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21 C.F.R. §§ 1308.11–1308.15

5 sections in range

§1308.11. Schedule I.

21 C.F.R. § 1308.11

(a)
Schedule I shall consist of the drugs and other substances, by whatever official name, common or usual name, chemical name, or brand name designated, listed in this section. Each drug or substance has been assigned the DEA Controlled Substances Code Number set forth opposite it.
(b)
Opiates. Unless specifically excepted or unless listed in another schedule, any of the following opiates, including their isomers, esters, ethers, salts, and salts of isomers, esters and ethers, whenever the existence of such isomers, esters, ethers and salts is possible within the specific chemical designation (for purposes of 3-methylthiofentanyl only, the term isomer includes the optical and geometric isomers):
(c)
Opium derivatives. Unless specifically excepted or unless listed in another schedule, any of the following opium derivatives, its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation:
(d)
Hallucinogenic substances. 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 its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation (for purposes of this paragraph only, the term “isomer” includes the optical, position and geometric isomers):
(e)
Depressants. 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, including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation:
(f)
Stimulants. 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, including its salts, isomers, and salts of isomers:
(g)
Cannabimimetic agents. Unless specifically exempted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of cannabimimetic agents, or which contains their salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation:
(h)
Temporary listing of substances subject to emergency scheduling. Any material, compound, mixture or preparation which contains any quantity of the following substances:
(i)
Fentanyl-related substance means any substance not otherwise listed under another Administration Controlled Substance Code Number, and for which no exemption or approval is in effect under section 505 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355], that is structurally related to fentanyl by one or more of the following modifications:
(A)
Replacement of the phenyl portion of the phenethyl group by any monocycle, whether or not further substituted in or on the monocycle;
(B)
Substitution in or on the phenethyl group with alkyl, alkenyl, alkoxyl, hydroxyl, halo, haloalkyl, amino or nitro groups;
(C)
Substitution in or on the piperidine ring with alkyl, alkenyl, alkoxyl, ester, ether, hydroxyl, halo, haloalkyl, amino or nitro groups;
(D)
Replacement of the aniline ring with any aromatic monocycle whether or not further substituted in or on the aromatic monocycle; and/or
(E)
Replacement of the <I>N</I>-propionyl group by another acyl group.
(ii)
This definition includes, but is not limited to, the following substances—
(A)
-(B) [Reserved]
Notes, amendments, and revision history

Amendments

[39 FR 22141, June 20, 1974]

Authority

Authority: 21 U.S.C. 811, 812, 871(b), 956(b), unless otherwise noted.

Source

Source: 38 FR 8254, Mar. 30, 1973, unless otherwise noted. Redesignated at 38 FR 26609, Sept. 24, 1973.

Amendments

[39 FR 22141, June 20, 1974]

§1308.12. Schedule II.

21 C.F.R. § 1308.12

(a)
Schedule II shall consist of the drugs and other substances, by whatever official name, common or usual name, chemical name, or brand name designated, listed in this section. Each drug or substance has been assigned the Controlled Substances Code Number set forth opposite it.
(b)
Substances, vegetable origin or chemical synthesis. 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, and any salt, compound, derivative, or preparation of opium or opiate excluding apomorphine, thebaine-derived butorphanol, dextrorphan, nalbuphine, naldemedine, nalmefene, naloxegol, naloxone, 6β-naltrexol, naltrexone, and samidorphan, and their respective salts, but including the following:
(2)
Any salt, compound, derivative, or preparation thereof which is chemically equivalent or identical with any of the substances referred to in paragraph (b) (1) of this section, except that these substances shall not include the isoquinoline alkaloids of opium.
(3)
Opium poppy and poppy straw.
(4)
Coca leaves (9040) and any salt, compound, derivative or preparation of coca leaves (including cocaine (9041) and ecgonine (9180) and their salts, isomers, derivatives and salts of isomers and derivatives), and any salt, compound, derivative, or preparation thereof which is chemically equivalent or identical with any of these substances, except that the substances shall not include:
(i)
Decocainized coca leaves or extraction of coca leaves, which extractions do not contain cocaine or ecgonine;
(ii)
[ 123I]ioflupane; or
(iii)
[ 18F]FP-CIT.
(5)
Concentrate of poppy straw (the crude extract of poppy straw in either liquid, solid or powder form which contains the phenanthrene alkaloids of the opium poppy), 9670.
(c)
Opiates. Unless specifically excepted or unless in another schedule any of the following opiates, including its isomers, esters, ethers, salts and salts of isomers, esters and ethers whenever the existence of such isomers, esters, ethers, and salts is possible within the specific chemical designation, dextrorphan and levopropoxyphene excepted:
(d)
Stimulants. 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:
(e)
Depressants. 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, including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation:
(f)
Hallucinogenic substances.
(g)
Immediate precursors. Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances:
(1)
Immediate precursor to amphetamine and methamphetamine—
(2)
Immediate precursors to phencyclidine (PCP)—
(3)
Immediate precursor to fentanyl—
Notes, amendments, and revision history

Amendments

[39 FR 22142, June 20, 1974]

Authority

Authority: 21 U.S.C. 811, 812, 871(b), 956(b), unless otherwise noted.

Source

Source: 38 FR 8254, Mar. 30, 1973, unless otherwise noted. Redesignated at 38 FR 26609, Sept. 24, 1973.

Amendments

[39 FR 22142, June 20, 1974]

§1308.13. Schedule III.

21 C.F.R. § 1308.13

(a)
Schedule III shall consist of the drugs and other substances, by whatever official name, common or usual name, chemical name, or brand name designated, listed in this section. Each drug or substance has been assigned the DEA Controlled Substances Code Number set forth opposite it.
(b)
Stimulants. 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, including its salts, isomers (whether optical, positional, or geometric), and salts of such isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation:
(c)
Depressants. 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:
(d)
Nalorphine 9400.
(e)
Narcotic drugs. Unless specifically excepted or unless listed in another schedule:
(f)
Anabolic steroids. Unless specifically excepted or unless listed in another schedule, any substance meeting the definition of anabolic steroid as set forth in § 1300.01 of this chapter, including any material, compound, mixture or preparation containing any quantity of the following substances, including its salts, esters and ethers (4000):
(1)
5α-androstan-3,17-dione;
(2)
5α-androstan-3,6,17-trione;
(3)
1-androstenediol (3β,17β-dihydroxy-5α-androst-1-ene);
(4)
1-androstenediol (3α,17β-dihydroxy-5α-androst-1-ene);
(5)
4-androstenediol (3β,17β-dihydroxy-androst-4-ene);
(6)
5-androstenediol (3β,17β-dihydroxy-androst-5-ene);
(7)
1-androstenedione (5α-androst-1-en-3,17-dione);
(8)
4-androstenedione (androst-4-en-3,17-dione);
(9)
5-androstenedione (androst-5-en-3,17-dione);
(10)
bolasterone (7α,17α-dimethyl-17β-hydroxyandrost-4-en-3-one);
(11)
boldenone (17β-hydroxyandrost-1,4-diene-3-one);
(12)
boldione (androsta-1,4-diene-3,17-dione);
(13)
6-bromo-androsta-1,4-diene-3,17-dione;
(14)
6-bromo-androstan-3,17-dione;
(15)
calusterone (7β,17α-dimethyl-17β-hydroxyandrost-4-en-3-one);
(16)
4-chloro-17α-methyl-androsta-1,4-diene-3,17β-diol;
(17)
4-chloro-17α-methyl-androst-4-ene-3β,17β-diol;
(18)
4-chloro-17α-methyl-17β-hydroxy-androst-4-en-3-one;
(19)
4-chloro-17α-methyl-17β-hydroxy-androst-4-ene-3,11-dione;
(20)
clostebol (4-chloro-17β-hydroxyandrost-4-en-3-one);
(21)
dehydrochloromethyltestosterone (4-chloro-17β-hydroxy-17α-methyl-androst-1,4-dien-3-one);
(22)
desoxymethyltestosterone (17α-methyl-5α-androst-2-en-17β-ol) (a.k.a. “madol”);
(23)
4-dihydrotestosterone (17β-hydroxy-androstan-3-one);
(24)
Δ1-dihydrotestosterone (a.k.a. “1-testosterone”) (17β-hydroxy-5α-androst-1-en-3-one);
(25)
3β,17β-dihydroxy-5α-androstane;
(26)
3α,17β-dihydroxy-5α-androstane;
(27)
2α,17α-dimethyl-17β-hydroxy-5β-androstan-3-one;
(28)
drostanolone (17β-hydroxy-2α-methyl-5α-androstan-3-one);
(29)
2α,3α-epithio-17α-methyl-5α-androstan-17β-ol;
(30)
estra-4,9,11-triene-3,17-dione;
(31)
13β-ethyl-17β-hydroxygon-4-en-3-one;
(32)
ethylestrenol (17α-ethyl-17β-hydroxyestr-4-ene);
(33)
fluoxymesterone (9-fluoro-17α-methyl-11β,17β-dihydroxyandrost-4-en-3-one);
(34)
formebolone (2-formyl-17α-methyl-11α,17β-dihydroxyandrost-1,4-dien-3-one);
(35)
furazabol (17α-methyl-17β-hydroxyandrostano[2,3-c]furazan);
(36)
[3,2-c]furazan-5α-androstan-17β-ol;
(37)
18a-homo-3-hydroxy-estra-2,5(10)-dien-17-one;
(38)
4-hydroxy-19-nortestosterone (4,17β-dihydroxy-estr-4-en-3-one);
(39)
4-hydroxy-androst-4-ene-3,17-dione;
(40)
17β-hydroxy-androstano[2,3-d]isoxazole;
(41)
17β-hydroxy-androstano[3,2-c]isoxazole;
(42)
3β-hydroxy-estra-4,9,11-trien-17-one;
(43)
4-hydroxytestosterone (4,17β-dihydroxy-androst-4-en-3-one);
(44)
mestanolone (17α-methyl-17β-hydroxy-5α-androstan-3-one);
(45)
mesterolone (1α-methyl-17β-hydroxy-5α-androstan-3-one);
(46)
methandienone (17α-methyl-17β-hydroxyandrost-1,4-dien-3-one);
(47)
methandriol (17α-methyl-3β,17β-dihydroxyandrost-5-ene);
(48)
methasterone (2α,17α-dimethyl-5α-androstan-17β-ol-3-one or 2α,17α-dimethyl-17β-hydroxy-5α-androstan-3-one);
(49)
methenolone (1-methyl-17β-hydroxy-5α-androst-1-en-3-one);
(50)
17α-methyl-androsta-1,4-diene-3,17β-diol;
(51)
17α-methyl-5α-androstan-17β-ol;
(52)
17α-methyl-androstan-3-hydroxyimine-17β-ol;
(53)
6α-methyl-androst-4-ene-3,17-dione;
(54)
17α-methyl-androst-2-ene-3,17β-diol;
(55)
17α-methyl-3β,17β-dihydroxy-5α-androstane;
(56)
17α-methyl-3α,17β-dihydroxy-5α-androstane;
(57)
17α-methyl-3β,17β-dihydroxyandrost-4-ene;
(58)
17α-methyl-4-hydroxynandrolone (17α-methyl-4-hydroxy-17β-hydroxyestr-4-en-3-one);
(59)
methyldienolone (17α-methyl-17β-hydroxyestra-4,9(10)-dien-3-one);
(60)
17α-methyl-Δ1-dihydrotestosterone (17β-hydroxy-17α-methyl-5α-androst-1-en-3-one) (a.k.a. “17-α-methyl-1-testosterone”);
(61)
methyltestosterone (17α-methyl-17β-hydroxyandrost-4-en-3-one);
(62)
methyltrienolone (17α-methyl-17β-hydroxyestra-4,9,11-trien-3-one);
(63)
mibolerone (7α,17α-dimethyl-17β-hydroxyestr-4-en-3-one);
(64)
nandrolone (17β-hydroxyestr-4-en-3-one);
(65)
19-nor-4-androstenediol (3β,17β-dihydroxyestr-4-ene);
(66)
19-nor-4-androstenediol (3α,17β-dihydroxyestr-4-ene);
(67)
19-nor-5-androstenediol (3β,17β-dihydroxyestr-5-ene);
(68)
19-nor-5-androstenediol (3α,17β-dihydroxyestr-5-ene);
(69)
19-nor-4,9(10)-androstadienedione (estra-4,9(10)-diene-3,17-dione);
(70)
19-nor-4-androstenedione (estr-4-en-3,17-dione);
(71)
19-nor-5-androstenedione (estr-5-en-3,17-dione);
(72)
norbolethone (13β,17α-diethyl-17β-hydroxygon-4-en-3-one);
(73)
norclostebol (4-chloro-17β-hydroxyestr-4-en-3-one);
(74)
norethandrolone (17α-ethyl-17β-hydroxyestr-4-en-3-one);
(75)
normethandrolone (17α-methyl-17β-hydroxyestr-4-en-3-one);
(76)
oxandrolone (17α-methyl-17β-hydroxy-2-oxa-5α-androstan-3-one);
(77)
oxymesterone (17α-methyl-4,17β-dihydroxyandrost-4-en-3-one);
(78)
oxymetholone (17α-methyl-2-hydroxymethylene-17β-hydroxy-5α-androstan-3-one);
(79)
prostanozol (17β-hydroxy-5α-androstano[3,2-c]pyrazole or [3,2-c]pyrazole-5α-androstan-17β-ol);
(80)
[3,2-c]pyrazole-androst-4-en-17β-ol;
(81)
stanozolol (17α-methyl-17β-hydroxy-5α-androst-2-eno[3,2-c]-pyrazole);
(82)
stenbolone (17β-hydroxy-2-methyl-5α-androst-1-en-3-one);
(83)
testolactone (13-hydroxy-3-oxo-13,17-secoandrosta-1,4-dien-17-oic acid lactone);
(84)
testosterone (17β-hydroxyandrost-4-en-3-one);
(85)
tetrahydrogestrinone (13β,17α-diethyl-17β-hydroxygon-4,9,11-trien-3-one); and
(86)
trenbolone (17β-hydroxyestr-4,9,11-trien-3-one).
(g)
Hallucinogenic substances.
(1)
Dronabinol (synthetic) in sesame oil and encapsulated in a soft gelatin capsule in a U.S. Food and Drug Administration approved product—7369.
(2)
Marijuana, as defined in 21 U.S.C. 802(16), in a U.S. Food and Drug Administration approved product or subject to a state medical marijuana license—XXXX
(3)
Marijuana extract, as defined in 21 CFR 1308.11(d)(58), in a U.S. Food and Drug Administration approved product or subject to a state medical marijuana license—XXXX
(4)
Naturally derived delta-9-tetrahydrocannabinols in a U.S. Food and Drug Administration approved product or in marijuana subject to a state medical marijuana license—XXXX
(i)
Naturally derived delta-9-tetrahydrocannabinols means those delta-9-tetrahydrocannabinols, except as in paragraphs (g)(2) and (3) of this section, that are naturally contained in a plant of the genus Cannabis (cannabis plant).
(ii)
Naturally derived delta-9-tetrahydrocannabinols do not include any material, compound, mixture, or preparation that falls within the definition of hemp set forth in 7 U.S.C. 1639o.
(iii)
Naturally derived delta-9-tetrahydrocannabinols do not include any delta-9-tetrahydrocannabinols contained in substances excluded from the definition of marijuana as set forth in 21 U.S.C. 802(16)(B)(ii).
(5)
[Reserved]—XXXX
Notes, amendments, and revision history

Amendments

[39 FR 22142, June 20, 1974]

Authority

Authority: 21 U.S.C. 811, 812, 871(b), 956(b), unless otherwise noted.

Source

Source: 38 FR 8254, Mar. 30, 1973, unless otherwise noted. Redesignated at 38 FR 26609, Sept. 24, 1973.

Amendments

[39 FR 22142, June 20, 1974]

§1308.14. Schedule IV.

21 C.F.R. § 1308.14

(a)
Schedule IV shall consist of the drugs and other substances, by whatever official name, common or usual name, chemical name, or brand name designated, listed in this section. Each drug or substance has been assigned the DEA Controlled Substances Code Number set forth opposite it.
(b)
Narcotic drugs. Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation containing any of the following narcotic drugs, or their salts calculated as the free anhydrous base or alkaloid, in limited quantities as set forth below:
(c)
Depressants. Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances, including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation:
(d)
[Reserved]
(e)
Lorcaserin. Any material, compound, mixture, or preparation which contains any quantity of the following substances, including its salts, isomers, and salts of such isomers, whenever the existence of such salts, isomers, and salts of isomers is possible:
(f)
Stimulants. 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, including its salts, isomers and salts of isomers:
(g)
Other substances. Unless specifically excepted or unless listed in another schedule, any material, compound, mixture or preparation which contains any quantity of the following substances, including its salts:
Notes, amendments, and revision history

Amendments

[39 FR 22143, June 20, 1974]

Authority

Authority: 21 U.S.C. 811, 812, 871(b), 956(b), unless otherwise noted.

Source

Source: 38 FR 8254, Mar. 30, 1973, unless otherwise noted. Redesignated at 38 FR 26609, Sept. 24, 1973.

Amendments

[39 FR 22143, June 20, 1974]

§1308.15. Schedule V.

21 C.F.R. § 1308.15

(a)
Schedule V shall consist of the drugs and other substances, by whatever official name, common or usual name, chemical name, or brand name designated, listed in this section.
(b)
Narcotic drugs. Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation containing any of the following narcotic drugs and their salts, as set forth below:
(1)
[Reserved]
(2)
[Reserved]
(c)
Narcotic drugs containing non-narcotic active medicinal ingredients. Any compound, mixture, or preparation containing any of the following narcotic drugs, or their salts calculated as the free anhydrous base or alkaloid, in limited quantities as set forth below, which shall include one or more non-narcotic active medicinal ingredients in sufficient proportion to confer upon the compound, mixture, or preparation valuable medicinal qualities other than those possessed by narcotic drugs alone:
(1)
Not more than 200 milligrams of codeine per 100 milliliters or per 100 grams.
(2)
Not more than 100 milligrams of dihydrocodeine per 100 milliliters or per 100 grams.
(3)
Not more than 100 milligrams of ethylmorphine per 100 milliliters or per 100 grams.
(4)
Not more than 2.5 milligrams of diphenoxylate and not less than 25 micrograms of atropine sulfate per dosage unit.
(5)
Not more than 100 milligrams of opium per 100 milliliters or per 100 grams.
(6)
Not more than 0.5 milligram of difenoxin and not less than 25 micrograms of atropine sulfate per dosage unit.
(d)
Stimulants. Unless specifically exempted or excluded 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, including its salts, isomers and salts of isomers:
(e)
Depressants. Unless specifically exempted or excluded 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, including its salts:
Notes, amendments, and revision history

Amendments

[39 FR 22143, June 20, 1974, as amended at 43 FR 38383, Aug. 28, 1978; 44 FR 40888, July 13, 1979; 47 FR 49841, Nov. 3, 1982; 50 FR 8108, Feb. 28, 1985; 52 FR 5952, Feb. 27, 1987; 53 FR 10870, Apr. 4, 1988; 56 FR 61372, Dec. 3, 1991; 67 FR 62370, Oct. 7, 2002; 70 FR 43635, July 28, 2005; 74 FR 23790, May 21, 2009; 76 FR 77899, Dec. 15, 2011; 81 FR 29491, May 12, 2016; 83 FR 48953, Sept 28, 2018; 85 FR 5562, Jan. 31, 2020; 85 FR 13746, Mar. 10, 2020; 85 FR 51645, Aug. 21, 2020; 87 FR 32996, June 1, 2022]

Authority

Authority: 21 U.S.C. 811, 812, 871(b), 956(b), unless otherwise noted.

Source

Source: 38 FR 8254, Mar. 30, 1973, unless otherwise noted. Redesignated at 38 FR 26609, Sept. 24, 1973.

Amendments

[39 FR 22143, June 20, 1974, as amended at 43 FR 38383, Aug. 28, 1978; 44 FR 40888, July 13, 1979; 47 FR 49841, Nov. 3, 1982; 50 FR 8108, Feb. 28, 1985; 52 FR 5952, Feb. 27, 1987; 53 FR 10870, Apr. 4, 1988; 56 FR 61372, Dec. 3, 1991; 67 FR 62370, Oct. 7, 2002; 70 FR 43635, July 28, 2005; 74 FR 23790, May 21, 2009; 76 FR 77899, Dec. 15, 2011; 81 FR 29491, May 12, 2016; 83 FR 48953, Sept 28, 2018; 85 FR 5562, Jan. 31, 2020; 85 FR 13746, Mar. 10, 2020; 85 FR 51645, Aug. 21, 2020; 87 FR 32996, June 1, 2022]