Statutes, codes, and regulations
Code of Federal Regulations
Title 21 - FOOD AND DRUGSChapter II - DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICEPart 1308 - SCHEDULES OF CONTROLLED SUBSTANCES
SCHEDULES
Section 1308.13 - Schedule III

21 C.F.R. § 1308.13

Download
PDF
Current through September 30, 2024
Section 1308.13 - Schedule III
(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:

(1) Those compounds, mixtures, or preparations in dosage unit form containing any stimulant substances listed in schedule II which compounds, mixtures, or preparations were listed on August 25, 1971, as excepted compounds under § 1308.32 , and any other drug of the quantitative composition shown in that list for those drugs or which is the same except that it contains a lesser quantity of controlled substances1405
(2) Benzphetamine1228
(3) Chlorphentermine1645
(4) Clortermine1647
(5) Phendimetrazine1615

(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:

(1) Any compound, mixture or preparation containing:
(i) Amobarbital2126
(ii) Secobarbital2316
(iii) Pentobarbital2271
or any salt thereof and one or more other active medicinal ingredients which are not listed in any schedule.
(2) Any suppository dosage form containing:
(i) Amobarbital2126
(ii) Secobarbital2316
(iii) Pentobarbital2271
or any salt of any of these drugs and approved by the Food and Drug Administration for marketing only as a suppository.
(3) Any substance which contains any quantity of a derivative of barbituric acid or any salt thereof2100
(4) Chlorhexadol2510
(5) Embutramide2020
(6) Any drug product containing gamma hydroxybutyric acid, including its salts, isomers, and salts of isomers, for which an application is approved under section 505 of the Federal Food, Drug, and Cosmetic Act2012
(7) Ketamine, its salts, isomers, and salts of isomers7285
[Some other names for ketamine: (±)-2-(2-chlorophenyl)-2-(methylamino)-cyclohexanone]
(8) Lysergic acid7300
(9) Lysergic acid amide7310
(10) Methyprylon2575
(11) Perampanel, and its salts, isomers, and salts of isomers2261
(12) Sulfondiethylmethane2600
(13) Sulfonethylmethane2605
(14) Sulfonmethane2610
(15) Tiletamine and zolazepam or any salt thereof7295
Some trade or other names for a tiletamine-zolazepam combination product:
Telazol
Some trade or other names for tiletamine:
2-(ethylamino)-2-(2-thienyl)-cyclohexanone
Some trade or other names for zolazepam:
4-(2-fluorophenyl)-6,8-dihydro-1,3,8-trimethylpyrazolo-[3,4-e] [1,4]-diazepin-7(1H)-one, flupyrazapon

(d) Nalorphine 9400.
(e)Narcotic drugs. Unless specifically excepted or unless listed in another schedule:

(1) 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:
(i) Not more than 1.8 grams of codeine per 100 milliliters or not more than 90 milligrams per dosage unit, with an equal or greater quantity of an isoquinoline alkaloid of opium9803
(ii) Not more than 1.8 grams of codeine per 100 milliliters or not more than 90 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts9804
(iii) Not more than 1.8 grams of dihydrocodeine per 100 milliliters or not more than 90 milligrams per dosage unit, with one or more active nonnarcotic ingredients in recognized therapeutic amounts9807
(iv) Not more than 300 milligrams of ethylmorphine per 100 milliliters or not more than 15 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts9808
(v) Not more than 500 milligrams of opium per 100 milliliters or per 100 grams or not more than 25 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts9809
(vi) Not more than 50 milligrams of morphine per 100 milliliters or per 100 grams, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts9810
(2) Any material, compound, mixture, or preparation containing any of the following narcotic drugs or their salts, as set forth below:
(i) Buprenorphine9064
(ii) [Reserved]

(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) 5[ALPHA]-androstan-3,17-dione;
(2) 5[ALPHA]-androstan-3,6,17-trione;
(3) 1-androstenediol (3[BETA],17[BETA]-dihydroxy-5[ALPHA]-androst-1-ene);
(4) 1-androstenediol (3[ALPHA],17[BETA]-dihydroxy-5[ALPHA]-androst-1-ene);
(5) 4-androstenediol (3[BETA],17[BETA]-dihydroxy-androst-4-ene);
(6) 5-androstenediol (3[BETA],17[BETA]-dihydroxy-androst-5-ene);
(7) 1-androstenedione (5[ALPHA]-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 (7[ALPHA],17[ALPHA]-dimethyl-17[BETA]-hydroxyandrost-4-en-3-one);
(11) boldenone (17[BETA]-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 (7[BETA],17[ALPHA]-dimethyl-17[BETA]-hydroxyandrost-4-en-3-one);
(16) 4-chloro-17[ALPHA]-methyl-androsta-1,4-diene-3,17[BETA]-diol;
(17) 4-chloro-17[ALPHA]-methyl-androst-4-ene-3[BETA],17[BETA]-diol;
(18) 4-chloro-17[ALPHA]-methyl-17[BETA]-hydroxy-androst-4-en-3-one;
(19) 4-chloro-17[ALPHA]-methyl-17[BETA]-hydroxy-androst-4-ene-3,11-dione;
(20) clostebol (4-chloro-17[BETA]-hydroxyandrost-4-en-3-one);
(21) dehydrochloromethyltestosterone (4-chloro-17[BETA]-hydroxy-17[ALPHA]-methyl-androst-1,4-dien-3-one);
(22) desoxymethyltestosterone (17[ALPHA]-methyl-5[ALPHA]-androst-2-en-17[BETA]-ol) (a.k.a. "madol");
(23) 4-dihydrotestosterone (17[BETA]-hydroxy-androstan-3-one);
(24) [DELTA]1-dihydrotestosterone (a.k.a. "1-testosterone") (17[BETA]-hydroxy-5[ALPHA]-androst-1-en-3-one);
(25) 3[BETA],17[BETA]-dihydroxy-5[ALPHA]-androstane;
(26) 3[ALPHA],17[BETA]-dihydroxy-5[ALPHA]-androstane;
(27) 2[ALPHA],17[ALPHA]-dimethyl-17[BETA]-hydroxy-5[BETA]-androstan-3-one;
(28) drostanolone (17[BETA]-hydroxy-2[ALPHA]-methyl-5[ALPHA]-androstan-3-one);
(29) 2[ALPHA],3[ALPHA]-epithio-17[ALPHA]-methyl-5[ALPHA]-androstan-17[BETA]-ol;
(30) estra-4,9,11-triene-3,17-dione;
(31) 13[BETA]-ethyl-17[BETA]-hydroxygon-4-en-3-one;
(32) ethylestrenol (17[ALPHA]-ethyl-17[BETA]-hydroxyestr-4-ene);
(33) fluoxymesterone (9-fluoro-17[ALPHA]-methyl-11[BETA],17[BETA]-dihydroxyandrost-4-en-3-one);
(34) formebolone (2-formyl-17[ALPHA]-methyl-11[ALPHA],17[BETA]-dihydroxyandrost-1,4-dien-3-one);
(35) furazabol (17[ALPHA]-methyl-17[BETA]-hydroxyandrostano[2,3-c]furazan);
(36) [3,2-c]furazan-5[ALPHA]-androstan-17[BETA]-ol;
(37) 18a-homo-3-hydroxy-estra-2,5(10)-dien-17-one;
(38) 4-hydroxy-19-nortestosterone (4,17[BETA]-dihydroxy-estr-4-en-3-one);
(39) 4-hydroxy-androst-4-ene-3,17-dione;
(40) 17[BETA]-hydroxy-androstano[2,3-d]isoxazole;
(41) 17[BETA]-hydroxy-androstano[3,2-c]isoxazole;
(42) 3[BETA]-hydroxy-estra-4,9,11-trien-17-one;
(43) 4-hydroxytestosterone (4,17[BETA]-dihydroxy-androst-4-en-3-one);
(44) mestanolone (17[ALPHA]-methyl-17[BETA]-hydroxy-5[ALPHA]-androstan-3-one);
(45) mesterolone (1[ALPHA]-methyl-17[BETA]-hydroxy-5[ALPHA]-androstan-3-one);
(46) methandienone (17[ALPHA]-methyl-17[BETA]-hydroxyandrost-1,4-dien-3-one);
(47) methandriol (17[ALPHA]-methyl-3[BETA],17[BETA]-dihydroxyandrost-5-ene);
(48) methasterone (2[ALPHA],17[ALPHA]-dimethyl-5[ALPHA]-androstan-17[BETA]-ol-3-one or 2[ALPHA],17[ALPHA]-dimethyl-17[BETA]-hydroxy-5[ALPHA]-androstan-3-one);
(49) methenolone (1-methyl-17[BETA]-hydroxy-5[ALPHA]-androst-1-en-3-one);
(50) 17[ALPHA]-methyl-androsta-1,4-diene-3,17[BETA]-diol;
(51) 17[ALPHA]-methyl-5[ALPHA]-androstan-17[BETA]-ol;
(52) 17[ALPHA]-methyl-androstan-3-hydroxyimine-17[BETA]-ol;
(53) 6[ALPHA]-methyl-androst-4-ene-3,17-dione;
(54) 17[ALPHA]-methyl-androst-2-ene-3,17[BETA]-diol;
(55) 17[ALPHA]-methyl-3[BETA],17[BETA]-dihydroxy-5[ALPHA]-androstane;
(56) 17[ALPHA]-methyl-3[ALPHA],17[BETA]-dihydroxy-5[ALPHA]-androstane;
(57) 17[ALPHA]-methyl-3[BETA],17[BETA]-dihydroxyandrost-4-ene;
(58) 17[ALPHA]-methyl-4-hydroxynandrolone (17[ALPHA]-methyl-4-hydroxy-17[BETA]-hydroxyestr-4-en-3-one);
(59) methyldienolone (17[ALPHA]-methyl-17[BETA]-hydroxyestra-4,9(10)-dien-3-one);
(60) 17[ALPHA]-methyl-[DELTA]1-dihydrotestosterone (17[BETA]-hydroxy-17[ALPHA]-methyl-5[ALPHA]-androst-1-en-3-one) (a.k.a. "17-[ALPHA]-methyl-1-testosterone");
(61) methyltestosterone (17[ALPHA]-methyl-17[BETA]-hydroxyandrost-4-en-3-one);
(62) methyltrienolone (17[ALPHA]-methyl-17[BETA]-hydroxyestra-4,9,11-trien-3-one);
(63) mibolerone (7[ALPHA],17[ALPHA]-dimethyl-17[BETA]-hydroxyestr-4-en-3-one);
(64) nandrolone (17[BETA]-hydroxyestr-4-en-3-one);
(65) 19-nor-4-androstenediol (3[BETA],17[BETA]-dihydroxyestr-4-ene);
(66) 19-nor-4-androstenediol (3[ALPHA],17[BETA]-dihydroxyestr-4-ene);
(67) 19-nor-5-androstenediol (3[BETA],17[BETA]-dihydroxyestr-5-ene);
(68) 19-nor-5-androstenediol (3[ALPHA],17[BETA]-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 (13[BETA],17[ALPHA]-diethyl-17[BETA]-hydroxygon-4-en-3-one);
(73) norclostebol (4-chloro-17[BETA]-hydroxyestr-4-en-3-one);
(74) norethandrolone (17[ALPHA]-ethyl-17[BETA]-hydroxyestr-4-en-3-one);
(75) normethandrolone (17[ALPHA]-methyl-17[BETA]-hydroxyestr-4-en-3-one);
(76) oxandrolone (17[ALPHA]-methyl-17[BETA]-hydroxy-2-oxa-5[ALPHA]-androstan-3-one);
(77) oxymesterone (17[ALPHA]-methyl-4,17[BETA]-dihydroxyandrost-4-en-3-one);
(78) oxymetholone (17[ALPHA]-methyl-2-hydroxymethylene-17[BETA]-hydroxy-5[ALPHA]-androstan-3-one);
(79) prostanozol (17[BETA]-hydroxy-5[ALPHA]-androstano[3,2-c]pyrazole or [3,2-c]pyrazole-5[ALPHA]-androstan-17[BETA]-ol);
(80) [3,2-c]pyrazole-androst-4-en-17[BETA]-ol;
(81) stanozolol (17[ALPHA]-methyl-17[BETA]-hydroxy-5[ALPHA]-androst-2-eno[3,2-c]-pyrazole);
(82) stenbolone (17[BETA]-hydroxy-2-methyl-5[ALPHA]-androst-1-en-3-one);
(83) testolactone (13-hydroxy-3-oxo-13,17-secoandrosta-1,4-dien-17-oic acid lactone);
(84) testosterone (17[BETA]-hydroxyandrost-4-en-3-one);
(85) tetrahydrogestrinone (13[BETA],17[ALPHA]-diethyl-17[BETA]-hydroxygon-4,9,11-trien-3-one); and
(86) trenbolone (17[BETA]-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.

[Some other names for dronabinol: (6aR-trans)-6a,7,8,10a-tetrahydro-6,6,9-trimethyl-3-pentyl-6 H-dibenzo [b,d]pyran-1-ol] or (-)-delta-9-(trans)-tetrahydrocannabinol]

(2) [Reserved]

21 C.F.R. §1308.13

39 FR 22142, June 20, 1974
88 FR 50040, 8/1/2023

For FEDERAL REGISTER citations affecting § 1308.13 , see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov.