21 C.F.R. § 1308.13 Schedule III.
Title 21 - Food and Drugs
Title 21: Food and Drugs
PART 1308—SCHEDULES OF CONTROLLED SUBSTANCES
Schedules
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§ 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 sxstem, including its salts, isomers (whether optical, position, 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 1405 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 substances........................(2) Benzphetamine................................................ 1228(3) Chlorphentermine............................................. 1645(4) Clortermine.................................................. 1647(5) Phendimetrazine.............................................. 1615
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(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:
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(1) Any compound, mixture or preparation containing: (i) Amobarbital.............................................. 2126 (ii) Secobarbital............................................ 2316 (iii) Pentobarbital.......................................... 2271 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) Amobarbital.............................................. 2126 (ii) Secobarbital............................................ 2316 (iii) Pentobarbital.......................................... 2271 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 2100 barbituric acid or any salt thereof.............................(4) Chlorhexadol................................................. 2510(5) Any drug product containing gamma hydroxybutyric acid, 2012 including its salts, isomers, and salts of isomers, for which an application is approved under section 505 of the Federal Food, Drug, and Cosmetic Act..........................................(6) Ketamine, its salts, isomers, and salts of isomers........... 7285 [Some other names for ketamine: (±)-2-(2-chlorophenyl)-2- (methylamino)-cyclohexanone](7) Lysergic acid................................................ 7300(8) Lysergic acid amide.......................................... 7310(9) Methyprylon.................................................. 2575(10) Sulfondiethylmethane........................................ 2600(11) Sulfonethylmethane.......................................... 2605(12) Sulfonmethane............................................... 2610(13) Tiletamine and zolazepam or any salt thereof................ 7295 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...................
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(d) Nalorphine 9400.
(e) Narcotic drugs. Unless specifically excepted or unless listed in another schedule:
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(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 9803 not more than 90 milligrams per dosage unit, with an equal or greater quantity of an isoquinoline alkaloid of opium.... (ii) Not more than 1.8 grams of codeine per 100 milliliters 9804 or not more than 90 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts......................................... (iii) Not more than 300 milligrams of dihydrocodeinone 9805 (hydrocodone) per 100 milliliters or not more than 15 milligrams per dosage unit, with a fourfold or greater quantity of an isoquinoline alkaloid of opium............... (iv) Not more than 300 milligrams of dihydrocodeinone 9806 (hydrocodone) per 100 milliliters or not more than 15 milligrams per dosage unit, with one or more active nonnarcotic ingredients in recognized therapeutic amounts... (v) Not more than 1.8 grams of dihydrocodeine per 100 9807 milliliters or not more than 90 milligrams per dosage unit, with one or more active nonnarcotic ingredients in recognized therapeutic amounts.............................. (vi) Not more than 300 milligrams of ethylmorphine per 100 9808 milliliters or not more than 15 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts.............................. (vii) Not more than 500 milligrams of opium per 100 9809 milliliters or per 100 grams or not more than 25 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts............... (viii) Not more than 50 milligrams of morphine per 100 9810 milliliters or per 100 grams, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts... (2) Any material, compound, mixture, or preparation containing any of the following narcotic drugs or their salts, as set forth below: (i) Buprenorphine............................................ 9064 (ii) [Reserved]..............................................
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(f) Anabolic Steroids. Unless specifically excepted or unless listed in another schedule, any material, compound, mixture or preparation containing any quantity of the following substances, including its salts, esters and ethers:
(1) Anabolic steroids (see §1300.01 of this chapter)—4000
(2) [Reserved]
(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-6H-dibenzo [b,d]pyran-1-ol] or (-)-delta-9-(trans)-tetrahydrocannabinol]
(2) [Reserved]
[39 FR 22142, June 20, 1974, as amended at 41 FR 43401, Oct. 1, 1976; 43 FR 3359, Jan. 25, 1978; 44 FR 40888, July 13, 1979; 46 FR 52334, Oct. 27, 1981; 51 FR 5320, Feb. 13, 1986; 52 FR 2222, Jan. 21, 1987; 52 FR 5952, Feb. 27, 1987; 56 FR 5754, Feb. 13, 1991; 56 FR 11932, Mar. 21, 1991; 62 FR 13968, Mar. 24, 1997; 64 FR 35930, July 2, 1999; 64 FR 37675, July 13, 1999; 65 FR 13238, Mar. 13, 2000; 65 FR 17440, Apr. 3, 2000; 67 FR 62370, Oct. 7, 2002; 70 FR 74657, Dec. 16, 2005]
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