US Codex
Pub. L.
Notes

Title III — Fda and Controlled Substance Provisions

115th Congress · Approved Oct 24, 2018 · 132 Stat. 3894 · Lineage

TITLE III Fda and Controlled Substance Provisions

Subtitle A FDA Provisions

CHAPTER 1 In General

SEC. 3001. Clarifying Fda Regulation of Non-Addictive Pain Products.

(a)
Public Meetings.— Not later than one year after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the “Secretary”), acting through the Commissioner of Food and Drugs, shall hold not less than one public meeting to address the challenges and barriers of developing non-addictive medical products intended to treat acute or chronic pain or addiction, which may include—
(1)
the manner by which the Secretary may incorporate the risks of misuse and abuse of a controlled substance (as defined in section 102 of the Controlled Substances Act (21 U.S.C. 802)) into the risk benefit assessments under subsections (d) and (e) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), section 510(k) of such Act (21 U.S.C. 360(k)), or section 515(c) of such Act (21 U.S.C. 360e(c)), as applicable;
(2)
the application of novel clinical trial designs (consistent with section 3021 of the 21st Century Cures Act (Public Law 114–255)), use of real world evidence (consistent with section 505F of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355g)), and use of patient experience data (consistent with section 569C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–8c)) for the development of non-addictive medical products intended to treat pain or addiction;
(3)
the evidentiary standards and the development of opioid-sparing data for inclusion in the labeling of medical products intended to treat acute or chronic pain; and
(4)
the application of eligibility criteria under sections 506 and 515B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356, 360e–3) for non-addictive medical products intended to treat pain or addiction.
(b)
Guidance.— Not less than one year after the public meetings are conducted under subsection (a) the Secretary shall issue one or more final guidance documents, or update existing guidance documents, to help address challenges to developing non-addictive medical products to treat pain or addiction. Such guidance documents shall include information regarding—
(1)
how the Food and Drug Administration may apply sections 506 and 515B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356, 360e–3) to non-addictive medical products intended to treat pain or addiction, including the circumstances under which the Secretary—
(A)
may apply the eligibility criteria under such sections 506 and 515B to non-addictive medical products intended to treat pain or addiction;
(B)
considers the risk of addiction of controlled substances approved to treat pain when establishing unmet medical need; and
(C)
considers pain, pain control, or pain management in assessing whether a disease or condition is a serious or life-threatening disease or condition;
(2)
the methods by which sponsors may evaluate acute and chronic pain, endpoints for non-addictive medical products intended to treat pain, the manner in which endpoints and evaluations of efficacy will be applied across and within review divisions, taking into consideration the etiology of the underlying disease, and the manner in which sponsors may use surrogate endpoints, intermediate endpoints, and real world evidence;
(3)
the manner in which the Food and Drug Administration will assess evidence to support the inclusion of opioid-sparing data in the labeling of non-addictive medical products intended to treat acute or chronic pain, including—
(A)
alternative data collection methodologies, including the use of novel clinical trial designs (consistent with section 3021 of the 21st Century Cures Act (Public Law 114–255)) and real world evidence (consistent with section 505F of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355g)), including patient registries and patient reported outcomes, as appropriate, to support product labeling;
(B)
ethical considerations of exposing subjects to controlled substances in clinical trials to develop opioid-sparing data and considerations on data collection methods that reduce harm, which may include the reduction of opioid use as a clinical benefit;
(C)
endpoints, including primary, secondary, and surrogate endpoints, to evaluate the reduction of opioid use;
(D)
best practices for communication between sponsors and the agency on the development of data collection methods, including the initiation of data collection; and
(E)
the appropriate format in which to submit such data results to the Secretary; and
(4)
the circumstances under which the Food and Drug Administration considers misuse and abuse of a controlled substance (as defined in section 102 of the Controlled Substances Act (21 U.S.C. 802)) in making the risk benefit assessment under paragraphs (2) and (4) of subsection (d) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) and in finding that a drug is unsafe under paragraph (1) or (2) of subsection (e) of such section.
(c)
Definitions.— In this section—
(1)
the term “medical product” means a drug (as defined in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)(1))), biological product (as defined in section 351(i) of the Public Health Service Act (42 U.S.C. 262(i))), or device (as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(h))); and
(2)
the term “opioid-sparing” means reducing, replacing, or avoiding the use of opioids or other controlled substances intended to treat acute or chronic pain.

SEC. 3002. Evidence-Based Opioid Analgesic Prescribing Guidelines and Report.

(a)
Guidelines.— The Commissioner of Food and Drugs shall develop evidence-based opioid analgesic prescribing guidelines for the indication-specific treatment of acute pain only for the relevant therapeutic areas where such guidelines do not exist.
(b)
Public Input.— In developing the guidelines under subsection (a), the Commissioner of Food and Drugs shall—
(1)
consult with stakeholders, which may include conducting a public meeting of medical professional societies (including any State-based societies), health care providers, State medical boards, medical specialties including pain medicine specialty societies, patient groups, pharmacists, academic or medical research entities, and other entities with experience in health care, as appropriate;
(2)
collaborate with the Director of the Centers for Disease Control and Prevention, as applicable and appropriate, and other Federal agencies with relevant expertise as appropriate; and
(3)
provide for a notice and comment period consistent with section 701(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371(h)) for the submission of comments by the public.
(c)
Report.— Not later than 1 year after the date of enactment of this Act, or, if earlier, at the time the guidelines under subsection (a) are finalized, the Commissioner of Food and Drugs shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate, and post on the public website of the Food and Drug Administration, a report on how the Food and Drug Administration will utilize the guidelines under subsection (a) to protect the public health and a description of the public health need with respect to each such indication-specific treatment guideline.
(d)
Updates.— The Commissioner of Food and Drugs shall periodically—
(1)
update the guidelines under subsection (a), informed by public input described in subsection (b); and
(2)
submit to the committees specified in subsection (c) and post on the public website of the Food and Drug Administration an updated report under such subsection.
(e)
Statement To Accompany Guidelines and Recommendations.— The Commissioner of Food and Drugs shall ensure that opioid analgesic prescribing guidelines and other recommendations developed under this section are accompanied by a clear statement that such guidelines or recommendations, as applicable—
(1)
are intended to help inform clinical decisionmaking by prescribers and patients; and
(2)
are not intended to be used for the purposes of restricting, limiting, delaying, or denying coverage for, or access to, a prescription issued for a legitimate medical purpose by an individual practitioner acting in the usual course of professional practice.

CHAPTER 2 Stop Counterfeit Drugs by Regulating and Enhancing Enforcement Now

SEC. 3011. Short Title.

This chapter may be cited as the “Stop Counterfeit Drugs by Regulating and Enhancing Enforcement Now Act” or the “SCREEN Act”.

SEC. 3012. Notification, Nondistribution, and Recall of Controlled Substances.

(a)
Prohibited Acts.— Section 301 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amended by adding at the end the following:

“(eee) The failure to comply with any order issued under section 569D.”

(b)
Notification, Nondistribution, and Recall of Controlled Substances.— Subchapter E of chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb et seq.) is amended by adding at the end the following:

“SEC. 569D. NOTIFICATION, NONDISTRIBUTION, AND RECALL OF CONTROLLED SUBSTANCES.

“(a) Order To Cease Distribution and Recall.—

“(1) In general.—If the Secretary determines there is a reasonable probability that a controlled substance would cause serious adverse health consequences or death, the Secretary may, after providing the appropriate person with an opportunity to consult with the agency, issue an order requiring manufacturers, importers, distributors, or pharmacists, who distribute such controlled substance to immediately cease distribution of such controlled substance.

“(2) Hearing.—An order under paragraph (1) shall provide the person subject to the order with an opportunity for an informal hearing, to be held not later than 10 days after the date of issuance of the order, on whether adequate evidence exists to justify an amendment to the order, and what actions are required by such amended order pursuant to subparagraph (3).

“(3) Order resolution.—After an order is issued according to the process under paragraphs (1) and (2), the Secretary shall, except as provided in paragraph (4)—

“(A) vacate the order, if the Secretary determines that inadequate grounds exist to support the actions required by the order;

“(B) continue the order ceasing distribution of the controlled substance until a date specified in such order; or

“(C) amend the order to require a recall of the controlled substance, including any requirements to notify appropriate persons, a timetable for the recall to occur, and a schedule for updates to be provided to the Secretary regarding such recall.

“(4) Risk assessment.—If the Secretary determines that the risk of recalling a controlled substance presents a greater health risk than the health risk of not recalling such controlled substance from use, an amended order under subparagraph (B) or (C) of paragraph (3) shall not include either a recall order for, or an order to cease distribution of, such controlled substance, as applicable.

“(5) Action following order.—Any person who is subject to an order pursuant to subparagraph (B) or (C) of paragraph (3) shall immediately cease distribution of or recall, as applicable, the controlled substance and provide notification as required by such order.

“(b) Notice to Persons Affected.—If the Secretary determines necessary, the Secretary may require the person subject to an order pursuant to paragraph (1) or an amended order pursuant to subparagraph (B) or (C) of paragraph (3) to provide either a notice of a recall order for, or an order to cease distribution of, such controlled substance, as applicable, under this section to appropriate persons, including persons who manufacture, distribute, import, or offer for sale such product that is the subject of an order and to the public. In providing such notice, the Secretary may use the assistance of health professionals who prescribed or dispensed such controlled substances.

“(c) Nondelegation.—An order described in subsection (a)(3) shall be ordered by the Secretary or an official designated by the Secretary. An official may not be so designated under this section unless the official is the Director of the Center for Drug Evaluation and Research or an official senior to such Director.

“(d) Savings Clause.—Nothing contained in this section shall be construed as limiting—

“(1) the authority of the Secretary to issue an order to cease distribution of, or to recall, any drug under any other provision of this Act or the Public Health Service Act; or

“(2) the ability of the Secretary to request any person to perform a voluntary activity related to any drug subject to this Act or the Public Health Service Act.”

(c)
Controlled Substances Subject to Refusal.— The third sentence of section 801(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381(a)) is amended by inserting “ , or is a controlled substance subject to an order under section 569D” before “ , or (4)”.
(d)
Effective Date.— Sections 301(eee) and 569D of the Federal Food, Drug, and Cosmetic Act, as added by subsections (a) and (b), shall be effective beginning on the date of enactment of this Act.

SEC. 3013. Single Source Pattern of Imported Illegal Drugs.

Section 801 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381), as amended by section 3012, is further amended by adding at the end the following:

“(t) Single Source Pattern of Imported Illegal Drugs.—If the Secretary determines that a person subject to debarment as a result of engaging in a pattern of importing or offering for import controlled substances or drugs as described in section 306(b)(3)(D), and such pattern is identified by the Secretary as being offered for import from the same manufacturer, distributor, or importer, the Secretary may by order determine all drugs being offered for import from such person as adulterated or misbranded, unless such person can provide evidence otherwise.”

SEC. 3014. Strengthening Fda and Cbp Coordination and Capacity.

(a)
In General.— The Secretary of Health and Human Services (referred to in this section as the “Secretary”), acting through the Commissioner of Food and Drugs, shall coordinate with the Secretary of Homeland Security to carry out activities related to customs and border protection and in response to illegal controlled substances and drug imports, including at sites of import (such as international mail facilities), that will provide improvements to such facilities, technologies, and inspection capacity. Such Secretaries may carry out such activities through a memorandum of understanding between the Food and Drug Administration and the U.S. Customs and Border Protection.
(b)
FDA Import Facilities and Inspection Capacity.—
(1)
In general.— In carrying out this section, the Secretary shall, in collaboration with the Secretary of Homeland Security and the Postmaster General of the United States Postal Service, provide that import facilities in which the Food and Drug Administration operates or carries out activities related to drug imports within the international mail facilities include—
(A)
facility upgrades and improved capacity in order to increase and improve inspection and detection capabilities, which may include, as the Secretary determines appropriate—
(i)
improvements to facilities, such as upgrades or renovations, and support for the maintenance of existing import facilities and sites to improve coordination between Federal agencies;
(ii)
improvements in equipment and information technology enhancement to identify unapproved, counterfeit, or other unlawful controlled substances for destruction;
(iii)
the construction of, or upgrades to, laboratory capacity for purposes of detection and testing of imported goods;
(iv)
upgrades to the security of import facilities; and
(v)
innovative technology and equipment to facilitate improved and near-real-time information sharing between the Food and Drug Administration, the Department of Homeland Security, and the United States Postal Service; and
(B)
innovative technology, including controlled substance detection and testing equipment and other applicable technology, in order to collaborate with the U.S. Customs and Border Protection to share near-real-time information, including information about test results, as appropriate.
(2)
Innovative technology.— Any technology used in accordance with paragraph (1)(B) shall be interoperable with technology used by other relevant Federal agencies, including the U.S. Customs and Border Protection, as the Secretary determines appropriate and practicable.
(c)
Report.— Not later than 6 months after the date of enactment of this Act, the Secretary, in consultation with the Secretary of Homeland Security and the Postmaster General of the United States Postal Service, shall report to the Committee on Energy and Commerce and the Committee on Homeland Security of the House of Representatives and the Committee on Health, Education, Labor, and Pensions and the Committee on Homeland Security and Governmental Affairs of the Senate on the implementation of this section, including a summary of progress made toward near-real-time information sharing and the interoperability of such technologies.

CHAPTER 3 Stop Illicit Drug Importation

SEC. 3021. Short Title.

This chapter may be cited as the “Stop Illicit Drug Importation Act of 2018”.

SEC. 3022. Restricting Entrance of Illicit Drugs.

(a)
Food and Drug Administration and U.S. Customs and Border Protection Cooperation.—
(1)
In general.— The Secretary of Health and Human Services (referred to in this section as the “Secretary”), acting through the Commissioner of Food and Drugs and in consultation with the U.S. Customs and Border Protection, shall develop and periodically update a mutually agreed upon list of the controlled substances that the Secretary will refer to U.S. Customs and Border Protection, unless the Secretary and U.S. Customs and Border Protection agree otherwise, when such substances are offered for import via international mail and appear to violate the Controlled Substances Act (21 U.S.C. 801 et seq.), the Controlled Substances Import and Export Act (21 U.S.C. 951 et seq.), the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), or any other applicable law. The Secretary shall transfer controlled substances on such list to the U.S. Customs and Border Protection. If the Secretary identifies additional packages that appear to be the same as such package containing a controlled substance, such additional packages may also be transferred to U.S. Customs and Border Protection. The U.S. Customs and Border Protection shall receive such packages consistent with the requirements of the Controlled Substances Act (21 U.S.C. 801 et seq.).
(2)
Report.— Not later than 9 months after the date of enactment of this Act, the Secretary, acting through the Commissioner of Food and Drugs and in consultation with the Secretary of Homeland Security, shall report to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate on the implementation of this section.
(b)
Debarment, Temporary Denial of Approval, and Suspension.—
(1)
Prohibited act.— Section 301(cc) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(cc)) is amended—
(A)
by inserting “ or a drug” after “ food”; and
(B)
by inserting “ from such activity” after “ person debarred”.
(2)
Debarment.— Section 306(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 335a(b)) is amended—
(A)
in paragraph (1)—
(i)
in the matter preceding subparagraph (A), by inserting “ or (3)” after “ paragraph (2)”;
(ii)
in subparagraph (A), by striking the comma at the end and inserting a semicolon;
(iii)
in subparagraph (B), by striking “ , or” and inserting a semicolon;
(iv)
in subparagraph (C), by striking the period and inserting “ ; or”; and
(v)
by adding at the end the following:

“(D) a person from importing or offering for import into the United States a drug.”

(B)
in paragraph (3)—
(i)
in the heading, by inserting “ or drug” after “ Food”;
(ii)
in subparagraph (A), by striking “ ; or” and inserting a semicolon;
(iii)
in subparagraph (B), by striking the period and inserting a semicolon; and
(iv)
by adding at the end the following:

“(C) the person has been convicted of a felony for conduct relating to the importation into the United States of any drug or controlled substance (as defined in section 102 of the Controlled Substances Act);

“(D) the person has engaged in a pattern of importing or offering for import—

“(i) controlled substances that are prohibited from importation under section 401(m) of the Tariff Act of 1930 (19 U.S.C. 1401(m)); or

“(ii) adulterated or misbranded drugs that are—

“(I) not designated in an authorized electronic data interchange system as a product that is regulated by the Secretary; or

“(II) knowingly or intentionally falsely designated in an authorized electronic data interchange system as a product that is regulated by the Secretary.”

; and

(C)
by adding at the end the following:

“(5) Definition.—For purposes of paragraph (3)(D), the term ‘pattern of importing or offering for import’ means importing or offering for import a drug described in clause (i) or (ii) of paragraph (3)(D) in an amount, frequency, or dosage that is inconsistent with personal or household use by the importer.”

(c)
Imports and Exports.— Section 801(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381(a)), as amended, is further amended—
(1)
by striking “ , then such article shall be refused admission” inserting “ or (5) such article is being imported or offered for import in violation of section 301(cc), then any such article described in any of clauses (1) through (5) shall be refused admission”;
(2)
by inserting “ If it appears from the examination of such samples or otherwise that the article is a counterfeit drug, such article shall be refused admission.” before “ With respect to an article of food, if importation”; and
(3)
by striking “ Clause (2) of the third sentence” and all that follows through the period at the end and inserting the following: “ Neither clause (2) nor clause (5) of the third sentence of this subsection shall be construed to prohibit the admission of narcotic drugs, the importation of which is permitted under the Controlled Substances Import and Export Act.”.
(d)
Certain Illicit Articles.— Section 801 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381), as amended, is amended by adding at the end the following—

“(u) Illicit Articles Containing Active Pharmaceutical Ingredients.—

“(1) In general.—For purposes of this section, an article that is being imported or offered for import into the United States may be treated by the Secretary as a drug if the article—

“(A) is not—

“(i) accompanied by an electronic import entry for such article submitted using an authorized electronic data interchange system; and

“(ii) designated in such a system as an article regulated by the Secretary (which may include regulation as a drug, a device, a dietary supplement, or other product that is regulated under this Act); and

“(B) is an ingredient that presents significant public health concern and is, or contains—

“(i) an active ingredient in a drug—

“(I) that is approved under section 505 or licensed under section 351 of the Public Health Service Act; or

“(II) for which—

“(aa) an investigational use exemption has been authorized under section 505(i) of this Act or section 351(a) of the Public Health Service Act; and

“(bb) a substantial clinical investigation has been instituted, and such investigation has been made public; or

“(ii) a substance that has a chemical structure that is substantially similar to the chemical structure of an active ingredient in a drug or biological product described in subclause (I) or (II) of clause (i).

“(2) Effect.—This subsection shall not be construed to bear upon any determination of whether an article is a drug within the meaning of section 201(g), other than for the purposes described in paragraph (1).”

CHAPTER 4 Securing Opioids and Unused Narcotics with Deliberate Disposal and Packaging

SEC. 3031. Short Title.

This chapter may be cited as the “Securing Opioids and Unused Narcotics with Deliberate Disposal and Packaging Act of 2018” or the “SOUND Disposal and Packaging Act”.

SEC. 3032. Safety-Enhancing Packaging and Disposal Features.

(a)
Deliberate Disposal and Packaging Elements of Strategy.— Section 505–1(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355–1(e)) is amended by adding at the end the following:

“(4) Packaging and disposal.—The Secretary may require a risk evaluation mitigation strategy for a drug for which there is a serious risk of an adverse drug experience described in subparagraph (B) or (C) of subsection (b)(1), taking into consideration the factors described in subparagraphs (C) and (D) of subsection (f)(2) and in consultation with other relevant Federal agencies with authorities over drug disposal packaging, which may include requiring that—

“(A) the drug be made available for dispensing to certain patients in unit dose packaging, packaging that provides a set duration, or another packaging system that the Secretary determines may mitigate such serious risk; or

“(B) the drug be dispensed to certain patients with a safe disposal packaging or safe disposal system for purposes of rendering drugs nonretrievable (as defined in section 1300.05 of title 21, Code of Federal Regulations (or any successor regulation)) if the Secretary determines that such safe disposal packaging or system may mitigate such serious risk and is sufficiently available.”

(b)
Assuring Access and Minimizing Burden.— Section 505–1(f)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355–1(f)(2)(C)) is amended—
(1)
in clause (i) by striking “ and” at the end; and
(2)
by adding at the end the following:

“(iii) patients with functional limitations; and”

(c)
Application to Abbreviated New Drug Applications.— Section 505–1(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355–1(i)) is amended—
(1)
in paragraph (1)—
(A)
by redesignating subparagraph (B) as subparagraph (C); and
(B)
inserting after subparagraph (A) the following:

“(B) A packaging or disposal requirement, if required under subsection (e)(4) for the applicable listed drug.”

; and

(2)
in paragraph (2)—
(A)
in subparagraph (A), by striking “ and” at the end;
(B)
by redesignating subparagraph (B) as subparagraph (C); and
(C)
by inserting after subparagraph (A) the following:

“(B) shall permit packaging systems and safe disposal packaging or safe disposal systems that are different from those required for the applicable listed drug under subsection (e)(4); and”

(d)
GAO Report.— Not later than 12 months after the date of enactment of this Act, the Comptroller General of the United States shall prepare and submit to Congress a report containing—
(1)
a description of available evidence, if any, on the effectiveness of site-of-use, in-home controlled substance disposal products and packaging technologies;
(2)
an evaluation of existing reference standards with respect to controlled substance disposal products and packaging technologies, including any such standards established by a standards development organization, and how such standards should be considered in ensuring effectiveness of such products and technologies;
(3)
identification of ways in which such disposal products intended for use by patients, consumers, and other end users that are not registrants under the Controlled Substances Act (21 U.S.C. 801 et seq.), are made available to the public and any barriers to the use of such disposal products;
(4)
identification of ways in which packaging technologies are made available to the public and any barriers to the use of such technologies;
(5)
a description of current Federal oversight, if any, of site-of-use, in-home controlled substance disposal products, including—
(A)
identification of the Federal agencies that oversee such products;
(B)
identification of the methods of disposal of controlled substances recommended by such agencies for site-of-use, in-home disposal; and
(C)
a description of the effectiveness of such recommendations at preventing the diversion of legally prescribed controlled substances;
(6)
a description of current Federal oversight, if any, of controlled substance packaging technologies, including—
(A)
identification of the Federal agencies that oversee such technologies;
(B)
identification of the technologies recommended by such agencies, including unit dose packaging, packaging that provides a set duration, and other packaging systems that may mitigate abuse or misuse; and
(C)
a description of the effectiveness of such recommendations at preventing the diversion of legally prescribed controlled substances; and
(7)
recommendations, as appropriate, on—
(A)
whether site-of-use, in-home controlled substance disposal products and packaging technologies require Federal oversight and, if so, which agency or agencies should be responsible for such oversight and, as applicable, review of such products or technologies; and
(B)
whether there are applicable standards that should be considered to ensure the effectiveness of such products.

CHAPTER 5 Postapproval Study Requirements

SEC. 3041. Clarifying Fda Postmarket Authorities.

(a)
Definition of Adverse Drug Experience.— Section 505–1(b)(1)(E) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355–1(b)(1)(E)) is amended by striking “ of the drug” and inserting “ of the drug, which may include reduced effectiveness under the conditions of use prescribed in the labeling of such drug, but which may not include reduced effectiveness that is in accordance with such labeling”.
(b)
Safety Labeling Changes.— Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(o)(4)) is amended—
(1)
in subparagraph (A) by—
(A)
striking “ Safety information” and inserting “ Safety or new effectiveness information”; and
(B)
by striking “ If the Secretary becomes” and all that follows through “ in the labeling of the drug” and inserting “ If the Secretary becomes aware of new information, including any new safety information or information related to reduced effectiveness, that the Secretary determines should be included in the labeling of the drug”;
(2)
in clause (i) of subparagraph (B), by inserting before the semicolon “ , or new effectiveness information”;
(3)
in subparagraph (C) by striking “ safety information” and inserting “ safety or new effectiveness information”; and
(4)
in subparagraph (E) by striking “ safety information” and inserting “ safety or new effectiveness information”.
(c)
Guidance.— Not less than one year after the date of enactment of this Act, the Secretary of Health and Human Services shall issue guidance regarding the circumstances under which the Food and Drug Administration may require postmarket studies or clinical trials to assess the potential reduction in effectiveness of a drug and how such reduction in effectiveness could result in a change to the benefits of the drug and the risks to the patient. Such guidance shall also address how the Food and Drug Administration may apply this section and the amendments made thereby with respect to circumstances under which the Food and Drug Administration may require postmarket studies or clinical trials and safety labeling changes related to the use of controlled substances for acute or chronic pain.

Subtitle B Controlled Substance Provisions

CHAPTER 1 More Flexibility with Respect to Medication-Assisted Treatment for Opioid Use Disorders

SEC. 3201. Allowing for More Flexibility with Respect to Medication-Assisted Treatment for Opioid Use Disorders.

(a)
Conforming Applicable Number.— Subclause (II) of section 303(g)(2)(B)(iii) of the Controlled Substances Act (21 U.S.C. 823(g)(2)(B)(iii)) is amended to read as follows:

“(II) The applicable number is—

“(aa) 100 if, not sooner than 1 year after the date on which the practitioner submitted the initial notification, the practitioner submits a second notification to the Secretary of the need and intent of the practitioner to treat up to 100 patients;

“(bb) 100 if the practitioner holds additional credentialing, as defined in section 8.2 of title 42, Code of Federal Regulations (or successor regulations);

“(cc) 100 if the practitioner provides medication-assisted treatment (MAT) using covered medications (as such terms are defined in section 8.2 of title 42, Code of Federal Regulations (or successor regulations)) in a qualified practice setting (as described in section 8.615 of title 42, Code of Federal Regulations (or successor regulations)); or

“(dd) 275 if the practitioner meets the requirements specified in sections 8.610 through 8.655 of title 42, Code of Federal Regulations (or successor regulations).”

(b)
Eliminating Any Time Limitation for Nurse Practitioners and Physician Assistants To Become Qualifying Practitioners.— Clause (iii) of section 303(g)(2)(G) of the Controlled Substances Act (21 U.S.C. 823(g)(2)(G)) is amended—
(1)
in subclause (I), by striking “ or” at the end; and
(2)
by amending subclause (II) to read as follows:

“(II) a qualifying other practitioner, as defined in clause (iv), who is a nurse practitioner or physician assistant; or”

(c)
Imposing a Time Limitation for Clinical Nurse Specialists, Certified Registered Nurse Anesthetists, and Certified Nurse Midwifes To Become Qualifying Practitioners.— Clause (iii) of section 303(g)(2)(G) of the Controlled Substances Act (21 U.S.C. 823(g)(2)(G)), as amended by subsection (b), is further amended by adding at the end the following:

“(III) for the period beginning on October 1, 2018, and ending on October 1, 2023, a qualifying other practitioner, as defined in clause (iv), who is a clinical nurse specialist, certified registered nurse anesthetist, or certified nurse midwife.”

(d)
Definition of Qualifying Other Practitioner.— Section 303(g)(2)(G)(iv) of the Controlled Substances Act (21 U.S.C. 823(g)(2)(G)(iv)) is amended by striking “ nurse practitioner or physician assistant” each place it appears and inserting “ nurse practitioner, clinical nurse specialist, certified registered nurse anesthetist, certified nurse midwife, or physician assistant”.
(e)
Report by Secretary.— Not later than 2 years after the date of the enactment of this Act, the Secretary of Health and Human Services, in consultation with the Drug Enforcement Administration, shall submit to Congress a report that assesses the care provided by qualifying practitioners (as defined in section 303(g)(2)(G)(iii) of the Controlled Substances Act (21 U.S.C. 823(g)(2)(G)(iii))) who are treating, in the case of physicians, more than 100 patients, and in the case of qualifying practitioners who are not physicians, more than 30 patients. Such report shall include recommendations on future applicable patient number levels and limits. In preparing such report, the Secretary shall study, with respect to opioid use disorder treatment—
(1)
the average frequency with which qualifying practitioners see their patients;
(2)
the average frequency with which patients receive counseling, including the rates by which such counseling is provided by such a qualifying practitioner directly, or by referral;
(3)
the frequency of toxicology testing, including the average frequency with which random toxicology testing is administered;
(4)
the average monthly patient caseload for each type of qualifying practitioner;
(5)
the treatment retention rates for patients;
(6)
overdose and mortality rates; and
(7)
any available information regarding the diversion of drugs by patients receiving such treatment from such a qualifying practitioner.

SEC. 3202. Medication-Assisted Treatment for Recovery from Substance Use Disorder.

(a)
Waivers for Maintenance Treatment or Detoxification.— Section 303(g)(2)(G)(ii) of the Controlled Substances Act (21 U.S.C. 823(g)(2)(G)(ii)) is amended by adding at the end the following:

“(VIII) The physician graduated in good standing from an accredited school of allopathic medicine or osteopathic medicine in the United States during the 5-year period immediately preceding the date on which the physician submits to the Secretary a written notification under subparagraph (B) and successfully completed a comprehensive allopathic or osteopathic medicine curriculum or accredited medical residency that—

“(aa) included not less than 8 hours of training on treating and managing opioid-dependent patients; and

“(bb) included, at a minimum—

“(AA) the training described in items (aa) through (gg) of subclause (IV); and

“(BB) training with respect to any other best practice the Secretary determines should be included in the curriculum, which may include training on pain management, including assessment and appropriate use of opioid and non-opioid alternatives.”

(b)
Treatment for Children.— The Secretary of Health and Human Services shall consider ways to ensure that an adequate number of qualified practitioners, as defined in subparagraph (G)(ii) of section 303(g)(2) of the Controlled Substances Act (21 U.S.C. 823(g)(2)), who have a specialty in pediatrics or the treatment of children or adolescents, are granted a waiver under such section 303(g)(2) to treat children and adolescents with substance use disorders.
(c)
Technical Amendment.— Section 102(24) of the Controlled Substances Act (21 U.S.C. 802(24)) is amended by striking “ Health, Education, and Welfare” and inserting “ Health and Human Services”.

SEC. 3203. Grants to Enhance Access to Substance Use Disorder Treatment.

(a)
In General.— The Secretary of Health and Human Services shall establish a grant program under which the Secretary may make grants to accredited schools of allopathic medicine or osteopathic medicine and teaching hospitals located in the United States to support the development of curricula that meet the requirements under subclause (VIII) of section 303(g)(2)(G)(ii) of the Controlled Substances Act, as added by section 3202(a) of this Act.
(b)
Authorization of Appropriations.— There is authorized to be appropriated, for grants under subsection (a), $4,000,000 for each of fiscal years 2019 through 2023.

SEC. 3204. Delivery of a Controlled Substance by a Pharmacy to Be Administered by Injection or Implantation.

(a)
In General.— The Controlled Substances Act is amended by inserting after section 309 (21 U.S.C. 829) the following:

“Sec. 309 “delivery of a controlled substance by a pharmacy to an administering practitioner

A.

(a) In General.—Notwithstanding section 102(10), a pharmacy may deliver a controlled substance to a practitioner in accordance with a prescription that meets the requirements of this title and the regulations issued by the Attorney General under this title, for the purpose of administering the controlled substance by the practitioner if—

“(1) the controlled substance is delivered by the pharmacy to the prescribing practitioner or the practitioner administering the controlled substance, as applicable, at the location listed on the practitioner’s certificate of registration issued under this title;

“(2) the controlled substance is to be administered for the purpose of maintenance or detoxification treatment under section 303(g)(2) and—

“(A) the practitioner who issued the prescription is a qualifying practitioner authorized under, and acting within the scope of that section; and

“(B) the controlled substance is to be administered by injection or implantation;

“(3) the pharmacy and the practitioner are authorized to conduct the activities specified in this section under the law of the State in which such activities take place;

“(4) the prescription is not issued to supply any practitioner with a stock of controlled substances for the purpose of general dispensing to patients;

“(5) except as provided in subsection (b), the controlled substance is to be administered only to the patient named on the prescription not later than 14 days after the date of receipt of the controlled substance by the practitioner; and

“(6) notwithstanding any exceptions under section 307, the prescribing practitioner, and the practitioner administering the controlled substance, as applicable, maintain complete and accurate records of all controlled substances delivered, received, administered, or otherwise disposed of under this section, including the persons to whom controlled substances 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 the date of enactment of this section, the Attorney General, in coordination with the Secretary, may reduce the number of days described in subsection (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, may modify the number of days described in subsection (a)(5).

“(3) Minimum number of days.—Any modification under this subsection shall be for a period of not less than 7 days.”

(b)
Study and Report.— Not later than 2 years after the date of enactment of this section, the Comptroller General of the United States shall conduct a study and submit to Congress a report on access to and potential diversion of controlled substances administered by injection or implantation.
(c)
Technical and Conforming Amendment.— The table of contents for the Comprehensive Drug Abuse Prevention and Control Act of 1970 is amended by inserting after the item relating to section 309 the following:

“Sec. 309A. Delivery of a controlled substance by a pharmacy to an administering practitioner.”.

CHAPTER 2 Empowering Pharmacists in the Fight Against Opioid Abuse

SEC. 3211. Short Title.

This chapter may be cited as the “Empowering Pharmacists in the Fight Against Opioid Abuse Act”.

SEC. 3212. Programs and Materials for Training on Certain Circumstances under Which a Pharmacist May Decline to Fill a Prescription.

(a)
In General.— Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services, in consultation with the Administrator of the Drug Enforcement Administration, Commissioner of Food and Drugs, Director of the Centers for Disease Control and Prevention, and Assistant Secretary for Mental Health and Substance Use, shall develop and disseminate, as appropriate, materials for pharmacists, health care providers, and patients on—
(1)
circumstances under which a pharmacist may, consistent with section 309 of the Controlled Substances Act (21 U.S.C. 829) and regulations thereunder, including section 1306.04 of title 21, Code of Federal Regulations, decline to fill a prescription for a controlled substance because the pharmacist suspects the prescription is fraudulent, forged, or of doubtful, questionable, or suspicious origin; and
(2)
other Federal requirements pertaining to declining to fill a prescription under such circumstances, including the partial fill of prescriptions for certain controlled substances.
(b)
Materials Included.— In developing materials under subsection (a), the Secretary of Health and Human Services shall include information for—
(1)
pharmacists on how to decline to fill a prescription and actions to take after declining to fill a prescription; and
(2)
other health care practitioners and the public on a pharmacist’s ability to decline to fill prescriptions in certain circumstances and a description of those circumstances (as described in the materials developed under subsection (a)(1)).
(c)
Stakeholder Input.— In developing the programs and materials required under subsection (a), the Secretary of Health and Human Services shall seek input from relevant national, State, and local associations, boards of pharmacy, medical societies, licensing boards, health care practitioners, and patients, including individuals with chronic pain.

CHAPTER 3 Safe Disposal of Unused Medication

SEC. 3221. Short Title.

This chapter may be cited as the “Safe Disposal of Unused Medication Act”.

SEC. 3222. Disposal of Controlled Substances of a Hospice Patient by Employees of a Qualified Hospice Program.

(a)
In General.— Subsection (g) of section 302 of the Controlled Substances Act (21 U.S.C. 822) is amended by adding at the end the following:

“(5)

(A) In the case of a person receiving hospice care, an employee of a qualified hospice program, acting within the scope of employment, may handle, without being registered under this section, any controlled substance that was lawfully dispensed to the person receiving hospice care, for the purpose of disposal of the controlled substance so long as such disposal occurs onsite in accordance with all applicable Federal, State, Tribal, and local law and—

“(i) the disposal occurs after the death of a person receiving hospice care;

“(ii) the controlled substance is expired; or

“(iii)

(I) the employee is—

“(aa) the physician of the person receiving hospice care; and

“(bb) registered under section 303(f); and

“(II) the hospice patient no longer requires the controlled substance 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 1861(dd) of the Social Security Act.

“(ii) The term ‘employee of a qualified hospice program’ means a physician, physician assistant, nurse, or other person who—

“(I) is employed by, or pursuant to arrangements made by, a qualified hospice program;

“(II)

(aa) is licensed to perform medical or nursing services by the jurisdiction in which the person receiving hospice care was located; and

“(bb) is acting within the scope of such employment in accordance with applicable State law; and

“(III) has completed training through the qualified hospice program regarding the disposal of controlled substances in a secure and responsible manner so as to discourage abuse, misuse, or diversion.

“(iii) The term ‘qualified hospice program’ means a hospice program that—

“(I) has written policies and procedures for assisting in the disposal of the controlled substances of a person receiving hospice care after the person’s death;

“(II) at the time when the controlled substances 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; 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—

“(aa) documents in the patient’s clinical record the type of controlled substance, dosage, route of administration, and quantity so disposed; and

“(bb) the time, date, and manner in which that disposal occurred.”

(b)
Guidance.— The Attorney General may issue guidance to hospice programs (as defined in paragraph (5) of section 302(g) of the Controlled Substances Act (21 U.S.C. 822(g)), as added by subsection (a)) to assist the programs in satisfying the requirements under such paragraph (5).
(c)
Rule of Construction Relating to State and Local Law.— Nothing in this section or the amendments made by this section shall be construed to prevent a State or local government from imposing additional controls or restrictions relating to the regulation of the disposal of controlled substances in hospice care or hospice programs.

SEC. 3223. Gao Study and Report on Hospice Safe Drug Management.

(a)
Study.—
(1)
In general.— The Comptroller General of the United States (in this section referred to as the “Comptroller General”) shall conduct a study on the requirements applicable to, and challenges of, hospice programs with regard to the management and disposal of controlled substances in the home of an individual.
(2)
Contents.— In conducting the study under paragraph (1), the Comptroller General shall include—
(A)
an overview of any challenges encountered by selected hospice programs regarding the disposal of controlled substances, such as opioids, in a home setting, including any key changes in policies, procedures, or best practices for the disposal of controlled substances over time; and
(B)
a description of Federal requirements, including requirements under the Medicare program, for hospice programs regarding the disposal of controlled substances in a home setting, and oversight of compliance with those requirements.
(b)
Report.— Not later than 18 months after the date of enactment of this Act, the Comptroller General shall submit to Congress a report containing the results of the study conducted under subsection (a), together with recommendations, if any, for such legislation and administrative action as the Comptroller General determines appropriate.

CHAPTER 4 Special Registration for Telemedicine Clarification

SEC. 3231. Short Title.

This chapter may be cited as the “Special Registration for Telemedicine Clarification Act of 2018”.

SEC. 3232. Regulations Relating to a Special Registration for Telemedicine.

Section 311(h)(2) of the Controlled Substances Act (21 U.S.C. 831(h)(2)) is amended to read as follows:

“(2) Regulations.—Not later than 1 year after the date of enactment of the SUPPORT for Patients and Communities Act, in consultation with the Secretary, 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.”

CHAPTER 5 Synthetic Abuse and Labeling of Toxic Substances

SEC. 3241. Controlled Substance Analogues.

Section 203 of the Controlled Substances Act (21 U.S.C. 813) is amended—
(1)
by striking “ A controlled” and inserting “ (a) In General.—A controlled”; and
(2)
by adding at the end the following:

“(b) Determination.—In determining whether a controlled substance analogue was intended for human consumption under subsection (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, or distribution 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 that is manufactured, formulated, sold, distributed, or marketed with the intent to avoid the provisions of existing drug 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.”

CHAPTER 6 Access to Increased Drug Disposal

SEC. 3251. Short Title.

This chapter may be cited as the “Access to Increased Drug Disposal Act of 2018”.

SEC. 3252. Definitions.

In this chapter—
(1)
the term “Attorney General” means the Attorney General, acting through the Assistant Attorney General for the Office of Justice Programs;
(2)
the term “authorized collector” means a narcotic treatment program, a hospital or clinic with an on-site pharmacy, a retail pharmacy, or a reverse distributor, that is authorized as a collector under section 1317.40 of title 21, Code of Federal Regulations (or any successor regulation);
(3)
the term “covered grant” means a grant awarded under section 3003; and
(4)
the term “eligible collector” means a person who is eligible to be an authorized collector.

SEC. 3253. Authority to Make Grants.

The Attorney General shall award grants to States to enable the States to increase the participation of eligible collectors as authorized collectors.

SEC. 3254. Application.

A State desiring a covered grant shall submit to the Attorney General an application that, at a minimum—
(1)
identifies the single State agency that oversees pharmaceutical care and will be responsible for complying with the requirements of the grant;
(2)
details a plan to increase participation rates of eligible collectors as authorized collectors; and
(3)
describes how the State will select eligible collectors to be served under the grant.

SEC. 3255. Use of Grant Funds.

A State that receives a covered grant, and any subrecipient of the grant, may use the grant amounts only for the costs of installation, maintenance, training, purchasing, and disposal of controlled substances associated with the participation of eligible collectors as authorized collectors.

SEC. 3256. Eligibility for Grant.

The Attorney General shall award a covered grant to 5 States, not less than 3 of which shall be States in the lowest quartile of States based on the participation rate of eligible collectors as authorized collectors, as determined by the Attorney General.

SEC. 3257. Duration of Grants.

The Attorney General shall determine the period of years for which a covered grant is made to a State.

SEC. 3258. Accountability and Oversight.

A State that receives a covered grant shall submit to the Attorney General a report, at such time and in such manner as the Attorney General may reasonably require, that—
(1)
lists the ultimate recipients of the grant amounts;
(2)
describes the activities undertaken by the State using the grant amounts; and
(3)
contains performance measures relating to the effectiveness of the grant, including changes in the participation rate of eligible collectors as authorized collectors.

SEC. 3259. Duration of Program.

The Attorney General may award covered grants for each of the first 5 fiscal years beginning after the date of enactment of this Act.

SEC. 3260. Authorization of Appropriations.

There is authorized to be appropriated to the Attorney General such sums as may be necessary to carry out this chapter.

CHAPTER 7 Using Data to Prevent Opioid Diversion

SEC. 3271. Short Title.

This chapter may be cited as the “Using Data To Prevent Opioid Diversion Act of 2018”.

SEC. 3272. Purpose.

(a)
In General.— The purpose of this chapter is to provide drug manufacturers and distributors with access to anonymized information through the Automated Reports and Consolidated Orders System to help drug manufacturers and distributors identify, report, and stop suspicious orders of opioids and reduce diversion rates.
(b)
Rule of Construction.— Nothing in this chapter should be construed to absolve a drug manufacturer, drug distributor, or other Drug Enforcement Administration registrant from the responsibility of the manufacturer, distributor, or other registrant to—
(1)
identify, stop, and report suspicious orders; or
(2)
maintain effective controls against diversion in accordance with section 303 of the Controlled Substances Act (21 U.S.C. 823) or any successor law or associated regulation.

SEC. 3273. Amendments.

(a)
Records and Reports of Registrants.— Section 307 of the Controlled Substances Act (21 U.S.C. 827) is amended—
(1)
by redesignating subsections (f), (g), and (h) as subsections (g), (h), and (i), respectively;
(2)
by inserting after subsection (e) the following:

“(f)

(1) The Attorney General shall, not less frequently than quarterly, make the following information available to manufacturer and distributor registrants through the Automated Reports and Consolidated Orders System, or any subsequent automated system developed by the Drug Enforcement Administration to monitor selected controlled substances:

“(A) The total number of distributor registrants that distribute controlled substances to a pharmacy or practitioner registrant, aggregated by the name and address of each pharmacy and practitioner registrant.

“(B) The total quantity and type of opioids distributed, listed by Administration Controlled Substances Code Number, to each pharmacy and practitioner registrant described in subparagraph (A).

“(2) The information required to be made available under paragraph (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 and distributors 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 title against a registered manufacturer or distributor based on the failure of the registrant to maintain effective controls against diversion or otherwise comply with the requirements of this title 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.”

; and

(3)
by inserting after subsection (i), as so redesignated, the following:

“(j) All of the reports required under this section shall be provided in an electronic format.”

(b)
Cooperative Arrangements.— Section 503 of the Controlled Substances Act (21 U.S.C. 873) is amended by striking subsection (c) and inserting the following:

“(c)

(1) The Attorney General shall, once every 6 months, prepare and make available to regulatory, licensing, attorneys general, and law enforcement agencies of States a standardized report containing descriptive and analytic information on the actual distribution patterns, as gathered through the Automated Reports and Consolidated Orders System, or any subsequent automated system, pursuant to section 307 and which includes detailed amounts, outliers, and trends of distributor and pharmacy registrants, in such States for the controlled substances 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) once every 6 months as required under paragraph (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.”

(c)
Civil and Criminal Penalties.— Section 402 of the Controlled Substances Act (21 U.S.C. 842) is amended—
(1)
in subsection (a)—
(A)
in paragraph (15), by striking “ or” at the end;
(B)
in paragraph (16), by striking the period at the end and inserting “ ; or”; and
(C)
by inserting after paragraph (16) the following:

“(17) in the case of a registered manufacturer or distributor of opioids, to fail to review the most recent information, directly related to the customers of the manufacturer or distributor, made available by the Attorney General in accordance with section 307(f).”

; and

(2)
in subsection (c)—
(A)
in paragraph (1), by striking subparagraph (B) and inserting the following:

“(B)

(i) Except as provided in clause (ii), in the case of a violation of paragraph (5), (10), or (17) of subsection (a), the civil penalty shall not exceed $10,000.

“(ii) In the case of a violation described in clause (i) committed by a registered manufacturer or distributor of opioids and related to the reporting of suspicious orders for opioids, failing to maintain effective controls against diversion of opioids, or failing to review the most recent information made available by the Attorney General in accordance with section 307(f), the penalty shall not exceed $100,000.”

; and

(B)
in paragraph (2)—
(i)
in subparagraph (A), by inserting “ or (D)” after “ subparagraph (B)”; and
(ii)
by adding at the end the following:

“(D) In the case of a violation described in subparagraph (A) that was a violation of paragraph (5), (10), or (17) of subsection (a) committed by a registered manufacturer or distributor of opioids that relates to the reporting of suspicious orders for opioids, failing to maintain effective controls against diversion of opioids, or failing to review the most recent information made available by the Attorney General in accordance with section 307(f), the criminal fine under title 18, United States Code, shall not exceed $500,000.”

SEC. 3274. Report.

Not later than 1 year after the date of enactment of this Act, the Attorney General shall submit to Congress a report that provides information about how the Attorney General is using data in the Automation of Reports and Consolidated Orders System to identify and stop suspicious activity, including whether the Attorney General is looking at aggregate orders from individual pharmacies to multiple distributors that in total are suspicious, even if no individual order rises to the level of a suspicious order to a given distributor.

CHAPTER 8 Opioid Quota Reform

SEC. 3281. Short Title.

This chapter may be cited as the “Opioid Quota Reform Act”.

SEC. 3282. Strengthening Considerations for Dea Opioid Quotas.

(a)
In General.— Section 306 of the Controlled Substances Act (21 U.S.C. 826) is amended—
(1)
in subsection (a)—
(A)
by inserting “ (1)” after “ (a)”;
(B)
in the second sentence, by striking “ Production” and inserting “ Except as provided in paragraph (2), production”; and
(C)
by adding at the end the following:

“(2) The Attorney General may, if the Attorney General determines it will assist in avoiding the overproduction, shortages, or diversion of a controlled substance, establish an aggregate or individual production 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.”

(2)
in subsection (b), in the first sentence, by striking “ production” and inserting “ manufacturing”;
(3)
in subsection (c), by striking “ October” and inserting “ December”; and
(4)
by adding at the end the following:

“(i)

(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’), the Attorney General shall estimate the amount of diversion of the covered controlled substance that occurs in the United States.

“(B) In estimating diversion under this paragraph, the Attorney General—

“(i) shall consider information the Attorney General, in consultation with the Secretary 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 in the United States; 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, 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 quota for a covered controlled substance is higher than the approved aggregate production quota for the covered controlled substance for the previous year, the Attorney General, in consultation with the Secretary 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 available for sale, and potential diversion, in the United States.

“(B) Not later than 1 year after the date of enactment of this subsection, 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:

“(i) An anonymized count of the total number of manufacturers issued individual manufacturing quotas that year for the covered controlled substance.

“(ii) An anonymized count of how many such manufacturers were issued an approved manufacturing quota that was higher than the quota issued to that manufacturer for the covered controlled substance in the previous year.

“(3) Not later than 1 year after the date of enactment of this subsection, the Attorney General shall submit to Congress a report on how the Attorney General, when fixing and adjusting production and manufacturing quotas under this section for covered controlled substances, will—

“(A) take into consideration changes in the accepted medical use of the covered controlled substances; and

“(B) work with the Secretary of Health and Human Services on methods to appropriately and anonymously estimate the type and amount of covered controlled substances that are submitted for collection from approved drug collection receptacles, mail-back programs, and take-back events.”

(b)
Conforming Change.— The Law Revision Counsel is directed to amend the heading for subsection (b) of section 826 of title 21, United States Code, by striking “ Production” and inserting “ Manufacturing”.

CHAPTER 9 Preventing Drug Diversion

SEC. 3291. Short Title.

This chapter may be cited as the “Preventing Drug Diversion Act of 2018”.

SEC. 3292. Improvements to Prevent Drug Diversion.

(a)
Definition.— Section 102 of the Controlled Substances Act (21 U.S.C. 802) is amended by adding at the end the following:

“(57) The term ‘suspicious order’ may include, but is not limited to—

“(A) an order of a controlled substance of unusual size;

“(B) an order of a controlled substance deviating substantially from a normal pattern; and

“(C) orders of controlled substances of unusual frequency.”

(b)
Suspicious Orders.— Part C of the Controlled Substances Act (21 U.S.C. 821 et seq.) is amended by adding at the end the following:

“SEC. 312. SUSPICIOUS ORDERS.

“(a) Reporting.—Each registrant shall—

“(1) design and operate a system to identify suspicious orders for the registrant;

“(2) ensure that the system designed and operated under paragraph (1) by the registrant complies with applicable Federal and State privacy laws; and

“(3) upon discovering a suspicious order or series of orders, notify the Administrator of the Drug Enforcement Administration and the Special Agent in Charge of the Division Office of the Drug Enforcement Administration 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 the date of enactment of this section, the Attorney General shall establish a centralized database for collecting reports of suspicious orders.

“(2) Satisfaction of reporting requirements.—If a registrant reports a suspicious order to the centralized database established under paragraph (1), the registrant shall be considered to have complied with the requirement under subsection (a)(3) to notify the Administrator of the Drug Enforcement Administration and the Special Agent in Charge of the Division Office of the Drug Enforcement Administration 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 in a State, including information in the database established under subsection (b)(1), to the point of contact for purposes of administrative, civil, and criminal oversight relating to the diversion of controlled substances for the State, as designated by the Governor or chief executive officer of the State.

“(2) Timing.—The Attorney General shall provide information in accordance with paragraph (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 to ensure that the Attorney General has access to information, as permitted under State law, possessed by the States relating to prescriptions for controlled substances that will assist in enforcing Federal law.”

(c)
Reports to Congress.—
(1)
Definition.— In this subsection, the term “suspicious order” has the meaning given that term in section 102 of the Controlled Substances Act, as amended by this chapter.
(2)
One-time report.— Not later than 1 year after the date of enactment of this Act, the Attorney General shall submit to Congress a report on the reporting of suspicious orders, which shall include—
(A)
a description of the centralized database established under section 312 of the Controlled Substances Act, as added by this section, to collect reports of suspicious orders;
(B)
a description of the system and reports established under section 312 of the Controlled Substances Act, as added by this section, to share information with States;
(C)
information regarding how the Attorney General used reports of suspicious orders before the date of enactment of this Act and after the date of enactment of this Act, including how the Attorney General received the reports and what actions were taken in response to the reports; and
(D)
descriptions of the data analyses conducted on reports of suspicious orders to identify, analyze, and stop suspicious activity.
(3)
Additional reports.— Not later than 1 year after the date of enactment of this Act, and annually thereafter until the date that is 5 years after the date of enactment of this Act, the Attorney General shall submit to Congress a report providing, for the previous year—
(A)
the number of reports of suspicious orders;
(B)
a summary of actions taken in response to reports, in the aggregate, of suspicious orders; and
(C)
a description of the information shared with States based on reports of suspicious orders.
(4)
One-time gao report.— Not later than 1 year after the date of enactment of this Act, the Comptroller General of the United States, in consultation with the Administrator of the Drug Enforcement Administration, shall submit to Congress a report on the reporting of suspicious orders, which shall include an evaluation of the utility of real-time reporting of potential suspicious orders of opioids on a national level using computerized algorithms, including the extent to which such algorithms—
(A)
would help ensure that potentially suspicious orders are more accurately captured, identified, and reported in real time to suppliers before orders are filled;
(B)
may produce false positives of suspicious order reports that could result in market disruptions for legitimate orders of opioids; and
(C)
would reduce the overall length of an investigation that prevents the diversion of suspicious orders of opioids.