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Drug Enforcement Administration, Justice § 1308.13

Sections Affected, which appears in the (6) Any drug product containing gamma hydroxybutyric Finding Aids section of the printed volume acid, including its salts, isomers, and salts of iso- and at www.fdsys.gov. mers, for which an application is approved under section 505 of the Federal Food, Drug, and Cos- metic Act ...... 2012 § 1308.13 Schedule III. (7) , its salts, isomers, and salts of isomers .. 7285 (a) Schedule III shall consist of the [Some other names for ketamine: (±)-2-(2- drugs and other substances, by what- chlorophenyl)-2-(methylamino)-cyclohexanone] (8) Lysergic acid ...... 7300 ever official name, common or usual (9) Lysergic acid amide ...... 7310 name, chemical name, or brand name (10) ...... 2575 designated, listed in this section. Each (11) Sulfondiethylmethane ...... 2600 drug or substance has been assigned (12) Sulfonethylmethane ...... 2605 (13) ...... 2610 the DEA Controlled Substances Code (14) and zolazepam or any salt thereof ...... 7295 Number set forth opposite it. Some trade or other names for a tiletamine- (b) Stimulants. Unless specifically ex- zolazepam combination product: Telazol.. cepted or unless listed in another Some trade or other names for tiletamine: schedule, any material, compound, 2-(ethylamino)-2-(2-thienyl)-cyclohexanone.. mixture, or preparation which contains Some trade or other names for zolazepam: any quantity of the following sub- 4-(2-fluorophenyl)-6,8-dihydro-1,3,8- trimethylpyrazolo-[3,4-e] [1,4]-diazepin- stances having a stimulant effect on 7(1H)-one, flupyrazapon.. the central nervous system, including its salts, isomers (whether optical, po- (d) Nalorphine 9400. sitional, or geometric), and salts of (e) Narcotic drugs. Unless specifically such isomers whenever the existence of excepted or unless listed in another such salts, isomers, and salts of iso- schedule: mers is possible within the specific (1) Any material, compound, mixture, or preparation containing any of the following narcotic drugs, or chemical designation: their salts calculated as the free anhydrous base or (1) Those compounds, mixtures, or preparations in alkaloid, in limited quantities as set forth below: dosage unit form containing any stimulant sub- (i) Not more than 1.8 grams of codeine per stances listed in schedule II which compounds, mix- 100 milliliters or not more than 90 milli- tures, or preparations were listed on August 25, grams per dosage unit, with an equal or 1971, as excepted compounds under § 1308.32, and greater quantity of an isoquinoline alkaloid any other drug of the quantitative composition of opium ...... 9803 shown in that list for those drugs or which is the (ii) Not more than 1.8 grams of codeine per same except that it contains a lesser quantity of 100 milliliters or not more than 90 milli- controlled substances ...... 1405 grams per dosage unit, with one or more (2) Benzphetamine ...... 1228 active, nonnarcotic ingredients in recog- (3) Chlorphentermine ...... 1645 nized therapeutic amounts ...... 9804 (4) Clortermine ...... 1647 (iii) Not more than 300 milligrams of (5) Phendimetrazine ...... 1615 dihydrocodeinone (hydrocodone) per 100 milliliters or not more than 15 milligrams (c) Depressants. Unless specifically per dosage unit, with a fourfold or greater excepted or unless listed in another quantity of an isoquinoline alkaloid of opium ...... 9805 schedule, any material, compound, (iv) Not more than 300 milligrams of mixture, or preparation which contains dihydrocodeinone (hydrocodone) per 100 any quantity of the following sub- milliliters or not more than 15 milligrams stances having a depressant effect on per dosage unit, with one or more active nonnarcotic ingredients in recognized the central nervous system: therapeutic amounts ...... 9806 (1) Any compound, mixture or preparation containing: (v) Not more than 1.8 grams of (i) ...... 2126 dihydrocodeine per 100 milliliters or not (ii) ...... 2316 more than 90 milligrams per dosage unit, (iii) ...... 2271 with one or more active nonnarcotic ingre- or any salt thereof and one or more other active dients in recognized therapeutic amounts ... 9807 medicinal ingredients which are not listed in any (vi) Not more than 300 milligrams of schedule. ethylmorphine per 100 milliliters or not (2) Any suppository dosage form containing: more than 15 milligrams per dosage unit, with one or more active, nonnarcotic ingre- (i) Amobarbital ...... 2126 dients in recognized therapeutic amounts ... 9808 (ii) Secobarbital ...... 2316 (vii) Not more than 500 milligrams of opium (iii) Pentobarbital ...... 2271 per 100 milliliters or per 100 grams or not or any salt of any of these drugs and approved by more than 25 milligrams per dosage unit, the Food and Drug Administration for marketing with one or more active, nonnarcotic ingre- only as a suppository. dients in recognized therapeutic amounts ... 9809 (3) Any substance which contains any quantity of a (viii) Not more than 50 milligrams of morphine derivative of barbituric acid or any salt thereof ...... 2100 per 100 milliliters or per 100 grams, with (4) Chlorhexadol ...... 2510 one or more active, nonnarcotic ingredients (5) Embutramide ...... 2020 in recognized therapeutic amounts ...... 9810 111

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(2) Any material, compound, mixture, or preparation stances, including its salts, isomers, containing any of the following narcotic drugs or and salts of isomers whenever the ex- their salts, as set forth below: (i) Buprenorphine ...... 9064 istence of such salts, isomers, and salts (ii) [Reserved]. of isomers is possible within the spe- (f) Anabolic Steroids. Unless specifi- cific chemical designation: cally excepted or unless listed in an- (1) ...... 2882 (2) ...... 2145 other schedule, any material, com- (3) ...... 2748 pound, mixture or preparation con- (4) ...... 2749 taining any quantity of the following (5) ...... 8192 (6) betaine ...... 2460 substances, including its salts, esters (7) ...... 2465 and ethers: (8) ...... 2744 (1) Anabolic steroids (see § 1300.01 of (9) ...... 2751 (10) ...... 2737 this chapter)—4000 (11) ...... 2768 (2) [Reserved] (12) ...... 2752 (13) ...... 2753 (g) Hallucinogenic substances. (1) (14) ...... 2754 Dronabinol (synthetic) in sesame oil (15) ...... 2765 and encapsulated in a soft gelatin cap- (16) ...... 2467 (17) ...... 2756 sule in a U.S. Food and Drug Adminis- (18) ...... 2540 tration approved product—7369. (19) ...... 2545 (20) ...... 2758 [Some other names for dronabinol: (6aR- (21) ...... 2759 trans)-6a,7,8,10a-tetrahydro-6,6,9-trimethyl-3- (22) ...... 2763 pentyl-6H-dibenzo [b,d]pyran-1-ol] or (-)- (23) ...... 2767 delta-9-(trans)-tetrahydrocannabinol] (24) ...... 2138 (25) ...... 2762 (2) [Reserved] (26) ...... 2771 (27) ...... 2772 [39 FR 22142, June 20, 1974] (28) ...... 2773 (29) ...... 2885 EDITORIAL NOTE: For FEDERAL REGISTER ci- (30) ...... 2774 tations affecting § 1308.13, see the List of CFR (31) ...... 2800 Sections Affected, which appears in the (32) ...... 2836 Finding Aids section of the printed volume (33) ...... 2820 and at www.fdsys.gov. (34) ...... 2264 (35) (mephobarbital) ...... 2250 § 1308.14 Schedule IV. (36) ...... 2884 (37) ...... 2837 (a) Schedule IV shall consist of the (38) ...... 2834 drugs and other substances, by what- (39) Nordiazepam ...... 2838 (40) ...... 2835 ever official name, common or usual (41) ...... 2839 name, chemical name, or brand name (42) ...... 2585 designated, listed in this section. Each (43) ...... 2591 (44) ...... 2285 drug or substance has been assigned (45) ...... 2883 the DEA Controlled Substances Code (46) ...... 2764 Number set forth opposite it. (47) ...... 2881 (b) Narcotic drugs. Unless specifically (48) ...... 2925 (49) ...... 2886 excepted or unless listed in another (50) ...... 2887 schedule, any material, compound, (51) ...... 2781 mixture, or preparation containing any (52) ...... 2783 of the following narcotic drugs, or (53) ...... 2784 their salts calculated as the free anhy- (d) Fenfluramine. Any material, com- drous base or alkaloid, in limited quan- pound, mixture, or preparation which tities as set forth below: contains any quantity of the following (1) Not more than 1 milligram of difenoxin and not less substances, including its salts, isomers than 25 micrograms of atropine sulfate per dosage (whether optical, position, or geo- unit ...... 9167 (2) Dextropropoxyphene (alpha-(+)-4-dimethylamino- metric), and salts of such isomers, 1,2-diphenyl-3-methyl-2-propionoxybutane) ...... 9278 whenever the existence of such salts, isomers, and salts of isomers is pos- (c) Depressants. Unless specifically sible: excepted or unless listed in another schedule, any material, compound, (1) Fenfluramine ...... 1670 mixture, or preparation which contains (e) Stimulants. Unless specifically ex- any quantity of the following sub- cepted or unless listed in another 112

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