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§ 1308.14 21 CFR Ch. II (4–1–13 Edition)

(2) Any material, compound, mixture, or preparation stances, including its salts, isomers, containing any of the following narcotic 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 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) . 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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schedule, any material, compound, (1) Not more than 200 milligrams of mixture, or preparation which contains codeine per 100 milliliters or per 100 any quantity of the following sub- grams. stances having a stimulant effect on (2) Not more than 100 milligrams of the central nervous system, including dihydrocodeine per 100 milliliters or its salts, isomers and salts of isomers: per 100 grams. (1) Cathine ((+)-norpseudoephedrine) ...... 1230 (3) Not more than 100 milligrams of (2) Diethylpropion ...... 1610 (3) Fencamfamin ...... 1760 ethylmorphine per 100 milliliters or per (4) Fenproporex ...... 1575 100 grams. (5) Mazindol ...... 1605 (6) Mefenorex ...... 1580 (4) Not more than 2.5 milligrams of (7)Modafinil ...... 1680 diphenoxylate and not less than 25 (8) Pemoline (including organometallic complexes and micrograms of atropine sulfate per dos- chelates thereof) ...... 1530 (9) Phentermine ...... 1640 age unit. (10) Pipradrol ...... 1750 (5) Not more than 100 milligrams of (11) Sibutramine ...... 1675 opium per 100 milliliters or per 100 (12) SPA ((-)-1-dimethylamino- 1,2-diphenylethane) .... 1635 grams. (f) Other substances. Unless specifi- (6) Not more than 0.5 milligram of cally excepted or unless listed in an- difenoxin and not less than 25 other schedule, any material, com- micrograms of atropine sulfate per dos- pound, mixture or preparation which age unit. contains any quantity of the following substances, including its salts: (d) Stimulants. Unless specifically ex- empted or excluded or unless listed in (1) Pentazocine ...... 9709 (2) Butorphanol (including its optical isomers) ...... 9720 another schedule, any material, com- pound, mixture, or preparation which [39 FR 22143, June 20, 1974] contains any quantity of the following EDITORIAL NOTE: For FEDERAL REGISTER ci- substances having a stimulant effect tations affecting § 1308.14, see the List of CFR on the central nervous system, includ- Sections Affected, which appears in the ing its salts, isomers and salts of iso- Finding Aids section of the printed volume mers: and at www.fdsys.gov. (1) Pyrovalerone ...... 1485. § 1308.15 Schedule V. (2) [Reserved] (a) Schedule V shall consist of the (e) Depressants. Unless specifically drugs and other substances, by what- exempted or excluded or unless listed ever official name, common or usual in another schedule, any material, name, chemical name, or brand name compound, mixture, or preparation designated, listed in this section. which contains any quantity of the fol- (b) Narcotic drugs. Unless specifically lowing substances having a excepted or unless listed in another effect on the central nervous system, schedule, any material, compound, including its salts: mixture, or preparation containing any (1) Ezogabine [N-[2-amino-4-(4- of the following narcotic drugs and fluorobenzylamino)-phenyl]-carbamic their salts, as set forth below: (1) [Reserved] acid ethyl ester]–2779 (c) Narcotic drugs containing non-nar- (2) Lacosamide [(R)-2-acetoamido-N- cotic active medicinal ingredients. Any benzyl-3-methoxy-propionamide]—2746 compound, mixture, or preparation (3) [(S)-3-(aminomethyl)- containing any of the following nar- 5-methylhexanoic acid]—2782 cotic drugs, or their salts calculated as [39 FR 22143, June 20, 1974, as amended at 43 the free anhydrous base or alkaloid, in FR 38383, Aug. 28, 1978; 44 FR 40888, July 13, limited quantities as set forth below, 1979; 47 FR 49841, Nov. 3, 1982; 50 FR 8108, Feb. which shall include one or more non- 28, 1985; 52 FR 5952, Feb. 27, 1987; 53 FR 10870, narcotic active medicinal ingredients Apr. 4, 1988; 56 FR 61372, Dec. 3, 1991; 67 FR in sufficient proportion to confer upon 62370, Oct. 7, 2002; 70 FR 43635, July 28, 2005; the compound, mixture, or preparation 74 FR 23790, May 21, 2009; 76 FR 77899, Dec. 15, valuable medicinal qualities other than 2011] those possessed by narcotic drugs alone:

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