21 CFR Part 1308 · Schedules of Controlled Substances

21 CFR 1308.13

Schedule III

21 CFR 1308.13 is the regulation titled “Schedule III” in 21 CFR Part 1308, Schedules of Controlled Substances. Since 2021, 1 FDA warning letter has cited it.

Letters citing it
1 since 2021
Jan 1 to Oct 30, 2026
0 against 0 on the same dates in 2025
Most often cited with
21 CFR 201.128, in 1 letter
Closed out
0% of these letters have a published close-out
See the letter citing 21 CFR 1308.13 →

Letters citing it, by year issued

It is a drug letter. 2026 runs to Oct 30, 2026. Pick a year to see its letters.

  1. 02021
  2. 02022
  3. 02023
  4. 02024
  5. 12025
  6. 02026

The regulation

Read the text of 21 CFR 1308.13 (eCFR, as of Sep 1, 2026)

(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

[39 FR 22142, June 20, 1974]

Text from eCFR as of Sep 1, 2026.

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