§811. Authority and criteria for classification of substances — Inbound Citations
21 U.S.C. § 811
Cited by 15 provisions in release 119-102.
Citations to 21 U.S.C. § 811 as a whole
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(A) The term “anabolic steroid” means any drug 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 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.
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(c) Schedules I, II, III, IV, and V shall, unless and until amended pursuant to section 811 of this title, consist of the following drugs or other substances,1 by whatever official name, common or usual name, chemical name, or brand name designated:
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(A) is controlled by action of the Attorney General under section 811 of this title; or
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(6) studies or special projects to develop information necessary to carry out his functions under section 811 of this title.
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(C) A description of whether each country identified pursuant to subparagraph (A) has adopted and utilizes scheduling or other procedures for illicit drugs that are similar in effect to the procedures authorized under title II1 of the Controlled Substances Act (21 U.S.C. 811 et seq.) for adding drugs and other substances to the controlled substances schedules;
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(B) designate each country, if any, identified under section 2291h(a)(10) of this title that has failed to adopt and utilize scheduling procedures for illicit drugs that are comparable to the procedures authorized under title II1 of the Controlled Substances Act (21 U.S.C. 811 et seq.) for adding drugs and other substances to the controlled substances schedules;
Citations to §811(a)
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(B) Such term does not include a product described in subparagraph (A) if the product contains a chemical specified in such subparagraph that the Attorney General has under section 811(a) of this title added to any of the schedules under section 812(c) of this title. 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.
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Whenever the Attorney General determines that there is evidence that—
Citations to §811(f)
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Whenever the Attorney General determines that there is evidence that—
Citations to §811(j)
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(1) In the case of an application under subsection (b) with respect to a drug for which the Secretary provides notice to the sponsor that the Secretary intends to issue a scientific and medical evaluation and recommend controls under the Controlled Substances Act [21 U.S.C. 801 et seq.], approval of such application shall not take effect until the interim final rule controlling the drug is issued in accordance with section 201(j) of the Controlled Substances Act [21 U.S.C. 811(j)].
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(1) In the case of an application under subsection (b) with respect to a drug for which the Secretary provides notice to the sponsor that the Secretary intends to issue a scientific and medical evaluation and recommend controls under the Controlled Substances Act [21 U.S.C. 801 et seq.], approval of such application shall not take effect until the interim final rule controlling the drug is issued in accordance with section 201(j) of the Controlled Substances Act [21 U.S.C. 811(j)].
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(A) In the case of an application under subsection (a) with respect to a drug for which the Secretary provides notice to the sponsor that the Secretary intends to issue a scientific and medical evaluation and recommend controls under the Controlled Substances Act [21 U.S.C. 801 et seq.], conditional approval of such application shall not take effect until the interim final rule controlling the drug is issued in accordance with section 201(j) of the Controlled Substances Act [21 U.S.C. 811(j)].
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(k) In the case of a request under subsection (d) to add a drug to the index under subsection (a) with respect to a drug for which the Secretary provides notice to the person filing the request that the Secretary intends to issue a scientific and medical evaluation and recommend controls under the Controlled Substances Act [21 U.S.C. 801 et seq.], a determination to grant the request to add such drug to the index shall not take effect until the interim final rule controlling the drug is issued in accordance with section 201(j) of the Controlled Substances Act [21 U.S.C. 811(j)].
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(3) For purposes of determining the 7-year period of exclusivity under paragraph (1) for a drug for which the Secretary intends to issue a scientific and medical evaluation and recommend controls under the Controlled Substances Act [21 U.S.C. 801 et seq.], the drug shall not be considered approved or conditionally approved until the date that the interim final rule controlling the drug is issued in accordance with section 201(j) of the Controlled Substances Act [21 U.S.C. 811(j)].
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(1) In the case of an application under subsection (a) with respect to a biological product for which the Secretary provides notice to the sponsor that the Secretary intends to issue a scientific and medical evaluation and recommend controls under the Controlled Substances Act [21 U.S.C. 801 et seq.], approval of such application shall not take effect until the interim final rule controlling the biological product is issued in accordance with section 201(j) of the Controlled Substances Act [21 U.S.C. 811(j)].