/21/379j–21.md?p=k-10) is subject to increased punishment by reason of prior convictions, the court shall proceed to impose sentence upon him as provided by this part. - (2) If the court determines that the [person](/usc/21/379j–21.md?p=k-10) has not been convicted as alleged in the information, that a conviction alleged in the information is invalid, or that the [person](/usc/21/379j–21.md?p=k-10) is otherwise not subject to an increased sentence as a matter of law, the court shall, at the request of the [United States](/usc/21/802.md?p=28) attorney, postpone sentence to allow an appeal from that determination. If no such request is made, the court shall impose sentence as provided by this part. The [person](/usc/21/379j–21.md?p=k-10) may appeal from an order postponing sentence as if sentence had been pronounced and a final judgment of conviction entered. - (e) **Statute of limitations—** No [person](/usc/21/379j–21.md?p=k-10) who stands convicted of an offense under this part may challenge the validity of any prior conviction alleged under this section which occurred more than five years before the date of the information alleging such prior conviction. # §852. Application of treaties and other international agreements Nothing in the [Single Convention on Narcotic Drugs](/usc/21/802.md?p=31), the [Convention on Psychotropic Substances](/usc/21/802.md?p=31), or other treaties or international agreements shall be construed to limit the provision of treatment, education, or rehabilitation as alternatives to conviction or criminal penalty for offenses involving any [drug](/usc/21/321.md?p=g-1) or other substance subject to [control](/usc/21/802.md?p=5) under any such treaty or agreement. # §853. Criminal forfeitures - (a) **Property subject to criminal forfeiture—** Any [person](/usc/21/379j–21.md?p=k-10) convicted of a violation of this subchapter or subchapter II punishable by imprisonment for more than one year shall forfeit to the [United States](/usc/21/802.md?p=28), irrespective of any provision of [State](/usc/21/802.md?p=26) law— - (1) any property constituting, or derived from, any proceeds the [person](/usc/21/379j–21.md?p=k-10) obtained, directly or indirectly, as the result of such violation; - (2) any of the [person](/usc/21/379j–21.md?p=k-10)’s property used, or intended to be used, in any manner or part, to commit, or to facilitate the commission of, such violation; and - (3) in the case of a [person](/usc/21/379j–21.md?p=k-10) convicted of engaging in a continuing criminal enterprise in violation of [section 848 of this title](/usc/21/848.md), the [person](/usc/21/379j–21.md?p=k-10) shall forfeit, in addition to any property described in paragraph [(1)](#a-1) or [(2)](#a-2), any of his interest in, claims against, and property or contractual rights affording a source of [control](/usc/21/802.md?p=5) over, the continuing criminal enterprise. The court, in imposing sentence on such [person](/usc/21/379j–21.md?p=k-10), shall order, in addition to any other sentence imposed pursuant to this subchapter or subchapter II, that the [person](/usc/21/379j–21.md?p=k-10) forfeit to the [United States](/usc/21/802.md?p=28) all property described in this subsection. In lieu of a fine otherwise [authorized](/usc/21/360eee–1.md?p=a-6) by this part, a defendant who derives profits or other proceeds from an offense may be fined not more than twice the gross profits or other proceeds. - (b) **Meaning of term “property”—** Property subject to criminal forfeiture under this section includes— - (1) real property, including things growing on, affixed to, and found in land; and - (2) tangible and intangible personal property, including rights, privileges, interests, claims, and securities. - (c) **Third party transfers—** All right, title, and interest in property described in [subsection (a)](#a) vests in the [United States](/usc/21/802.md?p=28) upon the commission of the act giving rise to forfeiture under this section. Any such property that is subsequently transferred to a [person](/usc/21/379j–21.md?p=k-10) other than the defendant may be the subject of a special verdict of forfeiture and thereafter shall be ordered forfeited to the [United States](/usc/21/802.md?p=28), unless the transferee establishes in a hearing pursuant to [subsection (n)](#n) that he is a bona fide purchaser for value of such property who at the time of purchase was reasonably without cause to believe that the property was subject to forfeiture under this section. - (d) **Rebuttable presumption—** There is a rebuttable presumption at trial that any property of a [person](/usc/21/379j–21.md?p=k-10) convicted of a [felony](/usc/21/802.md?p=13) under this subchapter or subchapter II is subject to forfeiture under this section if the [United States](/usc/21/802.md?p=28) establishes by a preponderance of the evidence that— - (1) such property was acquired by such [person](/usc/21/379j–21.md?p=k-10) during the period of the violation of this subchapter or subchapter II or within a reasonable time after such period; and - (2) there was no likely source for such property other than the violation of this subchapter or subchapter II. - (e) **Protective orders—** - (1) Upon application of the [United States](/usc/21/802.md?p=28), the court may enter a restraining order or injunction, require the execution of a satisfactory performance bond, or take any other action to preserve the availability of property described in [subsection (a)](#a) for forfeiture under this section— - (A) upon the filing of an indictment or information charging a violation of this subchapter or subchapter II for which criminal forfeiture may be ordered under this section and alleging that the property with respect to which the order is sought would, in the event of conviction, be subject to forfeiture under this section; or - (B) prior to the filing of such an indictment or information, if, after notice to [persons](/usc/21/379j–21.md?p=k-10) appearing to have an interest in the property and opportunity for a hearing, the court determines that— - (i) there is a substantial probability that the [United States](/usc/21/802.md?p=28) will prevail on the issue of forfeiture and that failure to enter the order will result in the property being destroyed, removed from the jurisdiction of the court, or otherwise made unavailable for forfeiture; and - (ii) the need to preserve the availability of the property through the entry of the requested order outweighs the hardship on any party against whom the order is to be entered: - (2) A temporary restraining order under this subsection may be entered upon application of the [United States](/usc/21/802.md?p=28) without notice or opportunity for a hearing when an information or indictment has not yet been filed with respect to the property, if the [United States](/usc/21/802.md?p=28) demonstrates that there is probable cause to believe that the property with respect to which the order is sought would, in the event of conviction, be subject to forfeiture under this section and that provision of notice will jeopardize the availability of the property for forfeiture. Such a temporary order shall expire not more than fourteen days after the date on which it is entered, unless extended for good cause shown or unless the party against whom it is entered consents to an extension for a longer period. A hearing requested concerning an order entered under this paragraph shall be held at the earliest possible time and prior to the expiration of the temporary order. - (3) The court may receive and consider, at a hearing held pursuant to this subsection, evidence and information that would be inadmissible under the Federal Rules of Evidence. - (4) **Order to repatriate and deposit.—** - (A) **In general.—** Pursuant to its authority to enter a pretrial restraining order under this section, the court may order a defendant to repatriate any property that may be seized and forfeited, and to deposit that property pending trial in the registry of the court, or with the [United States](/usc/21/802.md?p=28) Marshals Service or the [Secretary](/usc/21/802.md?p=24) of the Treasury, in an interest-bearing account, if appropriate. - (B) **Failure to comply.—** Failure to comply with an order under this subsection, or an order to repatriate property under [subsection (p)](#p), shall be punishable as a civil or criminal contempt of court, and may also result in an enhancement of the sentence of the defendant under the obstruction of justice provision of the Federal Sentencing Guidelines. - (f) **Warrant of seizure—** The Government may request the issuance of a warrant authorizing the seizure of property subject to forfeiture under this section in the same manner as provided for a search warrant. If the court determines that there is probable cause to believe that the property to be seized would, in the event of conviction, be subject to forfeiture and that an order under [subsection (e)](#e) may not be sufficient to assure the availability of the property for forfeiture, the court shall issue a warrant authorizing the seizure of such property. - (g) **Execution—** Upon entry of an order of forfeiture under this section, the court shall authorize the Attorney General to seize all property ordered forfeited upon such terms and conditions as the court shall deem proper. Following entry of an order declaring the property forfeited, the court may, upon application of the [United States](/usc/21/802.md?p=28), enter such appropriate restraining orders or injunctions, require the execution of satisfactory performance bonds, appoint receivers, conservators, appraisers, accountants, or trustees, or take any other action to protect the interest of the [United States](/usc/21/802.md?p=28) in the property ordered forfeited. Any income accruing to or derived from property ordered forfeited under this section may be used to offset ordinary and necessary expenses to the property which are required by law, or which are necessary to protect the interests of the [United States](/usc/21/802.md?p=28) or third parties. - (h) **Disposition of property—** Following the seizure of property ordered forfeited under this section, the Attorney General shall direct the disposition of the property by sale or any other commercially feasible means, making due provision for the rights of any innocent [persons](/usc/21/379j–21.md?p=k-10). Any property right or interest not exercisable by, or transferable for value to, the [United States](/usc/21/802.md?p=28) shall expire and shall not revert to the defendant, nor shall the defendant or any [person](/usc/21/379j–21.md?p=k-10) acting in concert with him or on his behalf be eligible to purchase forfeited property at any sale held by the [United States](/usc/21/802.md?p=28). Upon application of a [person](/usc/21/379j–21.md?p=k-10), other than the defendant or a [person](/usc/21/379j–21.md?p=k-10) acting in concert with him or on his behalf, the court may restrain or stay the sale or disposition of the property pending the conclusion of any appeal of the criminal case giving rise to the forfeiture, if the applicant demonstrates that proceeding with the sale or disposition of the property will result in irreparable injury, harm, or loss to him. - (i) **Authority of the Attorney General—** With respect to property ordered forfeited under this section, the Attorney General is [authorized](/usc/21/360eee–1.md?p=a-6) to— - (1) grant petitions for mitigation or remission of forfeiture, restore forfeited property to victims of a violation of this subchapter, or take any other action to protect the rights of innocent [persons](/usc/21/379j–21.md?p=k-10) which is in the interest of justice and which is not inconsistent with the provisions of this section; - (2) compromise claims arising under this section; - (3) award compensation to [persons](/usc/21/379j–21.md?p=k-10) providing information resulting in a forfeiture under this section; - (4) direct the disposition by the [United States](/usc/21/802.md?p=28), in accordance with the provisions of [section 881(e) of this title](/usc/21/881.md?p=e), of all property ordered forfeited under this section by public sale or any other commercially feasible means, making due provision for the rights of innocent [persons](/usc/21/379j–21.md?p=k-10); and - (5) take appropriate measures necessary to safeguard and maintain property ordered forfeited under this section pending its disposition. - (j) **Applicability of civil forfeiture provisions—** Except to the extent that they are inconsistent with the provisions of this section, the provisions of [section 881(d) of this title](/usc/21/881.md?p=d) shall apply to a criminal forfeiture under this section. - (k) **Bar on intervention—** Except as provided in [subsection (n)](#n), no party claiming an interest in property subject to forfeiture under this section may— - (1) intervene in a trial or appeal of a criminal case involving the forfeiture of such property under this section; or - (2) commence an action at law or equity against the [United States](/usc/21/802.md?p=28) concerning the validity of his alleged interest in the property subsequent to the filing of an indictment or information alleging that the property is subject to forfeiture under this section. - (l) **Jurisdiction to enter orders—** The district courts of the [United States](/usc/21/802.md?p=28) shall have jurisdiction to enter orders as provided in this section without regard to the location of any property which may be subject to forfeiture under this section or which has been ordered forfeited under this section. - (m) **Depositions—** In order to facilitate the identification and location of property declared forfeited and to facilitate the disposition of petitions for remission or mitigation of forfeiture, after the entry of an order declaring property forfeited to the [United States](/usc/21/802.md?p=28), the court may, upon application of the [United States](/usc/21/802.md?p=28), order that the testimony of any witness relating to the property forfeited be taken by deposition and that any designated book, paper, document, record, recording, or other material not privileged be produced at the same time and place, in the same manner as provided for the taking of depositions under [Rule 15](/usc/18a/crim-15.md) of the Federal Rules of Criminal Procedure. - (n) **Third party interests—** - (1) Following the entry of an order of forfeiture under this section, the [United States](/usc/21/802.md?p=28) shall publish notice of the order and of its intent to dispose of the property in such manner as the Attorney General may direct. The Government may also, to the extent practicable, provide direct written notice to any [person](/usc/21/379j–21.md?p=k-10) known to have alleged an interest in the property that is the subject of the order of forfeiture as a substitute for published notice as to those [persons](/usc/21/379j–21.md?p=k-10) so notified. - (2) Any [person](/usc/21/379j–21.md?p=k-10), other than the defendant, asserting a legal interest in property which has been ordered forfeited to the [United States](/usc/21/802.md?p=28) pursuant to this section may, within thirty days of the final publication of notice or his receipt of notice under [paragraph (1)](#n-1), whichever is earlier, petition the court for a hearing to adjudicate the validity of his alleged interest in the property. The hearing shall be held before the court alone, without a jury. - (3) The petition shall be signed by the petitioner under penalty of perjury and shall set forth the nature and extent of the petitioner’s right, title, or interest in the property, the time and circumstances of the petitioner’s acquisition of the right, title, or interest in the property, any additional facts supporting the petitioner’s claim, and the relief sought. - (4) The hearing on the petition shall, to the extent practicable and consistent with the interests of justice, be held within thirty days of the filing of the petition. The court may consolidate the hearing on the petition with a hearing on any other petition filed by a [person](/usc/21/379j–21.md?p=k-10) other than the defendant under this subsection. - (5) At the hearing, the petitioner may testify and present evidence and witnesses on his own behalf, and cross-examine witnesses who appear at the hearing. The [United States](/usc/21/802.md?p=28) may present evidence and witnesses in rebuttal and in defense of its claim to the property and cross-examine witnesses who appear at the hearing. In addition to testimony and evidence presented at the hearing, the court shall consider the relevant portions of the record of the criminal case which resulted in the order of forfeiture. - (6) If, after the hearing, the court determines that the petitioner has established by a preponderance of the evidence that— - (A) the petitioner has a legal right, title, or interest in the property, and such right, title, or interest renders the order of forfeiture invalid in whole or in part because the right, title, or interest was vested in the petitioner rather than the defendant or was superior to any right, title, or interest of the defendant at the time of the commission of the acts which gave rise to the forfeiture of the property under this section; or - (B) the petitioner is a bona fide purchaser for value of the right, title, or interest in the property and was at the time of purchase reasonably without cause to believe that the property was subject to forfeiture under this section; the court shall amend the order of forfeiture in accordance with its determination. - (7) Following the court’s disposition of all petitions filed under this subsection, or if no such petitions are filed following the expiration of the period provided in [paragraph (2)](#n-2) for the filing of such petitions, the [United States](/usc/21/802.md?p=28) shall have clear title to property that is the subject of the order of forfeiture and may warrant good title to any subsequent purchaser or transferee. - (o) **Construction—** The provisions of this section shall be liberally construed to effectuate its remedial purposes. - (p) **Forfeiture of substitute property—** - (1) **In general—** Paragraph (2) of this subsection shall apply, if any property described in [subsection (a)](#a), as a result of any act or omission of the defendant— - (A) cannot be located upon the exercise of due diligence; - (B) has been transferred or sold to, or deposited with, a third party; - (C) has been placed beyond the jurisdiction of the court; - (D) has been substantially diminished in value; or - (E) has been commingled with other property which cannot be divided without difficulty. - (2) **Substitute property—** In any case described in any of [subparagraphs (A) through (E)](#p-1-A..p-1-E) of paragraph (1), the court shall order the forfeiture of any other property of the defendant, up to the value of any property described in [subparagraphs (A) through (E)](#p-1-A..p-1-E) of paragraph (1), as applicable. - (3) **Return of property to jurisdiction—** In the case of property described in [paragraph (1)(C)](#p-1-C), the court may, in addition to any other action [authorized](/usc/21/360eee–1.md?p=a-6) by this subsection, order the defendant to return the property to the jurisdiction of the court so that the property may be seized and forfeited. - (q) **Restitution for cleanup of clandestine laboratory sites—** The court, when sentencing a defendant convicted of an offense under this subchapter or subchapter II involving the [manufacture](/usc/21/802.md?p=15), the possession, or the possession with intent to [distribute](/usc/21/802.md?p=11), of amphetamine or methamphetamine, shall— - (1) order restitution as provided in sections [3612](/usc/18/3612.md) and [3664](/usc/18/3664.md) of title 18; - (2) order the defendant to reimburse the [United States](/usc/21/802.md?p=28), the [State](/usc/21/802.md?p=26) or local government concerned, or both the [United States](/usc/21/802.md?p=28) and the [State](/usc/21/802.md?p=26) or local government concerned for the costs incurred by the [United States](/usc/21/802.md?p=28) or the [State](/usc/21/802.md?p=26) or local government concerned, as the case may be, for the cleanup associated with the [manufacture](/usc/21/802.md?p=15) of amphetamine or methamphetamine by the defendant, or on premises or in property that the defendant owns, resides, or does business in; and - (3) order restitution to any [person](/usc/21/379j–21.md?p=k-10) injured as a result of the offense as provided in [section 3663A of title 18](/usc/18/3663A.md). # [§853a. Transferred — transferred] # §854. Investment of illicit drug profits - (a) **Prohibition—** It shall be unlawful for any [person](/usc/21/379j–21.md?p=k-10) who has received any income derived, directly or indirectly, from a violation of this subchapter or subchapter II punishable by imprisonment for more than one year in which such [person](/usc/21/379j–21.md?p=k-10) has participated as a principal within the meaning of [section 2 of title 18](/usc/18/2.md), to use or invest, directly or indirectly, any part of such income, or the proceeds of such income, in acquisition of any interest in, or the establishment or operation of, any [enterprise](#c) which is engaged in, or the activities of which affect interstate or foreign commerce. A purchase of securities on the open market for purposes of investment, and without the intention of controlling or participating in the [control](/usc/21/802.md?p=5) of the issuer, or of assisting another to do so, shall not be unlawful under this section if the securities of the issuer held by the purchaser, the members of his immediate family, and his or their accomplices in any violation of this subchapter or subchapter II after such purchase do not amount in the aggregate to 1 per centum of the outstanding securities of any one class, and do not confer, either in law or in fact, the power to elect one or more directors of the issuer. - (b) **Penalty—** Whoever violates this section shall be fined not more than $50,000 or imprisoned not more than ten years, or both. - (c) **“Enterprise” defined—** As used in this section, the term “enterprise” includes any individual, partnership, corporation, association, or other legal entity, and any union or group of individuals associated in fact although not a legal entity. - (d) **Construction—** The provisions of this section shall be liberally construed to effectuate its remedial purposes. # §855. Alternative fine In lieu of a fine otherwise [authorized](/usc/21/360eee–1.md?p=a-6) by this part, a defendant who derives profits or other proceeds from an offense may be fined not more than twice the gross profits or other proceeds. # §856. Maintaining drug-involved premises - (a) **Unlawful acts—** Except as [authorized](/usc/21/360eee–1.md?p=a-6) by this subchapter, it shall be unlawful to— - (1) knowingly open, lease, rent, use, or maintain any place, whether permanently or temporarily, for the purpose of manufacturing, distributing, or using any [controlled substance](/usc/21/802.md?p=6); - (2) manage or [control](/usc/21/802.md?p=5) any place, whether permanently or temporarily, either as an owner, lessee, [agent](/usc/21/802.md?p=3), employee, occupant, or mortgagee, and knowingly and intentionally rent, lease, profit from, or make available for use, with or without compensation, the place for the purpose of unlawfully manufacturing, storing, distributing, or using a [controlled substance](/usc/21/802.md?p=6). - (b) **Criminal penalties—** Any [person](/usc/21/379j–21.md?p=k-10) who violates [subsection (a)](#a) of this section shall be sentenced to a term of imprisonment of not more than 20 years or a fine of not more than $500,000, or both, or a fine of $2,000,000 for a [person](/usc/21/379j–21.md?p=k-10) other than an individual. - (c) **Violation as offense against property—** A violation of [subsection (a)](#a) shall be considered an offense against property for purposes of [section 3663A(c)(1)(A)(ii) of title 18](/usc/18/3663A.md?p=c-1-A-ii). - (d) **Civil penalties—** - (1) Any [person](/usc/21/379j–21.md?p=k-10) who violates [subsection (a)](#a) shall be subject to a civil penalty of not more than the greater of— - (A) $250,000; or - (B) 2 times the gross receipts, either known or estimated, that were derived from each violation that is attributable to the [person](/usc/21/379j–21.md?p=k-10). - (2) If a civil penalty is calculated under [paragraph (1)(B)](#d-1-B), and there is more than 1 defendant, the court may apportion the penalty between multiple violators, but each violator shall be jointly and severally liable for the civil penalty under this subsection. - (e) **Declaratory and injunctive remedies—** Any [person](/usc/21/379j–21.md?p=k-10) who violates [subsection (a)](#a) shall be subject to declaratory and injunctive remedies as set forth in [section 843(f) of this title](/usc/21/843.md?p=f). # [§857. Repealed. Pub. L. 101–647, title XXIV, § 2401(d), Nov. 29, 1990, 104 Stat. 4859 — repealed] # §858. Endangering human life while illegally manufacturing controlled substance Whoever, while manufacturing a [controlled substance](/usc/21/802.md?p=6) in violation of this subchapter, or attempting to do so, or transporting or causing to be transported materials, including chemicals, to do so, creates a substantial risk of harm to human life shall be fined in accordance with [title 18](/usc/18.md) or imprisoned not more than 10 years, or both. # §859. Distribution to persons under age twenty-one - (a) **First offense—** Except as provided in [section 860 of this title](/usc/21/860.md), any [person](/usc/21/379j–21.md?p=k-10) at least eighteen years of age who violates [section 841(a)(1) of this title](/usc/21/841.md?p=a-1) by distributing a [controlled substance](/usc/21/802.md?p=6) to a [person](/usc/21/379j–21.md?p=k-10) under twenty-one years of age is (except as provided in [subsection (b)](#b)) subject to (1) twice the maximum punishment [authorized](/usc/21/360eee–1.md?p=a-6) by [section 841(b) of this title](/usc/21/841.md?p=b), and (2) at least twice any term of supervised release [authorized](/usc/21/360eee–1.md?p=a-6) by [section 841(b) of this title](/usc/21/841.md?p=b), for a first offense involving the same [controlled substance](/usc/21/802.md?p=6) and schedule. Except to the extent a greater minimum sentence is otherwise provided by [section 841(b) of this title](/usc/21/841.md?p=b), a term of imprisonment under this subsection shall be not less than one year. The mandatory minimum sentencing provisions of this subsection shall not apply to offenses involving 5 grams or less of [marihuana](/usc/21/802.md?p=16-A). - (b) **Second offense—** Except as provided in [section 860 of this title](/usc/21/860.md), any [person](/usc/21/379j–21.md?p=k-10) at least eighteen years of age who violates [section 841(a)(1) of this title](/usc/21/841.md?p=a-1) by distributing a [controlled substance](/usc/21/802.md?p=6) to a [person](/usc/21/379j–21.md?p=k-10) under twenty-one years of age after a prior conviction under [subsection (a)](#a) of this section (or under [section 333(b) of this title](/usc/21/333.md?p=b) as in effect prior to May 1, 1971) has become final, is subject to (1) three times the maximum punishment [authorized](/usc/21/360eee–1.md?p=a-6) by [section 841(b) of this title](/usc/21/841.md?p=b), and (2) at least three times any term of supervised release [authorized](/usc/21/360eee–1.md?p=a-6) by [section 841(b) of this title](/usc/21/841.md?p=b), for a second or subsequent offense involving the same [controlled substance](/usc/21/802.md?p=6) and schedule. Except to the extent a greater minimum sentence is otherwise provided by [section 841(b) of this title](/usc/21/841.md?p=b), a term of imprisonment under this subsection shall be not less than one year. Penalties for third and subsequent convictions shall be governed by [section 841(b)(1)(A) of this title](/usc/21/841.md?p=b-1-A). # §860. Distribution or manufacturing in or near schools and colleges - (a) **Penalty—** Any [person](/usc/21/379j–21.md?p=k-10) who violates [section 841(a)(1) of this title](/usc/21/841.md?p=a-1) or [section 856 of this title](/usc/21/856.md) by distributing, possessing with intent to [distribute](/usc/21/802.md?p=11), or manufacturing a [controlled substance](/usc/21/802.md?p=6) in or on, or within one thousand feet of, the real property comprising a public or private elementary, vocational, or secondary school or a public or private college, junior college, or university, or a [playground](#e-1), or housing [facility](/usc/21/350g.md?p=o-2) owned by a public housing authority, or within 100 feet of a public or private [youth center](#e-2), public [swimming pool](#e-4), or [video arcade facility](#e-3), is (except as provided in [subsection (b)](#b)) subject to (1) twice the maximum punishment [authorized](/usc/21/360eee–1.md?p=a-6) by [section 841(b) of this title](/usc/21/841.md?p=b); and (2) at least twice any term of supervised release [authorized](/usc/21/360eee–1.md?p=a-6) by [section 841(b) of this title](/usc/21/841.md?p=b) for a first offense. A fine up to twice that [authorized](/usc/21/360eee–1.md?p=a-6) by [section 841(b) of this title](/usc/21/841.md?p=b) may be imposed in addition to any term of imprisonment [authorized](/usc/21/360eee–1.md?p=a-6) by this subsection. Except to the extent a greater minimum sentence is otherwise provided by [section 841(b) of this title](/usc/21/841.md?p=b), a [person](/usc/21/379j–21.md?p=k-10) shall be sentenced under this subsection to a term of imprisonment of not less than one year. The mandatory minimum sentencing provisions of this paragraph shall not apply to offenses involving 5 grams or less of [marihuana](/usc/21/802.md?p=16-A). - (b) **Second offenders—** Any [person](/usc/21/379j–21.md?p=k-10) who violates [section 841(a)(1) of this title](/usc/21/841.md?p=a-1) or [section 856 of this title](/usc/21/856.md) by distributing, possessing with intent to [distribute](/usc/21/802.md?p=11), or manufacturing a [controlled substance](/usc/21/802.md?p=6) in or on, or within one thousand feet of, the real property comprising a public or private elementary, vocational, or secondary school or a public or private college, junior college, or university, or a [playground](#e-1), or housing [facility](/usc/21/350g.md?p=o-2) owned by a public housing authority, or within 100 feet of a public or private [youth center](#e-2), public [swimming pool](#e-4), or [video arcade facility](#e-3), after a prior conviction under [subsection (a)](#a) has become final is punishable (1) by the greater of (A) a term of imprisonment of not less than three years and not more than life imprisonment or (B) three times the maximum punishment [authorized](/usc/21/360eee–1.md?p=a-6) by [section 841(b) of this title](/usc/21/841.md?p=b) for a first offense, and (2) at least three times any term of supervised release [authorized](/usc/21/360eee–1.md?p=a-6) by [section 841(b) of this title](/usc/21/841.md?p=b) for a first offense. A fine up to three times that [authorized](/usc/21/360eee–1.md?p=a-6) by [section 841(b) of this title](/usc/21/841.md?p=b) may be imposed in addition to any term of imprisonment [authorized](/usc/21/360eee–1.md?p=a-6) by this subsection. Except to the extent a greater minimum sentence is otherwise provided by [section 841(b) of this title](/usc/21/841.md?p=b), a [person](/usc/21/379j–21.md?p=k-10) shall be sentenced under this subsection to a term of imprisonment of not less than three years. Penalties for third and subsequent convictions shall be governed by [section 841(b)(1)(A) of this title](/usc/21/841.md?p=b-1-A). - (c) **Employing children to distribute drugs near schools or playgrounds—** Notwithstanding any other law, any [person](/usc/21/379j–21.md?p=k-10) at least 21 years of age who knowingly and intentionally— - (1) employs, hires, uses, persuades, induces, entices, or coerces a [person](/usc/21/379j–21.md?p=k-10) under 18 years of age to violate this section; or - (2) employs, hires, uses, persuades, induces, entices, or coerces a [person](/usc/21/379j–21.md?p=k-10) under 18 years of age to assist in avoiding detection or apprehension for any offense under this section by any Federal, [State](/usc/21/802.md?p=26), or local law enforcement official, is punishable by a term of imprisonment, a fine, or both, up to triple those [authorized](/usc/21/360eee–1.md?p=a-6) by [section 841 of this title](/usc/21/841.md). - (d) **Suspension of sentence; probation; parole—** In the case of any mandatory minimum sentence imposed under this section, imposition or execution of such sentence shall not be suspended and probation shall not be granted. An individual convicted under this section shall not be eligible for parole until the individual has served the mandatory minimum term of imprisonment as provided by this section. - (e) **Definitions—** For the purposes of this section— - (1) The term “playground” means any outdoor [facility](/usc/21/350g.md?p=o-2) (including any parking lot appurtenant thereto) intended for recreation, open to the public, and with any portion thereof containing three or more separate apparatus intended for the recreation of children including, but not limited to, sliding boards, swingsets, and teeterboards. - (2) The term “youth center” means any recreational [facility](/usc/21/350g.md?p=o-2) and/or gymnasium (including any parking lot appurtenant thereto), intended primarily for use by [persons](/usc/21/379j–21.md?p=k-10) under 18 years of age, which regularly provides athletic, civic, or cultural activities. - (3) The term “video arcade facility” means any [facility](/usc/21/350g.md?p=o-2), legally accessible to [persons](/usc/21/379j–21.md?p=k-10) under 18 years of age, intended primarily for the use of pinball and video machines for amusement containing a minimum of ten pinball and/or video machines. - (4) The term “swimming pool” includes any parking lot appurtenant thereto. # §860a. Consecutive sentence for manufacturing or distributing, or possessing with intent to manufacture or distribute, methamphetamine on premises where children are present or reside Whoever violates [section 841(a)(1) of this title](/usc/21/841.md?p=a-1) by manufacturing or distributing, or possessing with intent to [manufacture](/usc/21/802.md?p=15) or [distribute](/usc/21/802.md?p=11), methamphetamine or its salts, [isomers](/usc/21/802.md?p=14) or salts of [isomers](/usc/21/802.md?p=14) on premises in which an individual who is under the age of 18 years is present or resides, shall, in addition to any other sentence imposed, be imprisoned for a period of any term of years but not more than 20 years, subject to a fine, or both. # §861. Employment or use of persons under 18 years of age in drug operations - (a) **Unlawful acts—** It shall be unlawful for any [person](/usc/21/379j–21.md?p=k-10) at least eighteen years of age to knowingly and intentionally— - (1) employ, hire, use, persuade, induce, entice, or coerce, a [person](/usc/21/379j–21.md?p=k-10) under eighteen years of age to violate any provision of this subchapter or subchapter II; - (2) employ, hire, use, persuade, induce, entice, or coerce, a [person](/usc/21/379j–21.md?p=k-10) under eighteen years of age to assist in avoiding detection or apprehension for any offense of this subchapter or subchapter II by any Federal, [State](/usc/21/802.md?p=26), or local law enforcement official; or - (3) receive a [controlled substance](/usc/21/802.md?p=6) from a [person](/usc/21/379j–21.md?p=k-10) under 18 years of age, other than an immediate family member, in violation of this subchapter or subchapter II. - (b) **Penalty for first offense—** Any [person](/usc/21/379j–21.md?p=k-10) who violates [subsection (a)](#a) is subject to twice the maximum punishment otherwise [authorized](/usc/21/360eee–1.md?p=a-6) and at least twice any term of supervised release otherwise [authorized](/usc/21/360eee–1.md?p=a-6) for a first offense. Except to the extent a greater minimum sentence is otherwise provided, a term of imprisonment under this subsection shall not be less than one year. - (c) **Penalty for subsequent offenses—** Any [person](/usc/21/379j–21.md?p=k-10) who violates [subsection (a)](#a) after a prior conviction under [subsection (a)](#a) of this section has become final, is subject to three times the maximum punishment otherwise [authorized](/usc/21/360eee–1.md?p=a-6) and at least three times any term of supervised release otherwise [authorized](/usc/21/360eee–1.md?p=a-6) for a first offense. Except to the extent a greater minimum sentence is otherwise provided, a term of imprisonment under this subsection shall not be less than one year. Penalties for third and subsequent convictions shall be governed by [section 841(b)(1)(A) of this title](/usc/21/841.md?p=b-1-A). - (d) **Penalty for providing or distributing controlled substance to underage person—** Any [person](/usc/21/379j–21.md?p=k-10) who violates subsection [(a)(1)](#a-1) or [(2)](#a-2)[^1] - (1) by knowingly providing or distributing a [controlled substance](/usc/21/802.md?p=6) or a [controlled substance analogue](/usc/21/802.md?p=32-A) to any [person](/usc/21/379j–21.md?p=k-10) under eighteen years of age; or - (2) if the [person](/usc/21/379j–21.md?p=k-10) employed, hired, or used is fourteen years of age or younger, shall be subject to a term of imprisonment for not more than five years or a fine of not more than $50,000, or both, in addition to any other punishment [authorized](/usc/21/360eee–1.md?p=a-6) by this section. - (e) **Suspension of sentence; probation; parole—** In any case of any sentence imposed under this section, imposition or execution of such sentence shall not be suspended and probation shall not be granted. An individual convicted under this section of an offense for which a mandatory minimum term of imprisonment is applicable shall not be eligible for parole under [section 4202 of title 18](https://uscode.house.gov/view.xhtml?req=(/us/usc/t18/s4202))[^2] until the individual has served the mandatory term of imprisonment as enhanced by this section. - (f) **Distribution of controlled substance to pregnant individual—** Except as [authorized](/usc/21/360eee–1.md?p=a-6) by this subchapter, it shall be unlawful for any [person](/usc/21/379j–21.md?p=k-10) to knowingly or intentionally provide or [distribute](/usc/21/802.md?p=11) any [controlled substance](/usc/21/802.md?p=6) to a pregnant individual in violation of any provision of this subchapter. Any [person](/usc/21/379j–21.md?p=k-10) who violates this subsection shall be subject to the provisions of subsections [(b)](#b), [(c)](#c), and [(e)](#e). # §862. Denial of Federal benefits to drug traffickers and possessors - (a) **Drug traffickers—** - (1) Any individual who is convicted of any Federal or [State](/usc/21/802.md?p=26) offense consisting of the [distribution](/usc/21/360eee.md?p=5) of [controlled substances](/usc/21/802.md?p=6) shall— - (A) at the discretion of the court, upon the first conviction for such an offense be ineligible for any or all [Federal benefits](#d-1) for up to 5 years after such conviction; - (B) at the discretion of the court, upon a second conviction for such an offense be ineligible for any or all [Federal benefits](#d-1) for up to 10 years after such conviction; and - (C) upon a third or subsequent conviction for such an offense be permanently ineligible for all [Federal benefits](#d-1). - (2) The benefits which are denied under this subsection shall not include benefits relating to long-term [drug](/usc/21/321.md?p=g-1) treatment [programs](/usc/21/1523.md?p=8) for addiction for any [person](/usc/21/379j–21.md?p=k-10) who, if there is a reasonable body of evidence to substantiate such declaration, declares himself to be an [addict](/usc/21/802.md?p=1) and submits himself to a long-term treatment [program](/usc/21/1523.md?p=8) for addiction, or is deemed to be rehabilitated pursuant to rules established by the [Secretary](/usc/21/802.md?p=24) of Health and Human Services. - (b) **Drug possessors—** - (1) Any individual who is convicted of any Federal or [State](/usc/21/802.md?p=26) offense involving the possession of a [controlled substance](/usc/21/802.md?p=6) (as such term is defined for purposes of this subchapter) shall— - (A) upon the first conviction for such an offense and at the discretion of the court— - (i) be ineligible for any or all [Federal benefits](#d-1) for up to one year; - (ii) be required to successfully complete an approved [drug](/usc/21/321.md?p=g-1) treatment [program](/usc/21/1523.md?p=8) which includes periodic testing to insure that the individual remains [drug](/usc/21/321.md?p=g-1) free; - (iii) be required to perform appropriate community service; or - (iv) any combination of clause [(i)](#b-1-A-i), [(ii)](#b-1-A-ii), or [(iii)](#b-1-A-iii); and - (B) upon a second or subsequent conviction for such an offense be ineligible for all [Federal benefits](#d-1) for up to 5 years after such conviction as determined by the court. The court shall continue to have the discretion in [subparagraph (A)](#b-1-A) above. In imposing penalties and conditions under [subparagraph (A)](#b-1-A), the court may require that the completion of the conditions imposed by clause [(ii)](#b-1-A-ii) or [(iii)](#b-1-A-iii) be a requirement for the reinstatement of benefits under [clause (i)](#b-1-A-i). - (2) The penalties and conditions which may be imposed under this subsection shall be waived in the case of a [person](/usc/21/379j–21.md?p=k-10) who, if there is a reasonable body of evidence to substantiate such declaration, declares himself to be an [addict](/usc/21/802.md?p=1) and submits himself to a long-term treatment [program](/usc/21/1523.md?p=8) for addiction, or is deemed to be rehabilitated pursuant to rules established by the [Secretary](/usc/21/802.md?p=24) of Health and Human Services. - (c) **Suspension of period of ineligibility—** The period of ineligibility referred to in subsections [(a)](#a) and [(b)](#b) shall be suspended if the individual— - (A) completes a supervised [drug](/usc/21/321.md?p=g-1) rehabilitation [program](/usc/21/1523.md?p=8) after becoming ineligible under this section; - (B) has otherwise been rehabilitated; or - (C) has made a good faith effort to gain admission to a supervised [drug](/usc/21/321.md?p=g-1) rehabilitation [program](/usc/21/1523.md?p=8), but is unable to do so because of inaccessibility or unavailability of such a [program](/usc/21/1523.md?p=8), or the inability of the individual to pay for such a [program](/usc/21/1523.md?p=8). - (d) **Definitions—** As used in this section— - (1) the term “Federal benefit”— - (A) means the issuance of any grant, contract, loan, professional license, or commercial license provided by an agency of the [United States](/usc/21/802.md?p=28) or by appropriated funds of the [United States](/usc/21/802.md?p=28); and - (B) does not include any retirement, welfare, Social Security, health, disability, [veterans benefit](#d-2), public housing, or other similar benefit, or any other benefit for which payments or services are required for eligibility; and - (2) the term “veterans benefit” means all benefits provided to veterans, their families, or survivors by virtue of the service of a veteran in the Armed Forces of the [United States](/usc/21/802.md?p=28). - (e) **Inapplicability of this section to Government witnesses—** The penalties provided by this section shall not apply to any individual who cooperates or testifies with the Government in the prosecution of a Federal or [State](/usc/21/802.md?p=26) offense or who is in a Government witness protection [program](/usc/21/1523.md?p=8). - (f) **Indian provision—** Nothing in this section shall be construed to affect the obligation of the [United States](/usc/21/802.md?p=28) to any Indian or Indian tribe arising out of any treaty, statute, Executive order, or the trust responsibility of the [United States](/usc/21/802.md?p=28) owing to such Indian or Indian tribe. Nothing in this subsection shall exempt any individual Indian from the sanctions provided for in this section, provided that no individual Indian shall be denied any benefit under Federal Indian [programs](/usc/21/1523.md?p=8) comparable to those described in subsection [(d)(1)(B)](#d-1-B) or [(d)(2)](#d-2). - (g) **Presidential report—** - (1) On or before May 1, 1989, the President shall transmit to the Congress a report— - (A) delineating the role of [State](/usc/21/802.md?p=26) courts in implementing this section; - (B) describing the manner in which Federal agencies will implement and enforce the requirements of this section; - (C) detailing the means by which Federal and [State](/usc/21/802.md?p=26) agencies, courts, and law enforcement agencies will exchange and share the data and information necessary to implement and enforce the withholding of [Federal benefits](#d-1); and - (D) recommending any modifications to improve the administration of this section or otherwise achieve the goal of discouraging the [trafficking](/usc/21/2341.md?p=4) and possession of [controlled substances](/usc/21/802.md?p=6). - (2) No later than September 1, 1989, the Congress shall consider the report of the President and enact such changes as it deems appropriate to further the goals of this section. - (h) **Effective date—** The denial of [Federal benefits](#d-1) set forth in this section shall take effect for convictions occurring after September 1, 1989. # §862a. Denial of assistance and benefits for certain drug-related convictions - (a) **In general—** An individual convicted (under Federal or [State](#e) law) of any offense which is classified as a [felony](/usc/21/802.md?p=13) by the law of the jurisdiction involved and which has as an element the possession, use, or [distribution](/usc/21/360eee.md?p=5) of a [controlled substance](/usc/21/802.md?p=6) (as defined in [section 802(6) of this title](/usc/21/802.md?p=6)) shall not be eligible for— - (1) assistance under any [State](#e) [program](/usc/21/1523.md?p=8) funded under part A of title IV of the Social Security Act [[42 U.S.C. 601](/usc/42/601.md) et seq.], or - (2) benefits under the supplemental nutrition assistance [program](/usc/21/1523.md?p=8) (as defined in section 3 of the [Food](/usc/21/346a.md?p=a-1) and Nutrition Act of 2008 ([7 U.S.C. 2012](/usc/7/2012.md))) or any [State](#e) [program](/usc/21/1523.md?p=8) carried out under that Act [[7 U.S.C. 2011](/usc/7/2011.md) et seq.]. - (b) **Effects on assistance and benefits for others—** - (1) **Program of temporary assistance for needy families—** The amount of assistance otherwise required to be provided under a [State](#e) [program](/usc/21/1523.md?p=8) funded under part A of title IV of the Social Security Act [[42 U.S.C. 601](/usc/42/601.md) et seq.] to the family members of an individual to whom [subsection (a)](#a) applies shall be reduced by the amount which would have otherwise been made available to the individual under such part. - (2) **Benefits under the Food and Nutrition Act of 2008—** The amount of benefits otherwise required to be provided to a household under the supplemental nutrition assistance [program](/usc/21/1523.md?p=8) (as defined in section 3 of the [Food](/usc/21/346a.md?p=a-1) and Nutrition Act of 2008 ([7 U.S.C. 2012](/usc/7/2012.md))), or any [State](#e) [program](/usc/21/1523.md?p=8) carried out under that Act [[7 U.S.C. 2011](/usc/7/2011.md) et seq.], shall be determined by considering the individual to whom [subsection (a)](#a) applies not to be a member of such household, except that the income and resources of the individual shall be considered to be income and resources of the household. - (c) **Enforcement—** A [State](#e) that has not exercised its authority under [subsection (d)(1)(A)](#d-1-A) shall require each individual applying for assistance or benefits referred to in [subsection (a)](#a), during the application process, to [state](#e), in writing, whether the individual, or any member of the household of the individual, has been convicted of a crime described in [subsection (a)](#a). - (d) **Limitations—** - (1) **State elections—** - (A) **Opt out—** A [State](#e) may, by specific reference in a law enacted after August 22, 1996, exempt any or all individuals domiciled in the [State](#e) from the application of [subsection (a)](#a). - (B) **Limit period of prohibition—** A [State](#e) may, by law enacted after August 22, 1996, limit the period for which [subsection (a)](#a) shall apply to any or all individuals domiciled in the [State](#e). - (2) **Inapplicability to convictions occurring on or before August 22, 1996—** [Subsection (a)](#a) shall not apply to a conviction if the conviction is for conduct occurring on or before August 22, 1996. - (e) **“State” defined—** For purposes of this section, the term “State” has the meaning given it— - (1) in section 419(5) of the Social Security Act [[42 U.S.C. 619(5)](/usc/42/619.md?p=5)], when referring to assistance provided under a [State](#e) [program](/usc/21/1523.md?p=8) funded under part A of title IV of the Social Security Act [[42 U.S.C. 601](/usc/42/601.md) et seq.], and - (2) in section 3 of the [Food](/usc/21/346a.md?p=a-1) and Nutrition Act of 2008 ([7 U.S.C. 2012](/usc/7/2012.md)), when referring to the supplemental nutrition assistance [program](/usc/21/1523.md?p=8) (as defined in that section) or any [State](#e) [program](/usc/21/1523.md?p=8) carried out under that Act [[7 U.S.C. 2011](/usc/7/2011.md) et seq.]. - (f) **Rule of interpretation—** Nothing in this section shall be construed to deny the following Federal benefits: - (1) Emergency medical services under title XIX of the Social Security Act [[42 U.S.C. 1396](/usc/42/1396.md) et seq.]. - (2) Short-term, noncash, in-kind emergency disaster relief. - (3) - (A) Public health assistance for immunizations. - (B) Public health assistance for testing and treatment of communicable diseases if the [Secretary](/usc/21/802.md?p=24) of Health and Human Services determines that it is necessary to prevent the spread of such disease. - (4) Prenatal care. - (5) Job training [programs](/usc/21/1523.md?p=8). - (6) [Drug](/usc/21/321.md?p=g-1) treatment [programs](/usc/21/1523.md?p=8). # §862b. Sanctioning for testing positive for controlled substances Notwithstanding any other provision of law, [States](/usc/21/802.md?p=26) shall not be prohibited by the Federal Government from testing welfare recipients for use of [controlled substances](/usc/21/802.md?p=6) nor from sanctioning welfare recipients who test positive for use of [controlled substances](/usc/21/802.md?p=6). # §863. Drug paraphernalia - (a) **In general—** It is unlawful for any [person](/usc/21/379j–21.md?p=k-10)— - (1) to sell or offer for sale [drug paraphernalia](#d); - (2) to use the mails or any other [facility](/usc/21/350g.md?p=o-2) of interstate commerce to transport [drug paraphernalia](#d); or - (3) to import or export [drug paraphernalia](#d). - (b) **Penalties—** Anyone convicted of an offense under [subsection (a)](#a) of this section shall be imprisoned for not more than three years and fined under [title 18](/usc/18.md). - (c) **Seizure and forfeiture—** Any [drug paraphernalia](#d) involved in any violation of [subsection (a)](#a) of this section shall be subject to seizure and forfeiture upon the conviction of a [person](/usc/21/379j–21.md?p=k-10) for such violation. Any such paraphernalia shall be delivered to the [Administrator](/usc/21/1523.md?p=1) of General Services, General Services Administration, who may order such paraphernalia destroyed or may authorize its use for law enforcement or educational purposes by Federal, [State](/usc/21/802.md?p=26), or local authorities. - (d) **“Drug paraphernalia” defined—** The term “drug paraphernalia” means any equipment, product, or material of any kind which is primarily intended or designed for use in manufacturing, compounding, converting, concealing, producing, processing, preparing, injecting, ingesting, inhaling, or otherwise introducing into the human body a [controlled substance](/usc/21/802.md?p=6), possession of which is unlawful under this subchapter. It includes items primarily intended or designed for use in ingesting, inhaling, or otherwise introducing [marijuana](/usc/21/802.md?p=16-A),[^1] cocaine, hashish, hashish oil, PCP, methamphetamine, or amphetamines into the human body, such as— - (1) metal, wooden, acrylic, glass, stone, plastic, or ceramic pipes with or without screens, permanent screens, hashish heads, or punctured metal bowls; - (2) water pipes; - (3) carburetion tubes and [devices](/usc/21/355–2.md?p=a-3); - (4) smoking and carburetion masks; - (5) roach clips: meaning objects used to hold burning material, such as a [marihuana](/usc/21/802.md?p=16-A) cigarette, that has become too small or too short to be held in the hand; - (6) miniature spoons with level capacities of one-tenth cubic centimeter or less; - (7) chamber pipes; - (8) carburetor pipes; - (9) electric pipes; - (10) air-driven pipes; - (11) chillums; - (12) bongs; - (13) ice pipes or chillers; - (14) wired cigarette papers; or - (15) cocaine freebase kits. - (e) **Matters considered in determination of what constitutes drug paraphernalia—** In determining whether an item constitutes [drug paraphernalia](#d), in addition to all other logically relevant factors, the following may be considered: - (1) instructions, oral or written, provided with the item concerning its use; - (2) descriptive materials accompanying the item which explain or depict its use; - (3) national and local advertising concerning its use; - (4) the manner in which the item is displayed for sale; - (5) whether the owner, or anyone in [control](/usc/21/802.md?p=5) of the item, is a legitimate supplier of like or related items to the community, such as a [licensed](/usc/21/360eee–1.md?p=a-6) [distributor](/usc/21/802.md?p=11) or dealer of [tobacco products](/usc/21/321.md?p=rr-2); - (6) direct or circumstantial evidence of the ratio of sales of the item(s) to the total sales of the business enterprise; - (7) the existence and scope of legitimate uses of the item in the community; and - (8) expert testimony concerning its use. - (f) **Exemptions—** This section shall not apply to— - (1) any [person](/usc/21/379j–21.md?p=k-10) [authorized](/usc/21/360eee–1.md?p=a-6) by local, [State](/usc/21/802.md?p=26), or Federal law to [manufacture](/usc/21/802.md?p=15), possess, or [distribute](/usc/21/802.md?p=11) such items; or - (2) any item that, in the normal lawful course of business, is imported, exported, transported, or sold through the mail or by any other means, and traditionally intended for use with [tobacco products](/usc/21/321.md?p=rr-2), including any pipe, paper, or accessory. # §864. Anhydrous ammonia - (a) It is unlawful for any [person](/usc/21/379j–21.md?p=k-10)— - (1) to steal anhydrous ammonia, or - (2) to transport stolen anhydrous ammonia across [State](/usc/21/802.md?p=26) lines, knowing, intending, or having reasonable cause to believe that such anhydrous ammonia will be used to [manufacture](/usc/21/802.md?p=15) a [controlled substance](/usc/21/802.md?p=6) in violation of this part. - (b) Any [person](/usc/21/379j–21.md?p=k-10) who violates [subsection (a)](#a) shall be imprisoned or fined, or both, in accordance with [section 843(d) of this title](/usc/21/843.md?p=d) as if such violation were a violation of a provision of [section 843 of this title](/usc/21/843.md). # §864a. Grants to reduce production of methamphetamines from anhydrous ammonia - (a) **Definitions—** In this section: - (1) **Eligible entity—** The term “eligible entity” means— - (A) a producer of agricultural commodities; - (B) a cooperative association, a majority of the members of which produce or process agricultural commodities; or - (C) a [person](/usc/21/379j–21.md?p=k-10) in the trade or business of— - (i) selling an agricultural product (including an agricultural chemical) [at retail](/usc/21/802.md?p=48), predominantly to farmers and ranchers; or - (ii) aerial and ground application of an agricultural chemical. - (2) **Nurse tank—** The term “nurse tank” shall be considered to be a cargo tank (within the meaning of [section 173.315(m) of title 49, Code of Federal Regulations](/cfr/49/173.315.md?p=m), as in effect as of the date of the enactment of this Act). - (b) **Grant authority—** The [Secretary](/usc/21/802.md?p=24) may make a grant to an [eligible entity](#a-1) to enable the [eligible entity](#a-1) to obtain and add to an anhydrous ammonia fertilizer [nurse tank](#a-2) a physical lock or a substance to reduce the amount of methamphetamine that can be produced from any anhydrous ammonia removed from the [nurse tank](#a-2). - (c) **Grant amount—** The amount of a grant made under this section to an [eligible entity](#a-1) shall be the product obtained by multiplying— - (1) an amount not less than $40 and not more than $60, as determined by the [Secretary](/usc/21/802.md?p=24); and - (2) the number of fertilizer [nurse tanks](#a-2) of the [eligible entity](#a-1). - (d) **Authorization of appropriations—** There is [authorized](/usc/21/360eee–1.md?p=a-6) to be appropriated to the [Secretary](/usc/21/802.md?p=24) to make grants under this section $15,000,000 for the period of fiscal years 2008 through 2012. # §865. Smuggling methamphetamine or methamphetamine precursor chemicals into the United States while using facilitated entry programs - (a) **Enhanced prison sentence—** The sentence of imprisonment imposed on a [person](/usc/21/379j–21.md?p=k-10) convicted of an offense under the Controlled Substances Act ([21 U.S.C. 801](/usc/21/801.md) et seq.) or the [Controlled Substances](/usc/21/802.md?p=6) Import and Export Act ([21 U.S.C. 951](/usc/21/951.md) et seq.), involving methamphetamine or any [listed chemical](/usc/21/802.md?p=33) that is defined in section 102(33) of the Controlled Substances Act ([21 U.S.C. 802(33)](/usc/21/802.md?p=33),[^1] shall, if the offense is committed under the circumstance described in [subsection (b)](#b), be increased by a consecutive term of imprisonment of not more than 15 years. - (b) **Circumstances—** For purposes of [subsection (a)](#a), the circumstance described in this subsection is that the offense described in [subsection (a)](#a) was committed by a [person](/usc/21/379j–21.md?p=k-10) who— - (1) was enrolled in, or who was acting on behalf of any [person](/usc/21/379j–21.md?p=k-10) or entity enrolled in, any dedicated commuter lane, alternative or accelerated inspection system, or other facilitated entry [program](/usc/21/1523.md?p=8) administered or approved by the Federal Government for use in entering the [United States](/usc/21/802.md?p=28); and - (2) committed the offense while entering the [United States](/usc/21/802.md?p=28), using such lane, system, or [program](/usc/21/1523.md?p=8). - (c) **Permanent ineligibility—** Any [person](/usc/21/379j–21.md?p=k-10) whose term of imprisonment is increased under [subsection (a)](#a) shall be permanently and irrevocably barred from being eligible for or using any lane, system, or [program](/usc/21/1523.md?p=8) described in [subsection (b)(1)](#b-1). # §871. Attorney General - (a) **Delegation of functions—** The Attorney General may delegate any of his functions under this subchapter to any officer or employee of the Department of Justice. - (b) **Rules and regulations—** The Attorney General may promulgate and enforce any rules, regulations, and procedures which he may deem necessary and appropriate for the efficient execution of his functions under this subchapter. - (c) **Acceptance of devises, bequests, gifts, and donations—** The Attorney General may accept in the name of the Department of Justice any form of devise, bequest, gift, or donation where the donor intends to donate property for the purpose of preventing or controlling the abuse of [controlled substances](/usc/21/802.md?p=6). He may take all appropriate steps to secure possession of such property and may sell, assign, transfer, or convey any such property other than moneys. # §871a. Semiannual reports to Congress - (a) **In general—** The Attorney General shall, on a semiannual basis, submit to the congressional committees and organizations specified in [subsection (b)](#b) reports that— - (1) describe the allocation of the resources of the [Drug Enforcement Administration](/usc/21/802.md?p=4) and the Federal Bureau of Investigation for the investigation and prosecution of alleged violations of the Controlled Substances Act [[21 U.S.C. 801](/usc/21/801.md) et seq.] involving methamphetamine; and - (2) the measures being taken to give priority in the allocation of such resources to such violations involving— - (A) [persons](/usc/21/379j–21.md?p=k-10) alleged to have imported into the [United States](/usc/21/802.md?p=28) substantial quantities of methamphetamine or scheduled [listed chemicals](/usc/21/802.md?p=33) (as defined pursuant to the amendment made by section 711(a)(1));[^1] - (B) [persons](/usc/21/379j–21.md?p=k-10) alleged to have manufactured methamphetamine; and - (C) circumstances in which the violations have endangered children. - (b) **Congressional committees—** The congressional committees and organizations referred to in [subsection (a)](#a) are— - (1) in the House of Representatives, the Committee on the Judiciary, the Committee on Energy and Commerce, and the Committee on Government Reform; and - (2) in the Senate, the Committee on the Judiciary, the Committee on Commerce, Science, and Transportation, and the Caucus on International Narcotics [Control](/usc/21/802.md?p=5). # §872. Education and research programs of Attorney General - (a) **Authorization—** The Attorney General is [authorized](/usc/21/360eee–1.md?p=a-6) to carry out educational and research [programs](/usc/21/1523.md?p=8) directly related to enforcement of the laws under his jurisdiction concerning [drugs](/usc/21/321.md?p=g-1) or other substances which are or may be subject to [control](/usc/21/802.md?p=5) under this subchapter. Such [programs](/usc/21/1523.md?p=8) may include— - (1) educational and training [programs](/usc/21/1523.md?p=8) on [drug](/usc/21/321.md?p=g-1) abuse and [controlled substances](/usc/21/802.md?p=6) law enforcement for local, [State](/usc/21/802.md?p=26), tribal, and Federal personnel; - (2) studies or special projects designed to compare the deterrent effects of various enforcement [strategies](/usc/21/1701.md?p=12) on [drug](/usc/21/321.md?p=g-1) use and abuse; - (3) studies or special projects designed to assess and detect accurately the presence in the human body of [drugs](/usc/21/321.md?p=g-1) or other substances which are or may be subject to [control](/usc/21/802.md?p=5) under this subchapter, including the development of rapid field identification methods which would enable [agents](/usc/21/802.md?p=3) to detect microquantities of such [drugs](/usc/21/321.md?p=g-1) or other substances; - (4) studies or special projects designed to evaluate the nature and sources of the supply of illegal [drugs](/usc/21/321.md?p=g-1) throughout the country; - (5) studies or special projects to develop more effective methods to prevent diversion of [controlled substances](/usc/21/802.md?p=6) into illegal channels; and - (6) studies or special projects to develop information necessary to carry out his functions under [section 811 of this title](/usc/21/811.md). - (b) **Contracts—** The Attorney General may enter into contracts for such educational and research activities without performance bonds and without regard to [section 6101 of title 41](/usc/41/6101.md). - (c) **Identification of research populations; authorization to withhold—** The Attorney General may authorize [persons](/usc/21/379j–21.md?p=k-10) engaged in research to withhold the names and other identifying characteristics of [persons](/usc/21/379j–21.md?p=k-10) who are the subjects of such research. [Persons](/usc/21/379j–21.md?p=k-10) who obtain this authorization may not be compelled in any Federal, [State](/usc/21/802.md?p=26), tribal, or local civil, criminal, administrative, legislative, or other proceeding to identify the subjects of research for which such authorization was obtained. - (d) **Affect of treaties and other international agreements on confidentiality—** Nothing in the [Single Convention on Narcotic Drugs](/usc/21/802.md?p=31), the [Convention on Psychotropic Substances](/usc/21/802.md?p=31), or other treaties or international agreements shall be construed to limit, modify, or prevent the protection of the confidentiality of patient records or of the names and other identifying characteristics of research subjects as provided by any Federal, [State](/usc/21/802.md?p=26), or local law or regulation. - (e) **Use of controlled substances in research—** The Attorney General, on his own motion or at the request of the [Secretary](/usc/21/802.md?p=24), may authorize the possession, [distribution](/usc/21/360eee.md?p=5), and dispensing of [controlled substances](/usc/21/802.md?p=6) by [persons](/usc/21/379j–21.md?p=k-10) engaged in research. [Persons](/usc/21/379j–21.md?p=k-10) who obtain this authorization shall be exempt from [State](/usc/21/802.md?p=26) or Federal prosecution for possession, [distribution](/usc/21/360eee.md?p=5), and dispensing of [controlled substances](/usc/21/802.md?p=6) to the extent [authorized](/usc/21/360eee–1.md?p=a-6) by the Attorney General. - (f) **Program to curtail diversion of precursor and essential chemicals—** The Attorney General shall maintain an active [program](/usc/21/1523.md?p=8), both domestic and international, to curtail the diversion of precursor chemicals and essential chemicals used in the illicit [manufacture](/usc/21/802.md?p=15) of [controlled substances](/usc/21/802.md?p=6). # §872a. Public-private education program - (a) **Advisory panel—** The Attorney General shall establish an advisory panel consisting of an appropriate number of representatives from Federal, [State](/usc/21/802.md?p=26), tribal, and local law enforcement and regulatory agencies with experience in investigating and prosecuting illegal transactions of precursor chemicals. The Attorney General shall convene the panel as often as necessary to develop and coordinate educational [programs](/usc/21/1523.md?p=8) for wholesale and [retail distributors](/usc/21/802.md?p=49-A) of precursor chemicals and supplies. - (b) **Continuation of current efforts—** The Attorney General shall continue to— - (1) maintain an active [program](/usc/21/1523.md?p=8) of seminars and training to educate wholesale and [retail distributors](/usc/21/802.md?p=49-A) of precursor chemicals and supplies regarding the identification of suspicious transactions and their responsibility to report such transactions; and - (2) provide assistance to [State](/usc/21/802.md?p=26), tribal, and local law enforcement and regulatory agencies to facilitate the establishment and maintenance of educational [programs](/usc/21/1523.md?p=8) for [distributors](/usc/21/802.md?p=11) of precursor chemicals and supplies. # §873. Cooperative arrangements - (a) **Cooperation of Attorney General with local, State, tribal, and Federal agencies—** The Attorney General shall cooperate with local, [State](/usc/21/802.md?p=26), tribal, and Federal agencies concerning traffic in [controlled substances](/usc/21/802.md?p=6) and in suppressing the abuse of [controlled substances](/usc/21/802.md?p=6). To this end, he is [authorized](/usc/21/360eee–1.md?p=a-6) to— - (1) arrange for the exchange of information between governmental officials concerning the use and abuse of [controlled substances](/usc/21/802.md?p=6); - (2) cooperate in the institution and prosecution of cases in the courts of the [United States](/usc/21/802.md?p=28) and before the licensing boards and courts of the several [States](/usc/21/802.md?p=26); - (3) conduct training [programs](/usc/21/1523.md?p=8) on [controlled substance](/usc/21/802.md?p=6) law enforcement for local, [State](/usc/21/802.md?p=26), tribal, and Federal personnel; - (4) maintain in the Department of Justice a unit which will accept, catalog, file, and otherwise utilize all information and statistics, including records of [controlled substance](/usc/21/802.md?p=6) abusers and other [controlled substance](/usc/21/802.md?p=6) law offenders, which may be received from Federal, [State](/usc/21/802.md?p=26), tribal, and local agencies, and make such information available for Federal, [State](/usc/21/802.md?p=26), tribal, and local law enforcement purposes; - (5) conduct [programs](/usc/21/1523.md?p=8) of eradication aimed at destroying wild or illicit growth of plant species from which [controlled substances](/usc/21/802.md?p=6) may be extracted; - (6) assist [State](/usc/21/802.md?p=26), tribal, and local governments in suppressing the diversion of [controlled substances](/usc/21/802.md?p=6) from legitimate medical, scientific, and commercial channels by— - (A) making periodic assessments of the capabilities of [State](/usc/21/802.md?p=26), tribal, and local governments to adequately [control](/usc/21/802.md?p=5) the diversion of [controlled substances](/usc/21/802.md?p=6); - (B) providing advice and counsel to [State](/usc/21/802.md?p=26), tribal, and local governments on the methods by which such governments may strengthen their [controls](/usc/21/802.md?p=5) against diversion; and - (C) establishing cooperative investigative efforts to [control](/usc/21/802.md?p=5) diversion; and - (7) notwithstanding any other provision of law, enter into contractual agreements with [State](/usc/21/802.md?p=26), tribal, and local law enforcement agencies to provide for cooperative enforcement and regulatory activities under this chapter.[^1] - (b) **Requests by Attorney General for assistance from Federal agencies or instrumentalities—** When requested by the Attorney General, it shall be the duty of any agency or instrumentality of the Federal Government to furnish assistance, including technical advice, to him for carrying out his functions under this subchapter; except that no such agency or instrumentality shall be required to furnish the name of, or other identifying information about, a patient or research subject whose identity it has undertaken to keep confidential. - (c) **Descriptive and analytic reports; limitation on court challenges—** - (1) The Attorney General shall, once every 6 months, prepare and make available to regulatory, licensing, attorneys general, and law enforcement agencies of [States](/usc/21/802.md?p=26) a standardized report containing descriptive and analytic information on the actual [distribution](/usc/21/360eee.md?p=5) patterns, as gathered through the Automated Reports and Consolidated Orders System, or any subsequent automated system, pursuant to [section 827 of this title](/usc/21/827.md) and which includes detailed amounts, outliers, and trends of [distributor](/usc/21/802.md?p=11) and pharmacy registrants, in such [States](/usc/21/802.md?p=26) for the [controlled substances](/usc/21/802.md?p=6) contained in schedule II, which, in the discretion of the Attorney General, are determined to have the highest abuse. - (2) If the Attorney General publishes the report described in [paragraph (1)](#c-1) once every 6 months as required under [paragraph (1)](#c-1), nothing in this subsection shall be construed to bring an action in any court to challenge the sufficiency of the information or to compel the Attorney General to produce any documents or reports referred to in this subsection. - (d) **Grants by Attorney General—** - (1) The Attorney General may make grants, in accordance with [paragraph (2)](#d-2), to [State](/usc/21/802.md?p=26), tribal, and local governments to assist in meeting the costs of— - (A) collecting and analyzing data on the diversion of [controlled substances](/usc/21/802.md?p=6), - (B) conducting investigations and prosecutions of such diversions, - (C) improving regulatory [controls](/usc/21/802.md?p=5) and other authorities to [control](/usc/21/802.md?p=5) such diversions, - (D) [programs](/usc/21/1523.md?p=8) to prevent such diversions, - (E) preventing and detecting forged prescriptions, and - (F) training law enforcement and regulatory personnel to improve the [control](/usc/21/802.md?p=5) of such diversions. - (2) No grant may be made under [paragraph (1)](#d-1) unless an application therefor is submitted to the Attorney General in such form and manner as the Attorney General may prescribe. No grant may exceed 80 per centum of the costs for which the grant is made, and no grant may be made unless the recipient of the grant provides assurances satisfactory to the Attorney General that it will obligate funds to meet the remaining 20 per centum of such costs. The Attorney General shall review the activities carried out with grants under [paragraph (1)](#d-1) and shall report annually to Congress on such activities. - (3) To carry out this subsection there is [authorized](/usc/21/360eee–1.md?p=a-6) to be appropriated $6,000,000 for fiscal year 1985 and $6,000,000 for fiscal year 1986. # §874. Advisory committees The Attorney General may from time to time appoint committees to advise him with respect to preventing and controlling the abuse of [controlled substances](/usc/21/802.md?p=6). Members of the committees may be entitled to receive compensation at the rate of $100 for each day (including traveltime) during which they are engaged in the actual performance of duties. While traveling on official business in the performance of duties for the committees, members of the committees shall be allowed expenses of travel, including per diem instead of subsistence, in accordance with subchapter I of [chapter 57](/usc/5/chptIII-sptD-ch57.md) of title 5. # §875. Administrative hearings - (a) **Power of Attorney General—** In carrying out his functions under this subchapter, the Attorney General may hold hearings, sign and issue subpenas, [administer](/usc/21/802.md?p=2) oaths, examine witnesses, and receive evidence at any place in the [United States](/usc/21/802.md?p=28). - (b) **Procedures applicable—** Except as otherwise provided in this subchapter, notice shall be given and hearings shall be conducted under appropriate procedures of subchapter II of [chapter 5](/usc/5/chptI-ch5.md) of title 5. # §876. Subpenas - (a) **Authorization of use by Attorney General—** In any investigation relating to his functions under this subchapter with respect to [controlled substances](/usc/21/802.md?p=6), [listed chemicals](/usc/21/802.md?p=33), tableting machines, or encapsulating machines, the Attorney General may subpena witnesses, compel the attendance and testimony of witnesses, and require the [production](/usc/21/802.md?p=22) of any records (including books, papers, documents, and other tangible things which constitute or contain evidence) which the Attorney General finds relevant or material to the investigation. The attendance of witnesses and the [production](/usc/21/802.md?p=22) of records may be required from any place in any [State](/usc/21/802.md?p=26) or in any [territory](/usc/21/387.md?p=19) or other place subject to the jurisdiction of the [United States](/usc/21/802.md?p=28) at any designated place of hearing; except that a witness shall not be required to appear at any hearing more than 500 miles distant from the place where he was served with a subpena. Witnesses summoned under this section shall be paid the same fees and mileage that are paid witnesses in the courts of the [United States](/usc/21/802.md?p=28). - (b) **Service—** A subpena issued under this section may be served by any [person](/usc/21/379j–21.md?p=k-10) designated in the subpena to serve it. Service upon a natural [person](/usc/21/379j–21.md?p=k-10) may be made by personal [delivery](/usc/21/802.md?p=8) of the subpena to him. Service may be made upon a domestic or foreign corporation or upon a partnership or other unincorporated association which is subject to suit under a common name, by delivering the subpena to an officer, to a managing or general [agent](/usc/21/802.md?p=3), or to any other [agent](/usc/21/802.md?p=3) [authorized](/usc/21/360eee–1.md?p=a-6) by appointment or by law to receive service of process. The affidavit of the [person](/usc/21/379j–21.md?p=k-10) serving the subpena entered on a true copy thereof by the [person](/usc/21/379j–21.md?p=k-10) serving it shall be proof of service. - (c) **Enforcement—** In the case of contumacy by or refusal to obey a subpena issued to any [person](/usc/21/379j–21.md?p=k-10), the Attorney General may invoke the aid of any court of the [United States](/usc/21/802.md?p=28) within the jurisdiction of which the investigation is carried on or of which the subpenaed [person](/usc/21/379j–21.md?p=k-10) is an inhabitant, or in which he carries on business or may be found, to compel compliance with the subpena. The court may issue an order requiring the subpenaed [person](/usc/21/379j–21.md?p=k-10) to appear before the Attorney General to produce records, if so ordered, or to give testimony touching the matter under investigation. Any failure to obey the order of the court may be punished by the court as a contempt thereof. All process in any such case may be served in any judicial district in which such [person](/usc/21/379j–21.md?p=k-10) may be found. # §877. Judicial review All final determinations, findings, and conclusions of the Attorney General under this subchapter shall be final and conclusive decisions of the matters involved, except that any [person](/usc/21/379j–21.md?p=k-10) aggrieved by a final decision of the Attorney General may obtain review of the decision in the [United States](/usc/21/802.md?p=28) Court of Appeals for the District of Columbia or for the circuit in which his principal place of business is located upon petition filed with the court and delivered to the Attorney General within thirty days after notice of the decision. Findings of fact by the Attorney General, if supported by substantial evidence, shall be conclusive. # §878. Powers of enforcement personnel - (a) Any officer or employee of the [Drug Enforcement Administration](/usc/21/802.md?p=4) or any [State](/usc/21/802.md?p=26), tribal, or local law enforcement officer designated by the Attorney General may— - (1) carry firearms; - (2) execute and serve search warrants, arrest warrants, administrative inspection warrants, subpenas, and summonses issued under the authority of the [United States](/usc/21/802.md?p=28); - (3) make arrests without warrant (A) for any offense against the [United States](/usc/21/802.md?p=28) committed in his presence, or (B) for any [felony](/usc/21/802.md?p=13), cognizable under the laws of the [United States](/usc/21/802.md?p=28), if he has probable cause to believe that the [person](/usc/21/379j–21.md?p=k-10) to be arrested has committed or is committing a [felony](/usc/21/802.md?p=13); - (4) make seizures of property pursuant to the provisions of this subchapter; and - (5) perform such other law enforcement duties as the Attorney General may designate. - (b) [State](/usc/21/802.md?p=26) and local law enforcement officers performing functions under this section shall not be deemed Federal employees and shall not be subject to provisions of law relating to Federal employees, except that such officers shall be subject to [section 3374(c) of title 5](/usc/5/3374.md?p=c). # §879. Search warrants A search warrant relating to offenses involving [controlled substances](/usc/21/802.md?p=6) may be served at any time of the day or night if the judge or [United States](/usc/21/802.md?p=28) magistrate judge issuing the warrant is satisfied that there is probable cause to believe that grounds exist for the warrant and for its service at such time. # §880. Administrative inspections and warrants - (a) **“Controlled premises” defined—** As used in this section, the term “controlled premises” means— - (1) places where original or other records or documents required under this subchapter are kept or required to be kept, and - (2) places, including factories, warehouses, and other establishments, and conveyances, where [persons](/usc/21/379j–21.md?p=k-10) registered under [section 823 of this title](/usc/21/823.md) (or exempt from registration under [section 822(d) of this title](/usc/21/822.md?p=d) or by regulation of the Attorney General) or [regulated persons](/usc/21/802.md?p=38) may lawfully hold, [manufacture](/usc/21/802.md?p=15), [distribute](/usc/21/802.md?p=11), [dispense](/usc/21/802.md?p=10), [administer](/usc/21/802.md?p=2), or otherwise dispose of [controlled substances](/usc/21/802.md?p=6) or [listed chemicals](/usc/21/802.md?p=33) or where records relating to those activities are maintained. - (b) **Grant of authority; scope of inspections—** - (1) For the purpose of inspecting, copying, and verifying the correctness of records, reports, or other documents required to be kept or made under this subchapter and otherwise facilitating the carrying out of his functions under this subchapter, the Attorney General is [authorized](/usc/21/360eee–1.md?p=a-6), in accordance with this section, to enter [controlled premises](#a) and to conduct administrative inspections thereof, and of the things specified in this section, relevant to those functions. - (2) Such entries and inspections shall be carried out through officers or employees (hereinafter referred to as “inspectors”) designated by the Attorney General. Any such inspector, upon stating his purpose and presenting to the owner, operator, or [agent](/usc/21/802.md?p=3) in charge of such premises (A) appropriate credentials and (B) a written notice of his inspection authority (which notice in the case of an inspection requiring, or in fact supported by, an administrative inspection warrant shall consist of such warrant), shall have the right to enter such premises and conduct such inspection at reasonable times. - (3) Except as may otherwise be indicated in an applicable inspection warrant, the inspector shall have the right— - (A) to inspect and copy records, reports, and other documents required to be kept or made under this subchapter; - (B) to inspect, within reasonable limits and in a reasonable manner, [controlled premises](#a) and all pertinent equipment, finished and unfinished [drugs](/usc/21/321.md?p=g-1), [listed chemicals](/usc/21/802.md?p=33), and other substances or materials, containers, and labeling found therein, and, except as provided in paragraph (4) of this subsection, all other things therein (including records, files, papers, processes, [controls](/usc/21/802.md?p=5), and [facilities](/usc/21/350g.md?p=o-2)) appropriate for [verification](/usc/21/360eee.md?p=28) of the records, reports, and documents referred to in [clause (A)](#b-3-A) or otherwise bearing on the provisions of this subchapter; and - (C) to inventory any stock of any [controlled substance](/usc/21/802.md?p=6) or [listed chemical](/usc/21/802.md?p=33) therein and obtain samples of any such substance or chemical. - (4) Except when the owner, operator, or [agent](/usc/21/802.md?p=3) in charge of the [controlled premises](#a) so consents in writing, no inspection [authorized](/usc/21/360eee–1.md?p=a-6) by this section shall extend to— - (A) financial data; - (B) sales data other than shipment data; or - (C) pricing data. - (c) **Situations not requiring warrants—** A warrant under this section shall not be required for the inspection of books and records pursuant to an administrative subpena issued in accordance with [section 876 of this title](/usc/21/876.md), nor for entries and administrative inspections (including seizures of property)— - (1) with the consent of the owner, operator, or [agent](/usc/21/802.md?p=3) in charge of the [controlled premises](#a); - (2) in situations presenting imminent danger to health or safety; - (3) in situations involving inspection of conveyances where there is reasonable cause to believe that the mobility of the conveyance makes it impracticable to obtain a warrant; - (4) in any other exceptional or emergency circumstance where time or opportunity to apply for a warrant is lacking; or - (5) in any other situations where a warrant is not constitutionally required. - (d) **Administrative inspection warrants; issuance; execution; probable cause—** Issuance and execution of administrative inspection warrants shall be as follows: - (1) Any judge of the [United States](/usc/21/802.md?p=28) or of a [State](/usc/21/802.md?p=26) court of record, or any [United States](/usc/21/802.md?p=28) magistrate judge, may, within his territorial jurisdiction, and upon proper oath or affirmation showing probable cause, issue warrants for the purpose of conducting administrative inspections [authorized](/usc/21/360eee–1.md?p=a-6) by this subchapter or regulations thereunder, and seizures of property appropriate to such inspections. For the purposes of this section, the term “probable cause” means a valid public interest in the effective enforcement of this subchapter or regulations thereunder sufficient to justify administrative inspections of the area, premises, building, or conveyance, or contents thereof, in the circumstances specified in the application for the warrant. - (2) A warrant shall issue only upon an affidavit of an officer or employee having knowledge of the facts alleged, sworn to before the judge or magistrate judge and establishing the grounds for issuing the warrant. If the judge or magistrate judge is satisfied that grounds for the application exist or that there is [probable cause](#d-1) to believe they exist, he shall issue a warrant identifying the area, premises, building, or conveyance to be inspected, the purpose of such inspection, and, where appropriate, the type of property to be inspected, if any. The warrant shall identify the items or types of property to be seized, if any. The warrant shall be directed to a [person](/usc/21/379j–21.md?p=k-10) [authorized](/usc/21/360eee–1.md?p=a-6) under [subsection (b)(2)](#b-2) to execute it. The warrant shall [state](/usc/21/802.md?p=26) the grounds for its issuance and the name of the [person](/usc/21/379j–21.md?p=k-10) or [persons](/usc/21/379j–21.md?p=k-10) whose affidavit has been taken in support thereof. It shall command the [person](/usc/21/379j–21.md?p=k-10) to whom it is directed to inspect the area, premises, building, or conveyance identified for the purpose specified, and, where appropriate, shall direct the seizure of the property specified. The warrant shall direct that it be served during normal business hours. It shall designate the judge or magistrate judge to whom it shall be returned. - (3) A warrant issued pursuant to this section must be executed and returned within ten days of its date unless, upon a showing by the [United States](/usc/21/802.md?p=28) of a need therefor, the judge or magistrate judge allows additional time in the warrant. If property is seized pursuant to a warrant, the [person](/usc/21/379j–21.md?p=k-10) executing the warrant shall give to the [person](/usc/21/379j–21.md?p=k-10) from whom or from whose premises the property was taken a copy of the warrant and a receipt for the property taken or shall leave the copy and receipt at the place from which the property was taken. The return of the warrant shall be made promptly and shall be accompanied by a written inventory of any property taken. The inventory shall be made in the presence of the [person](/usc/21/379j–21.md?p=k-10) executing the warrant and of the [person](/usc/21/379j–21.md?p=k-10) from whose possession or premises the property was taken, if they are present, or in the presence of at least one credible [person](/usc/21/379j–21.md?p=k-10) other than the [person](/usc/21/379j–21.md?p=k-10) making such inventory, and shall be verified by the [person](/usc/21/379j–21.md?p=k-10) executing the warrant. The judge or magistrate judge, upon request, shall [deliver](/usc/21/802.md?p=8) a copy of the inventory to the [person](/usc/21/379j–21.md?p=k-10) from whom or from whose premises the property was taken and to the applicant for the warrant. - (4) The judge or magistrate judge who has issued a warrant under this section shall attach to the warrant a copy of the return and all papers filed in connection therewith and shall file them with the clerk of the district court of the [United States](/usc/21/802.md?p=28) for the judicial district in which the inspection was made. # §881. Forfeitures - (a) **Subject property—** The following shall be subject to forfeiture to the [United States](/usc/21/802.md?p=28) and no property right shall exist in them: - (1) All [controlled substances](/usc/21/802.md?p=6) which have been manufactured, distributed, dispensed, or acquired in violation of this subchapter. - (2) All raw materials, products, and equipment of any kind which are used, or intended for use, in manufacturing, compounding, processing, delivering, importing, or exporting any [controlled substance](/usc/21/802.md?p=6) or [listed chemical](/usc/21/802.md?p=33) in violation of this subchapter. - (3) All property which is used, or intended for use, as a container for property described in paragraph [(1)](#a-1), [(2)](#a-2), or [(9)](#a-9). - (4) All conveyances, including aircraft, vehicles, or vessels, which are used, or are intended for use, to transport, or in any manner to facilitate the transportation, sale, receipt, possession, or concealment of property described in paragraph [(1)](#a-1), [(2)](#a-2), or [(9)](#a-9). - (5) All books, records, and research, including formulas, microfilm, tapes, and data which are used, or intended for use, in violation of this subchapter. - (6) All moneys, negotiable instruments, securities, or other things of value furnished or intended to be furnished by any [person](/usc/21/379j–21.md?p=k-10) in exchange for a [controlled substance](/usc/21/802.md?p=6) or [listed chemical](/usc/21/802.md?p=33) in violation of this subchapter, all proceeds traceable to such an exchange, and all moneys, negotiable instruments, and securities used or intended to be used to facilitate any violation of this subchapter. - (7) All real property, including any right, title, and interest (including any leasehold interest) in the whole of any lot or tract of land and any appurtenances or improvements, which is used, or intended to be used, in any manner or part, to commit, or to facilitate the commission of, a violation of this subchapter punishable by more than one year’s imprisonment. - (8) All [controlled substances](/usc/21/802.md?p=6) which have been possessed in violation of this subchapter. - (9) All [listed chemicals](/usc/21/802.md?p=33), all [drug](/usc/21/321.md?p=g-1) manufacturing equipment, all tableting machines, all encapsulating machines, and all gelatin capsules, which have been imported, exported, manufactured, possessed, distributed, dispensed, acquired, or intended to be distributed, dispensed, acquired, imported, or exported, in violation of this subchapter or subchapter II. - (10) Any [drug paraphernalia](/usc/21/863.md?p=d) (as defined in [section 863 of this title](/usc/21/863.md)). - (11) Any firearm (as defined in [section 921 of title 18](/usc/18/921.md)) used or intended to be used to facilitate the transportation, sale, receipt, possession, or concealment of property described in paragraph [(1)](#a-1) or [(2)](#a-2) and any proceeds traceable to such property. - (b) **Seizure procedures—** Any property subject to forfeiture to the [United States](/usc/21/802.md?p=28) under this section may be seized by the Attorney General in the manner set forth in [section 981(b) of title 18](/usc/18/981.md?p=b). - (c) **Custody of Attorney General—** Property taken or detained under this section shall not be repleviable, but shall be deemed to be in the custody of the Attorney General, subject only to the orders and decrees of the court or the official having jurisdiction thereof. Whenever property is seized under any of the provisions of this subchapter, the Attorney General may— - (1) place the property under seal; - (2) remove the property to a place designated by him; or - (3) require that the General Services Administration take custody of the property and remove it, if practicable, to an appropriate location for disposition in accordance with law. - (d) **Other laws and proceedings applicable—** The provisions of law relating to the seizure, summary and judicial forfeiture, and condemnation of property for violation of the customs laws; the disposition of such property or the proceeds from the sale thereof; the remission or mitigation of such forfeitures; and the compromise of claims shall apply to seizures and forfeitures incurred, or alleged to have been incurred, under any of the provisions of this subchapter, insofar as applicable and not inconsistent with the provisions hereof; except that such duties as are imposed upon the customs officer or any other [person](/usc/21/379j–21.md?p=k-10) with respect to the seizure and forfeiture of property under the customs laws shall be performed with respect to seizures and forfeitures of property under this subchapter by such officers, [agents](/usc/21/802.md?p=3), or other [persons](/usc/21/379j–21.md?p=k-10) as may be [authorized](/usc/21/360eee–1.md?p=a-6) or designated for that purpose by the Attorney General, except to the extent that such duties arise from seizures and forfeitures effected by any customs officer. - (e) **Disposition of forfeited property—** - (1) Whenever property is civilly or criminally forfeited under this subchapter the Attorney General may— - (A) retain the property for official use or, in the manner provided with respect to transfers under [section 1616a of title 19](/usc/19/1616a.md), transfer the property to any Federal agency or to any [State](/usc/21/802.md?p=26) or local law enforcement agency which participated directly in the seizure or forfeiture of the property; - (B) except as provided in [paragraph (4)](#e-4), sell, by public sale or any other commercially feasible means, any forfeited property which is not required to be destroyed by law and which is not harmful to the public; - (C) require that the General Services Administration take custody of the property and dispose of it in accordance with law; - (D) forward it to the Bureau of Narcotics and Dangerous [Drugs](/usc/21/321.md?p=g-1) for disposition (including [delivery](/usc/21/802.md?p=8) for medical or scientific use to any Federal or [State](/usc/21/802.md?p=26) agency under regulations of the Attorney General); or - (E) transfer the forfeited personal property or the proceeds of the sale of any forfeited personal or real property to any foreign country which participated directly or indirectly in the seizure or forfeiture of the property, if such a transfer— - (i) has been agreed to by the Secretary of State; - (ii) is [authorized](/usc/21/360eee–1.md?p=a-6) in an international agreement between the [United States](/usc/21/802.md?p=28) and the foreign country; and - (iii) is made to a country which, if applicable, has been certified under [section 2291j(b) of title 22](/usc/22/2291j.md?p=b). - (2) - (A) The proceeds from any sale under [subparagraph (B)](#e-1-B) of paragraph (1) and any moneys forfeited under this subchapter shall be used to pay— - (i) all property expenses of the proceedings for forfeiture and sale including expenses of seizure, maintenance of custody, advertising, and court costs; and - (ii) awards of up to $100,000 to any individual who provides original information which leads to the arrest and conviction of a [person](/usc/21/379j–21.md?p=k-10) who kills or kidnaps a Federal [drug](/usc/21/321.md?p=g-1) law enforcement [agent](/usc/21/802.md?p=3). Any award paid for information concerning the killing or kidnapping of a Federal [drug](/usc/21/321.md?p=g-1) law enforcement [agent](/usc/21/802.md?p=3), as provided in [clause (ii)](#e-2-A-ii), shall be paid at the discretion of the Attorney General. - (B) The Attorney General shall forward to the Treasurer of the [United States](/usc/21/802.md?p=28) for deposit in accordance with [section 524(c) of title 28](/usc/28/524.md?p=c), any amounts of such moneys and proceeds remaining after payment of the expenses provided in [subparagraph (A)](#e-2-A), except that, with respect to forfeitures conducted by the Postal Service, the Postal Service shall deposit in the Postal Service Fund, under [section 2003(b)(7) of title 39](/usc/39/2003.md?p=b-7), such moneys and proceeds. - (3) The Attorney General shall assure that any property transferred to a [State](/usc/21/802.md?p=26) or local law enforcement agency under [paragraph (1)(A)](#e-1-A)— - (A) has a value that bears a reasonable relationship to the degree of direct participation of the [State](/usc/21/802.md?p=26) or local agency in the law enforcement effort resulting in the forfeiture, taking into account the total value of all property forfeited and the total law enforcement effort with respect to the violation of law on which the forfeiture is based; and - (B) will serve to encourage further cooperation between the recipient [State](/usc/21/802.md?p=26) or local agency and Federal law enforcement agencies. - (4) - (A) With respect to real property described in [subparagraph (B)](#e-4-B), if the chief executive officer of the [State](/usc/21/802.md?p=26) involved submits to the Attorney General a request for purposes of such subparagraph, the authority established in such subparagraph is in lieu of the authority established in [paragraph (1)(B)](#e-1-B). - (B) In the case of property described in [paragraph (1)(B)](#e-1-B) that is civilly or criminally forfeited under this subchapter, if the property is real property that is appropriate for use as a public area reserved for recreational or historic purposes or for the preservation of natural conditions, the Attorney General, upon the request of the chief executive officer of the [State](/usc/21/802.md?p=26) in which the property is located, may transfer title to the property to the [State](/usc/21/802.md?p=26), either without charge or for a nominal charge, through a legal instrument providing that— - (i) such use will be the principal use of the property; and - (ii) title to the property reverts to the [United States](/usc/21/802.md?p=28) in the event that the property is used otherwise. - (f) **Forfeiture and destruction of schedule I and II substances—** - (1) All [controlled substances](/usc/21/802.md?p=6) in schedule I or II that are possessed, transferred, sold, or offered for sale in violation of the provisions of this subchapter; all dangerous, toxic, or hazardous raw materials or products subject to forfeiture under [subsection (a)(2)](#a-2) of this section; and any equipment or container subject to forfeiture under subsection [(a)(2)](#a-2) or [(3)](#a-3) which cannot be separated safely from such raw materials or products shall be deemed contraband and seized and summarily forfeited to the [United States](/usc/21/802.md?p=28). Similarly, all substances in schedule I or II, which are seized or come into the possession of the [United States](/usc/21/802.md?p=28), the owners of which are unknown, shall be deemed contraband and summarily forfeited to the [United States](/usc/21/802.md?p=28). - (2) The Attorney General may direct the destruction of all [controlled substances](/usc/21/802.md?p=6) in schedule I or II seized for violation of this subchapter; all dangerous, toxic, or hazardous raw materials or products subject to forfeiture under [subsection (a)(2)](#a-2) of this section; and any equipment or container subject to forfeiture under subsection [(a)(2)](#a-2) or [(3)](#a-3) which cannot be separated safely from such raw materials or products under such circumstances as the Attorney General may deem necessary. - (g) **Plants—** - (1) All species of plants from which [controlled substances](/usc/21/802.md?p=6) in schedules I and II may be derived which have been planted or cultivated in violation of this subchapter, or of which the owners or cultivators are unknown, or which are wild growths, may be seized and summarily forfeited to the [United States](/usc/21/802.md?p=28). - (2) The failure, upon demand by the Attorney General or his duly [authorized](/usc/21/360eee–1.md?p=a-6) [agent](/usc/21/802.md?p=3), of the [person](/usc/21/379j–21.md?p=k-10) in occupancy or in [control](/usc/21/802.md?p=5) of land or premises upon which such species of plants are growing or being stored, to produce an appropriate registration, or proof that he is the holder thereof, shall constitute authority for the seizure and forfeiture. - (3) The Attorney General, or his duly [authorized](/usc/21/360eee–1.md?p=a-6) [agent](/usc/21/802.md?p=3), shall have authority to enter upon any lands, or into any dwelling pursuant to a search warrant, to cut, harvest, carry off, or destroy such plants. - (h) **Vesting of title in United States—** All right, title, and interest in property described in [subsection (a)](#a) shall vest in the [United States](/usc/21/802.md?p=28) upon commission of the act giving rise to forfeiture under this section. - (i) **Stay of civil forfeiture proceedings—** The provisions of [section 981(g) of title 18](/usc/18/981.md?p=g) regarding the stay of a civil forfeiture proceeding shall apply to forfeitures under this section. - (j) **Venue—** In addition to the venue provided for in [section 1395 of title 28](/usc/28/1395.md) or any other provision of law, in the case of property of a defendant charged with a violation that is the basis for forfeiture of the property under this section, a proceeding for forfeiture under this section may be brought in the judicial district in which the defendant owning such property is found or in the judicial district in which the criminal prosecution is brought. - (l) **[^1] Agreement between Attorney General and Postal Service for performance of functions—** The functions of the Attorney General under this section shall be carried out by the Postal Service pursuant to such agreement as may be entered into between the Attorney General and the Postal Service. # [§881–1. Transferred — transferred] # [§881a. Transferred — transferred] # §882. Injunctions - (a) **Jurisdiction—** The district courts of the [United States](/usc/21/802.md?p=28) and all courts exercising general jurisdiction in the [territories](/usc/21/387.md?p=19) and possessions of the [United States](/usc/21/802.md?p=28) shall have jurisdiction in proceedings in accordance with the Federal Rules of Civil Procedure to enjoin violations of this subchapter. - (b) **Jury trial—** In case of an alleged violation of an injunction or restraining order issued under this section, trial shall, upon demand of the accused, be by a jury in accordance with the Federal Rules of Civil Procedure. - (c) **State cause of action pertaining to online pharmacies—** - (1) **In general—** In any case in which the [State](/usc/21/802.md?p=26) has reason to believe that an interest of the residents of that [State](/usc/21/802.md?p=26) has been or is being threatened or adversely affected by the action of a [person](/usc/21/379j–21.md?p=k-10), entity, or [Internet](/usc/21/802.md?p=50) site that violates the provisions of section [823(g)](/usc/21/823.md?p=g), [829(e)](/usc/21/829.md?p=e), or [831](/usc/21/831.md) of this title, the [State](/usc/21/802.md?p=26) may bring a civil action on behalf of such residents in a district court of the [United States](/usc/21/802.md?p=28) with appropriate jurisdiction— - (A) to enjoin the conduct which violates this section; - (B) to enforce compliance with this section; - (C) to obtain damages, restitution, or other compensation, including civil penalties under [section 842(b) of this title](/usc/21/842.md?p=b); and - (D) to obtain such other legal or equitable relief as the court may find appropriate. - (2) **Service; intervention—** - (A) Prior to filing a complaint under [paragraph (1)](#c-1), the [State](/usc/21/802.md?p=26) shall serve a copy of the complaint upon the Attorney General and upon the [United States](/usc/21/802.md?p=28) Attorney for the judicial district in which the complaint is to be filed. In any case where such prior service is not feasible, the [State](/usc/21/802.md?p=26) shall serve the complaint on the Attorney General and the appropriate [United States](/usc/21/802.md?p=28) Attorney on the same day that the [State](/usc/21/802.md?p=26)’s complaint is filed in Federal district court of the [United States](/usc/21/802.md?p=28). Such proceedings shall be independent of, and not in lieu of, criminal prosecutions or any other proceedings under this subchapter or any other laws of the [United States](/usc/21/802.md?p=28). - (B) Upon receiving notice respecting a civil action pursuant to this section, the [United States](/usc/21/802.md?p=28) shall have the right to intervene in such action and, upon so intervening, to be heard on all matters arising therein, and to file petitions for appeal. - (C) Service of a [State](/usc/21/802.md?p=26)’s complaint on the [United States](/usc/21/802.md?p=28) as required in this paragraph shall be made in accord with the requirements of rule 4(i)(1) of the Federal Rule[^1] of Civil Procedure. - (3) **Powers conferred by State law—** For purposes of bringing any civil action under [paragraph (1)](#c-1), nothing in this chapter shall prevent an attorney general of a [State](/usc/21/802.md?p=26) from exercising the powers conferred on the attorney general of a [State](/usc/21/802.md?p=26) by the laws of such [State](/usc/21/802.md?p=26) to conduct investigations or to [administer](/usc/21/802.md?p=2) oaths or affirmations or to compel the attendance of witnesses of or the [production](/usc/21/802.md?p=22) of documentary or other evidence. - (4) **Venue—** Any civil action brought under [paragraph (1)](#c-1) in a district court of the [United States](/usc/21/802.md?p=28) may be brought in the district in which the defendant is found, is an inhabitant, or transacts business or wherever venue is proper under [section 1391 of title 28](/usc/28/1391.md). Process in such action may be served in any district in which the defendant is an inhabitant or in which the defendant may be found. - (5) **No private right of action—** No private right of action is created under this subsection. - (6) **Limitation—** No civil action may be brought under [paragraph (1)](#c-1) against— - (A) the [United States](/usc/21/802.md?p=28); - (B) an Indian Tribe or tribal organization, to the extent such tribe or tribal organization is lawfully carrying out a contract or compact under the Indian Self-Determination and Education Assistance Act [[25 U.S.C. 5301](/usc/25/5301.md) et seq.]; or - (C) any employee of the [United States](/usc/21/802.md?p=28) or such Indian tribe or tribal organization, provided such [agent](/usc/21/802.md?p=3) or employee is acting in the usual course of business or employment, and within the scope of the official duties of such [agent](/usc/21/802.md?p=3) or employee therewith. # §883. Enforcement proceedings Before any violation of this subchapter is reported by the [Administrator](/usc/21/1523.md?p=1) of the [Drug Enforcement Administration](/usc/21/802.md?p=4) to any [United States](/usc/21/802.md?p=28) attorney for institution of a criminal proceeding, the [Administrator](/usc/21/1523.md?p=1) may require that the [person](/usc/21/379j–21.md?p=k-10) against whom such proceeding is contemplated is given appropriate notice and an opportunity to present his views, either orally or in writing, with regard to such contemplated proceeding. # §884. Immunity and privilege - (a) **Refusal to testify—** Whenever a witness refuses, on the basis of his privilege against self-incrimination, to testify or provide other information in a proceeding before a court or grand jury of the [United States](/usc/21/802.md?p=28), involving a violation of this subchapter, and the [person](/usc/21/379j–21.md?p=k-10) presiding over the proceeding communicates to the witness an order issued under this section, the witness may not refuse to comply with the order on the basis of his privilege against self-incrimination. But no testimony or other information compelled under the order issued under [subsection (b)](#b) of this section or any information obtained by the exploitation of such testimony or other information, may be used against the witness in any criminal case, including any criminal case brought in a court of a [State](/usc/21/802.md?p=26), except a prosecution for perjury, giving a false statement, or otherwise failing to comply with the order. - (b) **Order of United States district court—** In the case of any individual who has been or may be called to testify or provide other information at any proceeding before a court or grand jury of the [United States](/usc/21/802.md?p=28), the [United States](/usc/21/802.md?p=28) district court for the judicial district in which the proceeding is or may be held shall issue, upon the request of the [United States](/usc/21/802.md?p=28) attorney for such district, an order requiring such individual to give any testimony or provide any other information which he refuses to give or provide on the basis of his privilege against self-incrimination. - (c) **Request by United States attorney—** A [United States](/usc/21/802.md?p=28) attorney may, with the approval of the Attorney General or the Deputy Attorney General, the Associate Attorney General, or any Assistant Attorney General designated by the Attorney General, request an order under [subsection (b)](#b) when in his judgment— - (1) the testimony or other information from such individual may be necessary to the public interest; and - (2) such individual has refused or is likely to refuse to testify or provide other information on the basis of his privilege against self-incrimination. # §885. Burden of proof; liabilities - (a) **Exemptions and exceptions; presumption in simple possession offenses—** - (1) It shall not be necessary for the [United States](/usc/21/802.md?p=28) to negative any exemption or exception set forth in this subchapter in any complaint, information, indictment, or other pleading or in any trial, hearing, or other proceeding under this subchapter, and the burden of going forward with the evidence with respect to any such exemption or exception shall be upon the [person](/usc/21/379j–21.md?p=k-10) claiming its benefit. - (2) In the case of a [person](/usc/21/379j–21.md?p=k-10) charged under [section 844(a) of this title](/usc/21/844.md?p=a) with the possession of a [controlled substance](/usc/21/802.md?p=6), any label identifying such substance for purposes of [section 353(b)(2) of this title](/usc/21/353.md?p=b-2) shall be admissible in evidence and shall be prima facie evidence that such substance was obtained pursuant to a valid prescription from a [practitioner](/usc/21/802.md?p=21) while acting in the course of his professional practice. - (b) **Registration and order forms—** In the absence of proof that a [person](/usc/21/379j–21.md?p=k-10) is the duly [authorized](/usc/21/360eee–1.md?p=a-6) holder of an appropriate registration or order form issued under this subchapter, he shall be presumed not to be the holder of such registration or form, and the burden of going forward with the evidence with respect to such registration or form shall be upon him. - (c) **Use of vehicles, vessels, and aircraft—** The burden of going forward with the evidence to establish that a vehicle, vessel, or aircraft used in connection with [controlled substances](/usc/21/802.md?p=6) in schedule I was used in accordance with the provisions of this subchapter shall be on the [persons](/usc/21/379j–21.md?p=k-10) engaged in such use. - (d) **Immunity of Federal, State, local and other officials—** Except as provided in sections [2234](/usc/18/2234.md) and [2235](/usc/18/2235.md) of title 18, no civil or criminal liability shall be imposed by virtue of this subchapter upon any duly [authorized](/usc/21/360eee–1.md?p=a-6) Federal officer lawfully engaged in the enforcement of this subchapter, or upon any duly [authorized](/usc/21/360eee–1.md?p=a-6) officer of any [State](/usc/21/802.md?p=26), [territory](/usc/21/387.md?p=19), political subdivision thereof, the District of Columbia, or any possession of the [United States](/usc/21/802.md?p=28), who shall be lawfully engaged in the enforcement of any law or municipal ordinance relating to [controlled substances](/usc/21/802.md?p=6). # §886. Payments and advances - (a) **Payment to informers—** The Attorney General is [authorized](/usc/21/360eee–1.md?p=a-6) to pay any [person](/usc/21/379j–21.md?p=k-10), from funds appropriated for the [Drug Enforcement Administration](/usc/21/802.md?p=4), for information concerning a violation of this subchapter, such sum or sums of money as he may deem appropriate, without reference to any moieties or rewards to which such [person](/usc/21/379j–21.md?p=k-10) may otherwise be entitled by law. - (b) **Reimbursement for purchase of controlled substances—** Moneys expended from appropriations of the [Drug Enforcement Administration](/usc/21/802.md?p=4) for purchase of [controlled substances](/usc/21/802.md?p=6) and subsequently recovered shall be reimbursed to the current appropriation for the Administration.[^1] - (c) **Advance of funds for enforcement purposes—** The Attorney General is [authorized](/usc/21/360eee–1.md?p=a-6) to direct the advance of funds by the Treasury Department in connection with the enforcement of this subchapter. - (d) **Drug Pollution Fund—** - (1) There is established in the Treasury a trust fund to be known as the “[Drug](/usc/21/321.md?p=g-1) Pollution Fund” (hereinafter referred to in this subsection as the “Fund”), consisting of amounts appropriated or credited to such Fund under [section 841(b)(6) of this title](/usc/21/841.md?p=b-6). - (2) There are hereby appropriated to the Fund amounts equivalent to the fines imposed under [section 841(b)(6) of this title](/usc/21/841.md?p=b-6). - (3) Amounts in the Fund shall be available, as provided in appropriations Acts, for the purpose of making payments in accordance with [paragraph (4)](#d-4) for the clean up of certain pollution resulting from the actions referred to in [section 841(b)(6) of this title](/usc/21/841.md?p=b-6). - (4) - (A) The [Secretary](/usc/21/802.md?p=24) of the Treasury, after consultation with the Attorney General, shall make payments under [paragraph (3)](#d-3), in such amounts as the [Secretary](/usc/21/802.md?p=24) determines appropriate, to the heads of executive agencies or departments that meet the requirements of [subparagraph (B)](#d-4-B). - (B) In order to receive a payment under [paragraph (3)](#d-3), the head of an executive agency or department shall submit an application in such form and containing such information as the [Secretary](/usc/21/802.md?p=24) of the Treasury shall by regulation require. Such application shall contain a description of the fine imposed under [section 841(b)(6) of this title](/usc/21/841.md?p=b-6), the circumstances surrounding the imposition of such fine, and the type and severity of pollution that resulted from the actions to which such fine applies. - (5) For purposes of subchapter B of [chapter 98](/usc/26/chstI-ch98.md) of title 26, the Fund established under this paragraph shall be treated in the same manner as a trust fund established under subchapter A of such chapter. # §886a. Diversion Control Fee Account - (1) **In general—** There is established in the general fund of the Treasury a separate account which shall be known as the Diversion [Control](/usc/21/802.md?p=5) Fee Account. For fiscal year 1993 and thereafter: - (A) There shall be deposited as offsetting receipts into that account all fees collected by the [Drug Enforcement Administration](/usc/21/802.md?p=4), in excess of $15,000,000, for the operation of its [diversion control program](#2-A). - (B) Such amounts as are deposited into the Diversion [Control](/usc/21/802.md?p=5) Fee Account shall remain available until expended and shall be refunded out of that account by the [Secretary](/usc/21/802.md?p=24) of the Treasury, at least on a quarterly basis, to reimburse the [Drug Enforcement Administration](/usc/21/802.md?p=4) for expenses incurred in the operation of the [diversion control program](#2-A). Such reimbursements shall be made without distinguishing between expenses related to [controlled substance](/usc/21/802.md?p=6) activities and expenses related to chemical activities. - (C) Fees charged by the [Drug Enforcement Administration](/usc/21/802.md?p=4) under its [diversion control program](#2-A) shall be set at a level that ensures the recovery of the full costs of operating the various aspects of that [program](/usc/21/1523.md?p=8). - (D) The amount required to be refunded from the Diversion [Control](/usc/21/802.md?p=5) Fee Account for fiscal year 1994 and thereafter shall be refunded in accordance with estimates made in the budget request of the Attorney General for those fiscal years. Any proposed changes in the amounts designated in said budget requests shall only be made after notification to the Committees on Appropriations of the House of Representatives and the Senate fifteen days in advance. - (2) **Definitions—** In this section: - (A) **Diversion control program—** The term “diversion control program” means the [controlled substance and chemical diversion control activities](#2-B) of the [Drug Enforcement Administration](/usc/21/802.md?p=4). - (B) **Controlled substance and chemical diversion control activities—** The term “controlled substance and chemical diversion control activities” means those activities related to the registration and [control](/usc/21/802.md?p=5) of the [manufacture](/usc/21/802.md?p=15), [distribution](/usc/21/360eee.md?p=5), dispensing, importation, and exportation of [controlled substances](/usc/21/802.md?p=6) and [listed chemicals](/usc/21/802.md?p=33). # §887. Coordination and consolidation of post-seizure administration The Attorney General and the [Secretary](/usc/21/802.md?p=24) of the Treasury shall take such action as may be necessary to develop and maintain a joint plan to coordinate and consolidate post-seizure administration of property seized under this subchapter, subchapter II, or provisions of the customs laws relating to [controlled substances](/usc/21/802.md?p=6). # [§888. Repealed. Pub. L. 106–185, § 2(c)(3), Apr. 25, 2000, 114 Stat. 210 — repealed] # §889. Production control of controlled substances - (a) **Definitions—** As used in this section: - (1) The term “[controlled substance](/usc/21/802.md?p=6)” has the same meaning given such term in [section 802(6) of this title](/usc/21/802.md?p=6). - (2) The term “Secretary” means the Secretary of Agriculture. - (3) The term “State” means each of the fifty States, the District of Columbia, the Commonwealth of Puerto Rico, Guam, the Virgin Islands of the [United States](/usc/21/802.md?p=28), American Samoa, the Commonwealth of the Northern Mariana Islands, or the Trust [Territory](/usc/21/387.md?p=19) of the Pacific Islands. - (b) **Persons ineligible for Federal agricultural program benefits—** Notwithstanding any other provision of law, following December 23, 1985, any [person](#c-1) who is convicted under Federal or [State](#a-3) law of planting, cultivation, growing, producing, harvesting, or storing a [controlled substance](/usc/21/802.md?p=6) in any crop year shall be ineligible for— - (1) as to any commodity produced during that crop year, and the four succeeding crop years, by such [person](#c-1)— - (A) any price support or payment made available under the Agricultural Act of 1949 ([7 U.S.C. 1421](/usc/7/1421.md) et seq.), the Commodity Credit Corporation Charter Act ([15 U.S.C. 714](/usc/15/714.md) et seq.), or any other Act; - (B) a farm storage [facility](/usc/21/350g.md?p=o-2) loan made under section 4(h) of the Commodity Credit Corporation Charter Act ([15 U.S.C. 714b(h)](/usc/15/714b.md?p=h)); - (C) crop insurance under the Federal Crop Insurance Act ([7 U.S.C. 1501](/usc/7/1501.md) et seq.); - (D) a disaster payment made under the Agricultural Act of 1949 ([7 U.S.C. 1421](/usc/7/1421.md) et seq.); or - (E) a loan made, insured or guaranteed under the Consolidated Farm and Rural Development Act ([7 U.S.C. 1921](/usc/7/1921.md) et seq.) or any other provision of law administered by the Farmers Home Administration; or - (2) a payment made under section 4 or 5 of the Commodity Credit Corporation Charter Act ([15 U.S.C. 714b](/usc/15/714b.md) or 714c) for the storage of an agricultural commodity that is— - (A) produced during that crop year, or any of the four succeeding crop years, by such [person](#c-1); and - (B) acquired by the Commodity Credit Corporation. - (c) **Regulations—** Not later than 180 days after December 23, 1985, the [Secretary](#a-2) shall issue such regulations as the [Secretary](#a-2) determines are necessary to carry out this section, including regulations that— - (1) define the term “person”; - (2) govern the determination of [persons](#c-1) who shall be ineligible for [program](/usc/21/1523.md?p=8) benefits under this section; and - (3) protect the interests of tenants and sharecroppers. # §890. Review of Federal sales of chemicals usable to manufacture controlled substances A Federal department or agency may not sell from the stocks of the department or agency any chemical which, as determined by the [Administrator](/usc/21/1523.md?p=1) of the [Drug Enforcement Administration](/usc/21/802.md?p=4), could be used in the [manufacture](/usc/21/802.md?p=15) of a [controlled substance](/usc/21/802.md?p=6) unless the [Administrator](/usc/21/1523.md?p=1) certifies in writing to the head of the department or agency that there is no reasonable cause to believe that the sale of the chemical would result in the illegal [manufacture](/usc/21/802.md?p=15) of a [controlled substance](/usc/21/802.md?p=6). # §901. Severability If a provision of this chapter is held invalid, all valid provisions that are severable shall remain in effect. If a provision of this chapter is held invalid in one or more of its applications, the provision shall remain in effect in all its valid applications that are severable. # §902. Savings provisions Nothing in this chapter, except this part and, to the extent of any inconsistency, sections [827(e)](/usc/21/827.md?p=e) and [829](/usc/21/829.md) of this title, shall be construed as in any way affecting, modifying, repealing, or superseding the provisions of the Federal [Food](/usc/21/346a.md?p=a-1), [Drug](/usc/21/321.md?p=g-1), and Cosmetic Act [[21 U.S.C. § 301](/usc/21/301.md) et seq.]. # §903. Application of State law No provision of this subchapter shall be construed as indicating an intent on the part of the Congress to occupy the field in which that provision operates, including criminal penalties, to the exclusion of any [State](/usc/21/802.md?p=26) law on the same subject matter which would otherwise be within the authority of the [State](/usc/21/802.md?p=26), unless there is a positive conflict between that provision of this subchapter and that [State](/usc/21/802.md?p=26) law so that the two cannot consistently stand together. # §904. Payment of tort claims Notwithstanding [section 2680(k) of title 28](/usc/28/2680.md?p=k), the Attorney General, in carrying out the functions of the Department of Justice under this subchapter, is [authorized](/usc/21/360eee–1.md?p=a-6) to pay tort claims in the manner [authorized](/usc/21/360eee–1.md?p=a-6) by [section 2672 of title 28](/usc/28/2672.md), when such claims arise in a foreign country in connection with the operations of the [Drug Enforcement Administration](/usc/21/802.md?p=4) abroad. # §951. Definitions - (a) For purposes of this subchapter— - (1) The term “import” means, with respect to any article, any bringing in or introduction of such article into any area (whether or not such bringing in or introduction constitutes an importation within the meaning of the tariff laws of the United States). - (2) The term “customs territory of the United States” has the meaning assigned to such term by general note 2 of the Harmonized Tariff Schedule of the United States. - (b) Each term defined in [section 802 of this title](/usc/21/802.md) shall have the same meaning for purposes of this subchapter as such term has for purposes of subchapter I. # §952. Importation of controlled substances - (a) **Controlled substances in schedule I or II and narcotic drugs in schedule III, IV, or V; exceptions—** It shall be unlawful to [import](/usc/21/951.md?p=a-1) into the [customs territory of the United States](/usc/21/951.md?p=a-2) from any place outside thereof (but within the United States), or to [import](/usc/21/951.md?p=a-1) into the United States from any place outside thereof, any [controlled substance](/usc/21/889.md?p=a-1) in schedule I or II of subchapter I, or any [narcotic drug](/usc/21/1907.md?p=4) in schedule III, IV, or V of subchapter I, or ephedrine, pseudoephedrine, or phenylpropanolamine, except that— - (1) such amounts of crude opium, poppy straw, concentrate of poppy straw, and coca leaves, and of ephedrine, pseudoephedrine, and phenylpropanolamine, as the Attorney General finds to be necessary to provide for medical, scientific, or other legitimate purposes, and - (2) such amounts of any [controlled substance](/usc/21/889.md?p=a-1) in schedule I or II or any [narcotic drug](/usc/21/1907.md?p=4) in schedule III, IV, or V that the Attorney General finds to be necessary to provide for the medical, scientific, or other legitimate needs of the United States— - (A) during an emergency in which domestic supplies of such substance or [drug](/usc/21/321.md?p=g-1) are found by the Attorney General to be inadequate, - (B) in any case in which the Attorney General finds that competition among domestic manufacturers of the [controlled substance](/usc/21/889.md?p=a-1) is inadequate and will not be rendered adequate by the registration of additional manufacturers under [section 823 of this title](/usc/21/823.md), or - (C) in any case in which the Attorney General finds that such [controlled substance](/usc/21/889.md?p=a-1) is in limited quantities exclusively for scientific, analytical, or research uses, may be so imported under such regulations as the Attorney General shall prescribe. No crude opium may be so imported for the purpose of manufacturing heroin or smoking opium. - (b) **Nonnarcotic controlled substances in schedule III, IV, or V—** It shall be unlawful to [import](/usc/21/951.md?p=a-1) into the [customs territory of the United States](/usc/21/951.md?p=a-2) from any place outside thereof (but within the United States), or to [import](/usc/21/951.md?p=a-1) into the United States from any place outside thereof, any non­narcotic [controlled substance](/usc/21/889.md?p=a-1) in schedule III, IV, or V, unless such nonnarcotic [controlled substance](/usc/21/889.md?p=a-1)— - (1) is imported for medical, scientific, or other legitimate uses, and - (2) is imported pursuant to such notification, or declaration, or in the case of any nonnarcotic [controlled substance](/usc/21/889.md?p=a-1) in schedule III, such [import](/usc/21/951.md?p=a-1) permit, notification, or declaration, as the Attorney General may by regulation prescribe, except that if a nonnarcotic [controlled substance](/usc/21/889.md?p=a-1) in schedule IV or V is also listed in schedule I or II of the Convention on Psychotropic Substances it shall be imported pursuant to such [import](/usc/21/951.md?p=a-1) permit requirements, prescribed by regulation of the Attorney General, as are required by the Convention. - (c) **Coca leaves—** In addition to the amount of coca leaves [authorized](/usc/21/360eee–1.md?p=a-6) to be imported into the United States under [subsection (a)](#a), the Attorney General may permit the importation of additional amounts of coca leaves. All cocaine and ecgonine (and all salts, derivatives, and preparations from which cocaine or ecgonine may be synthesized or made) contained in such additional amounts of coca leaves imported under this subsection shall be destroyed under the supervision of an [authorized](/usc/21/360eee–1.md?p=a-6) representative of the Attorney General. - (d) **Application for increased importation of ephedrine, pseudoephedrine, or phenylpropanolamine—** - (1) With respect to a registrant under [section 958 of this title](/usc/21/958.md) who is [authorized](/usc/21/360eee–1.md?p=a-6) under [subsection (a)(1)](#a-1) to [import](/usc/21/951.md?p=a-1) ephedrine, pseudoephedrine, or phenylpropanolamine, at any time during the year the registrant may apply for an increase in the amount of such chemical that the registrant is [authorized](/usc/21/360eee–1.md?p=a-6) to [import](/usc/21/951.md?p=a-1), and the Attorney General may approve the application if the Attorney General determines that the approval is necessary to provide for medical, scientific, or other legitimate purposes regarding the chemical. - (2) With respect to the application under [paragraph (1)](#d-1): - (A) Not later than 60 days after receiving the application, the Attorney General shall approve or deny the application. - (B) In approving the application, the Attorney General shall specify the period of time for which the approval is in effect, or shall provide that the approval is effective until the registrant involved is notified in writing by the Attorney General that the approval is terminated. - (C) If the Attorney General does not approve or deny the application before the expiration of the 60-day period under [subparagraph (A)](#d-2-A), the application is deemed to be approved, and such approval remains in effect until the Attorney General notifies the registrant in writing that the approval is terminated. - (e) **Reference to ephedrine, pseudoephedrine, or phenylpropanolamine—** Each reference in this section to ephedrine, pseudoephedrine, or phenylpropanolamine includes each of the salts, optical isomers, and salts of optical isomers of such chemical. # §953. Exportation of controlled substances - (a) **Narcotic drugs in schedule I, II, III, or IV—** It shall be unlawful to export from the United States any [narcotic drug](/usc/21/1907.md?p=4) in schedule I, II, III, or IV unless— - (1) it is exported to a country which is a party to— - (A) the International Opium Convention of 1912 for the Suppression of the Abuses of Opium, Morphine, Cocaine, and Derivative [Drugs](/usc/21/321.md?p=g-1), or to the International Opium Convention signed at Geneva on February 19, 1925; or - (B) the Convention for Limiting the Manufacture and Regulating the [Distribution](/usc/21/360eee.md?p=5) of [Narcotic Drugs](/usc/21/1907.md?p=4) concluded at Geneva, July 13, 1931, as amended by the protocol signed at Lake Success on December 11, 1946, and the protocol bringing under international control [drugs](/usc/21/321.md?p=g-1) outside the scope of the convention of July 13, 1931, for limiting the manufacture and regulating the [distribution](/usc/21/360eee.md?p=5) of [narcotic drugs](/usc/21/1907.md?p=4) (as amended by the protocol signed at Lake Success on December 11, 1946), signed at Paris, November 19, 1948; or - (C) the Single Convention on [Narcotic Drugs](/usc/21/1907.md?p=4), 1961, signed at New York, March 30, 1961; - (2) such country has instituted and maintains, in conformity with the conventions to which it is a party, a system for the control of [imports](/usc/21/951.md?p=a-1) of [narcotic drugs](/usc/21/1907.md?p=4) which the Attorney General deems adequate; - (3) the [narcotic drug](/usc/21/1907.md?p=4) is consigned to a holder of such permits or licenses as may be required under the laws of the country of [import](/usc/21/951.md?p=a-1), and a permit or license to [import](/usc/21/951.md?p=a-1) such [drug](/usc/21/321.md?p=g-1) has been issued by the country of [import](/usc/21/951.md?p=a-1); - (4) substantial evidence is furnished to the Attorney General by the exporter that (A) the [narcotic drug](/usc/21/1907.md?p=4) is to be applied exclusively to medical or scientific uses within the country of [import](/usc/21/951.md?p=a-1), and (B) there is an actual need for the [narcotic drug](/usc/21/1907.md?p=4) for medical or scientific uses within such country; and - (5) a permit to export the [narcotic drug](/usc/21/1907.md?p=4) in each instance has been issued by the Attorney General. - (b) **Exception for exportation for special scientific purposes—** Notwithstanding [subsection (a)](#a), the Attorney General may authorize any [narcotic drug](/usc/21/1907.md?p=4) (including crude opium and coca leaves) in schedule I, II, III, or IV to be exported from the United States to a country which is a party to any of the international instruments mentioned in [subsection (a)](#a) if the particular [drug](/usc/21/321.md?p=g-1) is to be applied to a special scientific purpose in the country of destination and the authorities of such country will permit the importation of the particular [drug](/usc/21/321.md?p=g-1) for such purpose. - (c) **Nonnarcotic controlled substances in schedule I or II—** It shall be unlawful to export from the United States any nonnarcotic [controlled substance](/usc/21/889.md?p=a-1) in schedule I or II unless— - (1) it is exported to a country which has instituted and maintains a system which the Attorney General deems adequate for the control of [imports](/usc/21/951.md?p=a-1) of such substances; - (2) the [controlled substance](/usc/21/889.md?p=a-1) is consigned to a holder of such permits or licenses as may be required under the laws of the country of [import](/usc/21/951.md?p=a-1); - (3) substantial evidence is furnished to the Attorney General that (A) the [controlled substance](/usc/21/889.md?p=a-1) is to be applied exclusively to medical, scientific, or other legitimate uses within the country to which exported, (B) it will not be exported from such country, and (C) there is an actual need for the [controlled substance](/usc/21/889.md?p=a-1) for medical, scientific, or other legitimate uses within the country; and - (4) a permit to export the [controlled substance](/usc/21/889.md?p=a-1) in each instance has been issued by the Attorney General. - (d) **Exception for exportation for special scientific purposes—** Notwithstanding [subsection (c)](#c), the Attorney General may authorize any nonnarcotic [controlled substance](/usc/21/889.md?p=a-1) in schedule I or II to be exported from the United States if the particular substance is to be applied to a special scientific purpose in the country of destination and the authorities of such country will permit the importation of the particular [drug](/usc/21/321.md?p=g-1) for such purpose. - (e) **Nonnarcotic controlled substances in schedule III or IV; controlled substances in schedule V—** It shall be unlawful to export from the United States to any other country any nonnarcotic [controlled substance](/usc/21/889.md?p=a-1) in schedule III or IV or any [controlled substances](/usc/21/889.md?p=a-1) in schedule V unless— - (1) there is furnished (before export) to the Attorney General documentary proof that importation is not contrary to the laws or regulations of the country of destination for consumption for medical, scientific, or other legitimate purposes; - (2) it is exported pursuant to such notification or declaration, or in the case of any nonnarcotic [controlled substance](/usc/21/889.md?p=a-1) in schedule III, such export permit, notification, or declaration as the Attorney General may by regulation prescribe; and - (3) in the case of a nonnarcotic [controlled substance](/usc/21/889.md?p=a-1) in schedule IV or V which is also listed in schedule I or II of the Convention on Psychotropic Substances, it is exported pursuant to such export permit requirements, prescribed by regulation of the Attorney General, as are required by the Convention. - (f) **Exception for exportation for subsequent export—** Notwithstanding subsections [(a)(4)](#a-4) and [(c)(3)](#c-3), the Attorney General may authorize any [controlled substance](/usc/21/889.md?p=a-1) that is in schedule I or II, or is a [narcotic drug](/usc/21/1907.md?p=4) in schedule III or IV, to be exported from the United States to a country for subsequent export from that country to another country, if each of the following conditions is met: - (1) Both the country to which the [controlled substance](/usc/21/889.md?p=a-1) is exported from the United States (referred to in this subsection as the “first country”) and the country to which the [controlled substance](/usc/21/889.md?p=a-1) is exported from the first country (referred to in this subsection as the “second country”) are parties to the Single Convention on [Narcotic Drugs](/usc/21/1907.md?p=4), 1961, and the Convention on Psychotropic Substances, 1971. - (2) The first country and the second country have each instituted and maintain, in conformity with such Conventions, a system of controls of [imports](/usc/21/951.md?p=a-1) of [controlled substances](/usc/21/889.md?p=a-1) which the Attorney General deems adequate. - (3) With respect to the first country, the [controlled substance](/usc/21/889.md?p=a-1) is consigned to a holder of such permits or licenses as may be required under the laws of such country, and a permit or license to [import](/usc/21/951.md?p=a-1) the [controlled substance](/usc/21/889.md?p=a-1) has been issued by the country. - (4) With respect to the second country, substantial evidence is furnished to the Attorney General by the [person](/usc/21/379j–21.md?p=k-10) who will export the [controlled substance](/usc/21/889.md?p=a-1) from the United States that— - (A) the [controlled substance](/usc/21/889.md?p=a-1) is to be consigned to a holder of such permits or licenses as may be required under the laws of such country, and a permit or license to [import](/usc/21/951.md?p=a-1) the [controlled substance](/usc/21/889.md?p=a-1) is to be issued by the country; and - (B) the [controlled substance](/usc/21/889.md?p=a-1) is to be applied exclusively to medical, scientific, or other legitimate uses within the country. - (5) - (A) The [controlled substance](/usc/21/889.md?p=a-1) will not be exported from the second country, except that the [controlled substance](/usc/21/889.md?p=a-1) may be exported from a second country that is a member of the European Economic Area to another country that is a member of the European Economic Area, provided that the first country is also a member of the European Economic Area. - (B) Subsequent to any re-exportation described in [subparagraph (A)](#f-5-A), a [controlled substance](/usc/21/889.md?p=a-1) may continue to be exported from any country that is a member of the European Economic Area to any other such country, if— - (i) the conditions applicable with respect to the first country under paragraphs [(1)](#f-1), [(2)](#f-2), [(3)](#f-3), [(4)](#f-4), [(6)](#f-6), and [(7)](#f-7) are met by each subsequent country from which the [controlled substance](/usc/21/889.md?p=a-1) is exported pursuant to this paragraph; and - (ii) the conditions applicable with respect to the second country under paragraphs [(1)](#f-1), [(2)](#f-2), [(3)](#f-3), [(4)](#f-4), [(6)](#f-6), and [(7)](#f-7) are met by each subsequent country to which the [controlled substance](/usc/21/889.md?p=a-1) is exported pursuant to this paragraph. - (6) - (A) Within 30 days after the [controlled substance](/usc/21/889.md?p=a-1) is exported from the first country to the second country, the [person](/usc/21/379j–21.md?p=k-10) who exported the [controlled substance](/usc/21/889.md?p=a-1) from the United States delivers to the Attorney General documentation certifying that such export from the first country has occurred. - (B) In the case of re-exportation among members of the European Economic Area, within 30 days after each re-exportation, the [person](/usc/21/379j–21.md?p=k-10) who exported the [controlled substance](/usc/21/889.md?p=a-1) from the United States delivers to the Attorney General— - (i) documentation certifying that such re-exportation has occurred; and - (ii) information concerning the consignee, country, and product. - (7) A permit to export the [controlled substance](/usc/21/889.md?p=a-1) from the United States has been issued by the Attorney General. - (g) **Limitation—** Subject to paragraphs [(5)](#f-5) and [(6)](#f-6) of subsection (f) in the case of any [controlled substance](/usc/21/889.md?p=a-1) in schedule I or II or any [narcotic drug](/usc/21/1907.md?p=4) in schedule III or IV, the Attorney General shall not promulgate nor enforce any regulation, subregulatory guidance, or enforcement policy which impedes re-exportation of any [controlled substance](/usc/21/889.md?p=a-1) among European Economic Area countries, including by promulgating or enforcing any requirement that— - (1) re-exportation from the first country to the second country or re-exportation from the second country to another country occur within a specified period of time; or - (2) information concerning the consignee, country, and product be provided prior to exportation of the [controlled substance](/usc/21/889.md?p=a-1) from the United States or prior to each re-exportation among members of the European Economic Area. # §954. Transshipment and in-transit shipment of controlled substances Notwithstanding sections [952](/usc/21/952.md), [953](/usc/21/953.md), and [957](/usc/21/957.md) of this title— - (1) A [controlled substance](/usc/21/889.md?p=a-1) in schedule I may— - (A) be imported into the United States for transshipment to another country, or - (B) be transferred or transshipped from one vessel, vehicle, or aircraft to another vessel, vehicle, or aircraft within the United States for immediate exportation, if and only if it is so imported, transferred, or transshipped (i) for scientific, medical, or other legitimate purposes in the country of destination, and (ii) with the prior written approval of the Attorney General (which shall be granted or denied within 21 days of the request). - (2) A [controlled substance](/usc/21/889.md?p=a-1) in schedule II, III, or IV may be so imported, transferred, or transshipped if and only if advance notice is given to the Attorney General in accordance with regulations of the Attorney General. # §955. Possession on board vessels, etc., arriving in or departing from United States It shall be unlawful for any [person](/usc/21/379j–21.md?p=k-10) to bring or possess on board any vessel or aircraft, or on board any vehicle of a carrier, arriving in or departing from the United States or the [customs territory of the United States](/usc/21/951.md?p=a-2), a [controlled substance](/usc/21/889.md?p=a-1) in schedule I or II or a [narcotic drug](/usc/21/1907.md?p=4) in schedule III or IV, unless such substance or [drug](/usc/21/321.md?p=g-1) is a part of the cargo entered in the manifest or part of the official supplies of the vessel, aircraft, or vehicle. # [§§955a to 955d. Transferred — transferred] # §956. Exemption authority - (a) **Individual possessing controlled substance—** - (1) Subject to [paragraph (2)](#a-2), the Attorney General may by regulation exempt from sections [952(a)](/usc/21/952.md?p=a) and [(b)](/usc/21/952.md?p=b), [953](/usc/21/953.md), [954](/usc/21/954.md), and [955](/usc/21/955.md) of this title any individual who has a [controlled substance](/usc/21/889.md?p=a-1) (except a substance in schedule I) in his possession for his personal medical use, or for administration to an animal accompanying him, if he lawfully obtained such substance and he makes such declaration (or gives such other notification) as the Attorney General may by regulation require. - (2) Notwithstanding any exemption under [paragraph (1)](#a-1), a United States resident who enters the United States through an international land border with a [controlled substance](/usc/21/889.md?p=a-1) (except a substance in schedule I) for which the individual does not possess a valid prescription issued by a practitioner (as defined in [section 802 of this title](/usc/21/802.md)) in accordance with applicable Federal and [State](/usc/21/321.md?p=a-1) law (or documentation that [verifies](/usc/21/360eee.md?p=28) the issuance of such a prescription to that individual) may not [import](/usc/21/951.md?p=a-1) the [controlled substance](/usc/21/889.md?p=a-1) into the United States in an amount that exceeds 50 dosage units of the [controlled substance](/usc/21/889.md?p=a-1). - (b) **Compound, mixture, or preparation—** The Attorney General may by regulation except any compound, mixture, or preparation containing any depressant or stimulant substance listed in paragraph [(a)](#a) or [(b)](#b) of schedule III or in schedule IV or V from the application of all or any part of this subchapter if (1) the compound, mixture, or preparation contains one or more active medicinal ingredients not having a depressant or stimulant effect on the central nervous system, and (2) such ingredients are included therein in such combinations, quantity, proportion, or concentration as to vitiate the potential for abuse of the substances which do have a depressant or stimulant effect on the central nervous system. # §957. Persons required to register - (a) **Coverage—** No [person](/usc/21/379j–21.md?p=k-10) may— - (1) [import](/usc/21/951.md?p=a-1) into the [customs territory of the United States](/usc/21/951.md?p=a-2) from any place outside thereof (but within the United States), or [import](/usc/21/951.md?p=a-1) into the United States from any place outside thereof, any [controlled substance](/usc/21/889.md?p=a-1) or list I chemical, or - (2) export from the United States any [controlled substance](/usc/21/889.md?p=a-1) or list I chemical, unless there is in effect with respect to such [person](/usc/21/379j–21.md?p=k-10) a registration issued by the Attorney General under [section 958 of this title](/usc/21/958.md), or unless such [person](/usc/21/379j–21.md?p=k-10) is exempt from registration under [subsection (b)](#b). - (b) **Exemptions—** - (1) The following [persons](/usc/21/379j–21.md?p=k-10) shall not be required to register under the provisions of this section and may lawfully possess a [controlled substance](/usc/21/889.md?p=a-1) or list I chemical: - (A) An agent or an employee of any importer or exporter registered under [section 958 of this title](/usc/21/958.md) if such agent or employee is acting in the usual course of his business or employment. - (B) A common or contract carrier or warehouseman, or an employee thereof, whose possession of any [controlled substance](/usc/21/889.md?p=a-1) or list I chemical is in the usual course of his business or employment. - (C) An ultimate user who possesses such substance for a purpose specified in [section 802(25)](/usc/21/802.md?p=25)[^1] of this title and in conformity with an exemption granted under [section 956(a) of this title](/usc/21/956.md?p=a). - (2) The Attorney General may, by regulation, waive the requirement for registration of certain importers and exporters if he finds it consistent with the public health and safety; and may authorize any such importer or exporter to possess [controlled substances](/usc/21/889.md?p=a-1) or list I chemicals for purposes of importation and exportation. # §958. Registration requirements - (a) **Applicants to import or export controlled substances in schedule I or II—** The Attorney General shall register an applicant to [import](/usc/21/951.md?p=a-1) or export a [controlled substance](/usc/21/889.md?p=a-1) in schedule I or II if he determines that such registration is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. In determining the public interest, the factors enumerated in paragraph (1) through (6) of [section 823(a) of this title](/usc/21/823.md?p=a) shall be considered. - (b) **Activity limited to specified substances—** Registration granted under this section shall not entitle a registrant to [import](/usc/21/951.md?p=a-1) or export [controlled substances](/usc/21/889.md?p=a-1) other than specified in the registration. - (c) **Applicants to import controlled substances in schedule III, IV, or V or to export controlled substances in schedule III or IV; applicants to import or export list I chemicals—** - (1) The Attorney General shall register an applicant to [import](/usc/21/951.md?p=a-1) a [controlled substance](/usc/21/889.md?p=a-1) in schedule III, IV, or V or to export a [controlled substance](/usc/21/889.md?p=a-1) in schedule III or IV, unless he determines that the issuance of such registration is inconsistent with the public interest. In determining the public interest, the factors enumerated in paragraphs (1) through (6) of [section 823(e) of this title](/usc/21/823.md?p=e) shall be considered. - (2) - (A) The Attorney General shall register an applicant to [import](/usc/21/951.md?p=a-1) or export a list I chemical unless the Attorney General determines that registration of the applicant is inconsistent with the public interest. Registration under this subsection shall not be required for the [import](/usc/21/951.md?p=a-1) or export of a [drug product](/usc/21/321.md?p=dd) that is exempted under [section 802(39)(A)(iv) of this title](/usc/21/802.md?p=39-A-iv). - (B) In determining the public interest for the purposes of [subparagraph (A)](#c-2-A), the Attorney General shall consider the factors specified in [section 823(i) of this title](/usc/21/823.md?p=i). - (d) **Denial of application—** - (1) The Attorney General may deny an application for registration under [subsection (a)](#a) if he is unable to determine that such registration is consistent with the public interest (as defined in [subsection (a)](#a)) and with the United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. - (2) The Attorney General may deny an application for registration under [subsection (c)](#c), or revoke or suspend a registration under subsection [(a)](#a) or [(c)](#c), if he determines that such registration is inconsistent with the public interest (as defined in subsection [(a)](#a) or [(c)](#c)) or with the United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. - (3) The Attorney General may limit the revocation or suspension of a registration to the particular [controlled substance](/usc/21/889.md?p=a-1), or substances, or list I chemical or chemicals, with respect to which grounds for revocation or suspension exist. - (4) Before taking action pursuant to this subsection, the Attorney General shall serve upon the applicant or registrant an order to show cause as to why the registration should not be denied, revoked, or suspended. The order to show cause shall contain a statement of the basis thereof and shall call upon the applicant or registrant to appear before the Attorney General, or his designee, at a time and place stated in the order, but in no event less than thirty days after the date of receipt of the order. Proceedings to deny, revoke, or suspend shall be conducted pursuant to this subsection in accordance with subchapter II of [chapter 5](/usc/5/chptI-ch5.md) of title 5. Such proceedings shall be independent of, and not in lieu of, criminal prosecutions or other proceedings under this subchapter or any other law of the United States. - (5) The Attorney General may, in his discretion, suspend any registration simultaneously with the institution of proceedings under this subsection, in cases where he finds that there is an imminent danger to the public health and safety. Such suspension shall continue in effect until the conclusion of such proceedings, including judicial review thereof, unless sooner withdrawn by the Attorney General or dissolved by a court of competent jurisdiction. - (6) In the event that the Attorney General suspends or revokes a registration granted under this section, all [controlled substances](/usc/21/889.md?p=a-1) or list I chemicals owned or possessed by the registrant pursuant to such registration at the time of suspension or the effective date of the revocation order, as the case may be, may, in the discretion of the Attorney General, be seized or placed under seal. No disposition may be made of any [controlled substances](/usc/21/889.md?p=a-1) or list I chemicals under seal until the time for taking an appeal has elapsed or until all appeals have been concluded, except that a court, upon application therefor, may at any time order the sale of perishable [controlled substances](/usc/21/889.md?p=a-1) or list I chemicals. Any such order shall require the deposit of the proceeds of the sale with the court. Upon a revocation order becoming final, all such [controlled substances](/usc/21/889.md?p=a-1) or list I chemicals (or proceeds of the sale thereof which have been deposited with the court) shall be forfeited to the United States; and the Attorney General shall dispose of such [controlled substances](/usc/21/889.md?p=a-1) or list I chemicals in accordance with [section 881(e) of this title](/usc/21/881.md?p=e). - (e) **Registration period—** No registration shall be issued under this subchapter for a period in excess of one year. Unless the regulations of the Attorney General otherwise provide, sections [822(f)](/usc/21/822.md?p=f), [825](/usc/21/825.md), [827](/usc/21/827.md), and [830](/usc/21/830.md) of this title shall apply to [persons](/usc/21/379j–21.md?p=k-10) registered under this section to the same extent such sections apply to [persons](/usc/21/379j–21.md?p=k-10) registered under [section 823 of this title](/usc/21/823.md). - (f) **Rules and regulations—** The Attorney General is [authorized](/usc/21/360eee–1.md?p=a-6) to promulgate rules and regulations and to charge reasonable fees relating to the registration and control of importers and exporters of [controlled substances](/usc/21/889.md?p=a-1) or [listed chemicals](/usc/21/1907.md?p=4). - (g) **Scope of authorized activity—** [Persons](/usc/21/379j–21.md?p=k-10) registered by the Attorney General under this section to [import](/usc/21/951.md?p=a-1) or export [controlled substances](/usc/21/889.md?p=a-1) or list I chemicals may [import](/usc/21/951.md?p=a-1) or export (and for the purpose of so importing or exporting, may possess) such substances to the extent [authorized](/usc/21/360eee–1.md?p=a-6) by their registration and in conformity with the other provisions of this subchapter and subchapter I. - (h) **Separate registrations for each principal place of business—** A separate registration shall be required at each principal place of business where the applicant [imports](/usc/21/951.md?p=a-1) or exports [controlled substances](/usc/21/889.md?p=a-1) or list I chemicals. - (i) **Emergency situations—** Except in emergency situations as described in [section 952(a)(2)(A) of this title](/usc/21/952.md?p=a-2-A), prior to issuing a registration under this section to a bulk manufacturer of a [controlled substance](/usc/21/889.md?p=a-1) in schedule I or II, and prior to issuing a regulation under [section 952(a) of this title](/usc/21/952.md?p=a) authorizing the importation of such a substance, the Attorney General shall give manufacturers holding registrations for the bulk manufacture of the substance an opportunity for a hearing. # §959. Possession, manufacture, or distribution of controlled substance - (a) **Manufacture or distribution for purpose of unlawful importation—** It shall be unlawful for any [person](/usc/21/379j–21.md?p=k-10) to manufacture or [distribute](/usc/21/360eee.md?p=5) a [controlled substance](/usc/21/889.md?p=a-1) in schedule I or II or flunitrazepam or a [listed chemical](/usc/21/1907.md?p=4) intending, knowing, or having reasonable cause to believe that such substance or chemical will be unlawfully imported into the United States or into waters within a distance of 12 miles of the coast of the United States. - (b) **Manufacture or distribution of listed chemical for purpose of manufacture or unlawful importation of controlled substance—** It shall be unlawful for any [person](/usc/21/379j–21.md?p=k-10) to manufacture or [distribute](/usc/21/360eee.md?p=5) a [listed chemical](/usc/21/1907.md?p=4)— - (1) intending or knowing that the [listed chemical](/usc/21/1907.md?p=4) will be used to manufacture a [controlled substance](/usc/21/889.md?p=a-1); and - (2) intending, knowing, or having reasonable cause to believe that the [controlled substance](/usc/21/889.md?p=a-1) will be unlawfully imported into the United States. - (c) **Possession, manufacture, or distribution by person on board aircraft—** It shall be unlawful for any United States citizen on board any aircraft, or any [person](/usc/21/379j–21.md?p=k-10) on board an aircraft owned by a United States citizen or registered in the United States, to— - (1) manufacture or [distribute](/usc/21/360eee.md?p=5) a [controlled substance](/usc/21/889.md?p=a-1) or [listed chemical](/usc/21/1907.md?p=4); or - (2) possess a [controlled substance](/usc/21/889.md?p=a-1) or [listed chemical](/usc/21/1907.md?p=4) with intent to [distribute](/usc/21/360eee.md?p=5). - (d) **Acts committed outside territorial jurisdiction of United States—** This section is intended to reach acts of manufacture or [distribution](/usc/21/360eee.md?p=5) committed outside the territorial jurisdiction of the United States. # §960. Prohibited acts A - (a) **Unlawful acts—** Any [person](/usc/21/379j–21.md?p=k-10) who— - (1) contrary to section [825](/usc/21/825.md), [952](/usc/21/952.md), [953](/usc/21/953.md), or [957](/usc/21/957.md) of this title, knowingly or intentionally [imports](/usc/21/951.md?p=a-1) or exports a [controlled substance](/usc/21/889.md?p=a-1), - (2) contrary to [section 955 of this title](/usc/21/955.md), knowingly or intentionally brings or possesses on board a vessel, aircraft, or vehicle a [controlled substance](/usc/21/889.md?p=a-1), or - (3) contrary to [section 959 of this title](/usc/21/959.md), manufactures, possesses with intent to [distribute](/usc/21/360eee.md?p=5), or [distributes](/usc/21/360eee.md?p=5) a [controlled substance](/usc/21/889.md?p=a-1), shall be punished as provided in [subsection (b)](#b). - (b) **Penalties—** - (1) In the case of a violation of [subsection (a)](#a) of this section involving— - (A) 1 kilogram or more of a mixture or substance containing a detectable amount of heroin; - (B) 5 kilograms or more of a mixture or substance containing a detectable amount of— - (i) coca leaves, except coca leaves and extracts of coca leaves from which cocaine, ecgonine, and derivatives of ecgonine or their salts have been removed; - (ii) cocaine, its salts, optical and geometric isomers, and salts or isomers; - (iii) ecgonine, its derivatives, their salts, isomers, and salts of isomers; or - (iv) any compound, mixture, or preparation which contains any quantity of any of the substances referred to in [clauses (i) through (iii)](#b-1-B-i..b-1-B-iii); - (C) 280 grams or more of a mixture or substance described in [subparagraph (B)](#b-1-B) which contains cocaine base; - (D) 100 grams or more of phencyclidine (PCP) or 1 kilogram or more of a mixture or substance containing a detectable amount of phencyclidine (PCP); - (E) 10 grams or more of a mixture or substance containing a detectable amount of lysergic acid diethylamide (LSD); - (F) 400 grams or more of a mixture or substance containing a detectable amount of N-phenyl-N- [1- ( 2-phenylethyl ) -4-piperidinyl] propanamide or 100 grams or more of a mixture or substance containing a detectable amount of any analogue of N-phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] propanamide or a fentanyl-related substance; - (G) 1000 kilograms or more of a mixture or substance containing a detectable amount of marihuana; or - (H) 50 grams or more of methamphetamine, its salts, isomers, and salts of its isomers or 500 grams or more of a mixture or substance containing a detectable amount of methamphetamine, its salts, isomers, or salts of its isomers.[^1] the [person](/usc/21/379j–21.md?p=k-10) committing such violation shall be sentenced to a term of imprisonment of not less than 10 years and not more than life and if death or serious bodily injury results from the use of such substance shall be sentenced to a term of imprisonment of not less than 20 years and not more than life, a fine not to exceed the greater of that [authorized](/usc/21/360eee–1.md?p=a-6) in accordance with the provisions of [title 18](/usc/18.md) or $10,000,000 if the defendant is an individual or $50,000,000 if the defendant is other than an individual, or both. If any [person](/usc/21/379j–21.md?p=k-10) commits such a violation after a prior conviction for a serious [drug](/usc/21/321.md?p=g-1) felony or serious violent felony has become final, such [person](/usc/21/379j–21.md?p=k-10) shall be sentenced to a term of imprisonment of not less than 15 years and not more than life imprisonment and if death or serious bodily injury results from the use of such substance shall be sentenced to life imprisonment, a fine not to exceed the greater of twice that [authorized](/usc/21/360eee–1.md?p=a-6) in accordance with the provisions of [title 18](/usc/18.md) or $20,000,000 if the defendant is an individual or $75,000,000 if the defendant is other than an individual, or both. Notwithstanding [section 3583 of title 18](/usc/18/3583.md), any sentence under this paragraph shall, in the absence of such a prior conviction, impose a term of supervised release of at least 5 years in addition to such term of imprisonment and shall, if there was such a prior conviction, impose a term of supervised release of at least 10 years in addition to such term of imprisonment. Notwithstanding any other provision of law, the court shall not place on probation or suspend the sentence of any [person](/usc/21/379j–21.md?p=k-10) sentenced under this paragraph. No [person](/usc/21/379j–21.md?p=k-10) sentenced under this paragraph shall be eligible for parole during the term of imprisonment imposed therein. - (2) In the case of a violation of [subsection (a)](#a) of this section involving— - (A) 100 grams or more of a mixture or substance containing a detectable amount of heroin; - (B) 500 grams or more of a mixture or substance containing a detectable amount of— - (i) coca leaves, except coca leaves and extracts of coca leaves from which cocaine, ecgonine, and derivatives of ecgonine or their salts have been removed; - (ii) cocaine, its salts, optical and geometric isomers, and salts or isomers; - (iii) ecgonine, its derivatives, their salts, isomers, and salts of isomers; or - (iv) any compound, mixture, or preparation which contains any quantity of any of the substances referred to in [clauses (i) through (iii)](#b-2-B-i..b-2-B-iii); - (C) 28 grams or more of a mixture or substance described in [subparagraph (B)](#b-2-B) which contains cocaine base; - (D) 10 grams or more of phencyclidine (PCP) or 100 grams or more of a mixture or substance containing a detectable amount of phencyclidine (PCP); - (E) 1 gram or more of a mixture or substance containing a detectable amount of lysergic acid diethylamide (LSD); - (F) 40 grams or more of a mixture or substance containing a detectable amount of N-phenyl-N- [1- ( 2-phenylethyl ) -4-piperidinyl] propanamide or 10 grams or more of a mixture or substance containing a detectable amount of any analogue of N-phenyl-N-[1-(2-phenylethyl)-4-piperidinyl] propanamide or a fentanyl-related substance; - (G) 100 kilograms or more of a mixture or substance containing a detectable amount of marihuana; or - (H) 5 grams or more of methamphetamine, its salts, isomers, and salts of its isomers or 50 grams or more of a mixture or substance containing a detectable amount of methamphetamine, its salts, isomers, or salts of its isomers.[^1] the [person](/usc/21/379j–21.md?p=k-10) committing such violation shall be sentenced to a term of imprisonment of not less than 5 years and not more than 40 years and if death or serious bodily injury results from the use of such substance shall be sentenced to a term of imprisonment of not less than twenty years and not more than life, a fine not to exceed the greater of that [authorized](/usc/21/360eee–1.md?p=a-6) in accordance with the provisions of [title 18](/usc/18.md) or $5,000,000 if the defendant is an individual or $25,000,000 if the defendant is other than an individual, or both. If any [person](/usc/21/379j–21.md?p=k-10) commits such a violation after a prior conviction for a serious [drug](/usc/21/321.md?p=g-1) felony or serious violent felony has become final, such [person](/usc/21/379j–21.md?p=k-10) shall be sentenced to a term of imprisonment of not less than 10 years and not more than life imprisonment and if death or serious bodily injury results from the use of such substance shall be sentenced to life imprisonment, a fine not to exceed the greater of twice that [authorized](/usc/21/360eee–1.md?p=a-6) in accordance with the provisions of [title 18](/usc/18.md) or $8,000,000 if the defendant is an individual or $50,000,000 if the defendant is other than an individual, or both. Notwithstanding [section 3583 of title 18](/usc/18/3583.md), any sentence imposed under this paragraph shall, in the absence of such a prior conviction, include a term of supervised release of at least 4 years in addition to such term of imprisonment and shall, if there was such a prior conviction, include a term of supervised release of at least 8 years in addition to such term of imprisonment. Notwithstanding any other provision of law, the court shall not place on probation or suspend the sentence of any [person](/usc/21/379j–21.md?p=k-10) sentenced under this paragraph. No [person](/usc/21/379j–21.md?p=k-10) sentenced under this paragraph shall be eligible for parole during the term of imprisonment imposed therein. - (3) In the case of a violation under [subsection (a)](#a) of this section involving a [controlled substance](/usc/21/889.md?p=a-1) in schedule I or II, gamma hydroxybutyric acid (including when scheduled as an approved [drug product](/usc/21/321.md?p=dd) for purposes of section 3(a)(1)(B) of the Hillory J. Farias and Samantha Reid Date-Rape [Drug](/usc/21/321.md?p=g-1) Prohibition Act of 2000), or flunitrazepam, the [person](/usc/21/379j–21.md?p=k-10) committing such violation shall, except as provided in paragraphs [(1)](#b-1), [(2)](#b-2), and [(4)](#b-4), be sentenced to a term of imprisonment of not more than 20 years and if death or serious bodily injury results from the use of such substance shall be sentenced to a term of imprisonment of not less than twenty years and not more than life, a fine not to exceed the greater of that [authorized](/usc/21/360eee–1.md?p=a-6) in accordance with the provisions of [title 18](/usc/18.md) or $1,000,000 if the defendant is an individual or $5,000,000 if the defendant is other than an individual, or both. If any [person](/usc/21/379j–21.md?p=k-10) commits such a violation after a prior conviction for a felony [drug](/usc/21/321.md?p=g-1) offense has become final, such [person](/usc/21/379j–21.md?p=k-10) shall be sentenced to a term of imprisonment of not more than 30 years and if death or serious bodily injury results from the use of such substance shall be sentenced to life imprisonment, a fine not to exceed the greater of twice that [authorized](/usc/21/360eee–1.md?p=a-6) in accordance with the provisions of [title 18](/usc/18.md) or $2,000,000 if the defendant is an individual or $10,000,000 if the defendant is other than an individual, or both. Notwithstanding [section 3583 of title 18](/usc/18/3583.md), any sentence imposing a term of imprisonment under this paragraph shall, in the absence of such a prior conviction, impose a term of supervised release of at least 3 years in addition to such term of imprisonment and shall, if there was such a prior conviction, impose a term of supervised release of at least 6 years in addition to such term of imprisonment. Notwithstanding the prior sentence, and notwithstanding any other provision of law, the court shall not place on probation or suspend the sentence of any [person](/usc/21/379j–21.md?p=k-10) sentenced under the provisions of this paragraph which provide for a mandatory term of imprisonment if death or serious bodily injury results. - (4) In the case of a violation under [subsection (a)](#a) with respect to less than 50 kilograms of marihuana, except in the case of 100 or more marihuana plants regardless of weight, less than 10 kilograms of hashish, or less than one kilogram of hashish oil, the [person](/usc/21/379j–21.md?p=k-10) committing such violation shall be sentenced in accordance with [section 841(b)(1)(D) of this title](/usc/21/841.md?p=b-1-D). - (5) In the case of a violation of [subsection (a)](#a) involving a [controlled substance](/usc/21/889.md?p=a-1) in schedule III, such [person](/usc/21/379j–21.md?p=k-10) shall be sentenced in accordance with [section 841(b)(1) of this title](/usc/21/841.md?p=b-1). - (6) In the case of a violation of [subsection (a)](#a) involving a [controlled substance](/usc/21/889.md?p=a-1) in schedule IV, such [person](/usc/21/379j–21.md?p=k-10) shall be sentenced in accordance with [section 841(b)(2) of this title](/usc/21/841.md?p=b-2). - (7) In the case of a violation of [subsection (a)](#a) involving a [controlled substance](/usc/21/889.md?p=a-1) in schedule V, such [person](/usc/21/379j–21.md?p=k-10) shall be sentenced in accordance with [section 841(b)(3) of this title](/usc/21/841.md?p=b-3). - (c) **Repealed. Pub. L. 98–473, title II, § 225, formerly § 225(a), Oct. 12, 1984, 98 Stat. 2030, as amended by Pub. L. 99–570, title I, § 1005(c), Oct. 27, 1986, 100 Stat. 3207–6—** - (d) **Penalty for importation or exportation—** A [person](/usc/21/379j–21.md?p=k-10) who knowingly or intentionally— - (1) [imports](/usc/21/951.md?p=a-1) or exports a [listed chemical](/usc/21/1907.md?p=4) with intent to manufacture a [controlled substance](/usc/21/889.md?p=a-1) in violation of this subchapter or subchapter I; - (2) exports a [listed chemical](/usc/21/1907.md?p=4) in violation of the laws of the country to which the chemical is exported or serves as a broker or trader for an international transaction involving a [listed chemical](/usc/21/1907.md?p=4), if the transaction is in violation of the laws of the country to which the chemical is exported; - (3) [imports](/usc/21/951.md?p=a-1) or exports a [listed chemical](/usc/21/1907.md?p=4) knowing, or having reasonable cause to believe, that the chemical will be used to manufacture a [controlled substance](/usc/21/889.md?p=a-1) in violation of this subchapter or subchapter I; - (4) exports a [listed chemical](/usc/21/1907.md?p=4), or serves as a broker or trader for an international transaction involving a [listed chemical](/usc/21/1907.md?p=4), knowing, or having reasonable cause to believe, that the chemical will be used to manufacture a [controlled substance](/usc/21/889.md?p=a-1) in violation of the laws of the country to which the chemical is exported; - (5) [imports](/usc/21/951.md?p=a-1) or exports a [listed chemical](/usc/21/1907.md?p=4), with the intent to evade the reporting or recordkeeping requirements of [section 971 of this title](/usc/21/971.md) applicable to such importation or exportation by falsely representing to the Attorney General that the importation or exportation qualifies for a waiver of the 15-day notification requirement granted pursuant to paragraph (2) or (3) of [section 971(f) of this title](/usc/21/971.md?p=f) by misrepresenting the actual country of final destination of the [listed chemical](/usc/21/1907.md?p=4) or the actual [listed chemical](/usc/21/1907.md?p=4) being imported or exported; - (6) [imports](/usc/21/951.md?p=a-1) a [listed chemical](/usc/21/1907.md?p=4) in violation of [section 952 of this title](/usc/21/952.md), [imports](/usc/21/951.md?p=a-1) or exports such a chemical in violation of section [957](/usc/21/957.md) or [971](/usc/21/971.md) of this title, or transfers such a chemical in violation of [section 971(d) of this title](/usc/21/971.md?p=d); or - (7) manufactures, possesses with intent to [distribute](/usc/21/360eee.md?p=5), or [distributes](/usc/21/360eee.md?p=5) a [listed chemical](/usc/21/1907.md?p=4) in violation of [section 959 of this title](/usc/21/959.md).[^2] shall be fined in accordance with [title 18](/usc/18.md), imprisoned not more than 20 years in the case of a violation of paragraph [(1)](#d-1) or [(3)](#d-3) involving a list I chemical or not more than 10 years in the case of a violation of this subsection other than a violation of paragraph [(1)](#d-1) or [(3)](#d-3) involving a list I chemical, or both. # §960a. Foreign terrorist organizations, terrorist persons and groups - (a) **Prohibited acts—** Whoever engages in conduct that would be punishable under [section 841(a)](/usc/21/841.md?p=a)[^1] of this title if committed within the jurisdiction of the United States, or attempts or conspires to do so, knowing or intending to provide, directly or indirectly, [anything of pecuniary value](#d) to any [person](/usc/21/379j–21.md?p=k-10) or organization that has engaged or engages in terrorist activity (as defined in [section 1182(a)(3)(B) of title 8](/usc/8/1182.md?p=a-3-B)) or terrorism (as defined in [section 2656f(d)(2) of title 22](/usc/22/2656f.md?p=d-2)), shall be sentenced to a term of imprisonment of not less than twice the minimum punishment under section 841(b)(1),[^1] and not more than life, a fine in accordance with the provisions of [title 18](/usc/18.md), or both. Notwithstanding [section 3583 of title 18](/usc/18/3583.md), any sentence imposed under this subsection shall include a term of supervised release of at least 5 years in addition to such term of imprisonment. - (b) **Jurisdiction—** There is jurisdiction over an offense under this section if— - (1) the prohibited [drug](/usc/21/321.md?p=g-1) activity or the terrorist offense is in violation of the criminal laws of the United States; - (2) the offense, the prohibited [drug](/usc/21/321.md?p=g-1) activity, or the terrorist offense occurs in or affects interstate or foreign commerce; - (3) an offender provides [anything of pecuniary value](#d) for a terrorist offense that causes or is designed to cause death or serious bodily injury to a national of the United States while that national is outside the United States, or substantial damage to the property of a legal entity organized under the laws of the United States (including any of its [States](/usc/21/321.md?p=a-1), districts, commonwealths, [territories](/usc/21/387.md?p=19), or possessions) while that property is outside of the United States; - (4) the offense or the prohibited [drug](/usc/21/321.md?p=g-1) activity occurs in whole or in part outside of the United States (including on the high seas), and a perpetrator of the offense or the prohibited [drug](/usc/21/321.md?p=g-1) activity is a national of the United States or a legal entity organized under the laws of the United States (including any of its [States](/usc/21/321.md?p=a-1), districts, commonwealths, [territories](/usc/21/387.md?p=19), or possessions); or - (5) after the conduct required for the offense occurs an offender is brought into or found in the United States, even if the conduct required for the offense occurs outside the United States. - (c) **Proof requirements—** To violate [subsection (a)](#a), a [person](/usc/21/379j–21.md?p=k-10) must have knowledge that the [person](/usc/21/379j–21.md?p=k-10) or organization has engaged or engages in terrorist activity (as defined in [section 1182(a)(3)(B) of title 8](/usc/8/1182.md?p=a-3-B)) or terrorism (as defined in [section 2656f(d)(2) of title 22](/usc/22/2656f.md?p=d-2)). - (d) **Definition—** As used in this section, the term “anything of pecuniary value” has the meaning given the term in [section 1958(b)(1) of title 18](/usc/18/1958.md?p=b-1). # §961. Prohibited acts B Any [person](/usc/21/379j–21.md?p=k-10) who violates [section 954 of this title](/usc/21/954.md) or fails to notify the Attorney General of an importation or exportation under [section 971 of this title](/usc/21/971.md) shall be subject to the following penalties: - (1) Except as provided in [paragraph (2)](#2), any such [person](/usc/21/379j–21.md?p=k-10) shall, with respect to any such violation, be subject to a civil penalty of not more than $25,000. Sections [842(c)(1)](/usc/21/842.md?p=c-1) and [(c)(3)](/usc/21/842.md?p=c-3) of this title shall apply to any civil penalty assessed under this paragraph. - (2) If such a violation is prosecuted by an information or indictment which alleges that the violation was committed knowingly or intentionally and the trier of fact specifically finds that the violation was so committed, such [person](/usc/21/379j–21.md?p=k-10) shall be sentenced to imprisonment for not more than one year or a fine of not more than $25,000 or both. # §962. Second or subsequent offenses - (a) **Term of imprisonment and fine—** Any [person](/usc/21/379j–21.md?p=k-10) convicted of any offense under this subchapter is, if the offense is a second or subsequent offense, punishable by a term of imprisonment twice that otherwise [authorized](/usc/21/360eee–1.md?p=a-6), by twice the fine otherwise [authorized](/usc/21/360eee–1.md?p=a-6), or by both. If the conviction is for an offense punishable under [section 960(b) of this title](/usc/21/960.md?p=b), and if it is the offender’s second or subsequent offense, the court shall impose, in addition to any term of imprisonment and fine, twice the term of supervised release otherwise [authorized](/usc/21/360eee–1.md?p=a-6). - (b) **Determination of status—** For purposes of this section, a [person](/usc/21/379j–21.md?p=k-10) shall be considered convicted of a second or subsequent offense if, prior to the commission of such offense, one or more prior convictions of such [person](/usc/21/379j–21.md?p=k-10) for a felony [drug](/usc/21/321.md?p=g-1) offense have become final. - (c) **Procedures applicable—** [Section 851 of this title](/usc/21/851.md) shall apply with respect to any proceeding to sentence a [person](/usc/21/379j–21.md?p=k-10) under this section. # §963. Attempt and conspiracy Any [person](/usc/21/379j–21.md?p=k-10) who attempts or conspires to commit any offense defined in this subchapter shall be subject to the same penalties as those prescribed for the offense, the commission of which was the object of the attempt or conspiracy. # §964. Additional penalties Any penalty imposed for violation of this subchapter shall be in addition to, and not in lieu of, any civil or administrative penalty or sanction [authorized](/usc/21/360eee–1.md?p=a-6) by law. # §965. Applicability of part E of subchapter I Part E of subchapter I shall apply with respect to functions of the Attorney General (and of officers and employees of the Bureau of Narcotics and Dangerous [Drugs](/usc/21/321.md?p=g-1)) under this subchapter, to administrative and judicial proceedings under this subchapter, and to violations of this subchapter, to the same extent that such part applies to functions of the Attorney General (and such officers and employees) under subchapter I, to such proceedings under subchapter I, and to violations of subchapter I. For purposes of the application of this section to section [880](/usc/21/880.md) or [881](/usc/21/881.md) of this title, any reference in such section [880](/usc/21/880.md) or [881](/usc/21/881.md) of this title to “this subchapter” shall be deemed to be a reference to this subchapter, any reference to [section 823 of this title](/usc/21/823.md) shall be deemed to be a reference to [section 958 of this title](/usc/21/958.md), and any reference to [section 822(d) of this title](/usc/21/822.md?p=d) shall be deemed to be a reference to [section 957(b)(2) of this title](/usc/21/957.md?p=b-2). # §966. Authority of Secretary of the Treasury Nothing in this chapter shall derogate from the authority of the Secretary of the Treasury under the customs and related laws.