§ 1308.11 21 CFR Ch. II (4–1–01 Edition)
and on certain order forms issued by (4) Alphacetylmethadol (except levo- the Administration pursuant to alphacetylmethadol also known as levo-alpha- acetylmethadol, levomethadyl acetate, or LAAM) ..... 9603 § 1305.05(d) of this chapter. Applicants (5) Alphameprodine ...... 9604 for procurement and/or individual man- (6) Alphamethadol ...... 9605 ufacturing quotas must include the ap- (7) Alpha-methylfentanyl (N-[1-(alpha-methyl-beta- propriate code number on the applica- phenyl)ethyl-4-piperidyl] propionanilide; 1-(1-methyl- 2-phenylethyl)-4-(N-propanilido) piperidine) ...... 9814 tion as required in §§ 1303.12(b) and (8) Alpha-methylthiofentanyl (N-[1-methyl-2-(2- 1303.22(a) of this chapter. Applicants thienyl)ethyl-4-piperidinyl]-N-phenylpropanamide) ..... 9832 for import and export permits must in- (9) Benzethidine ...... 9606 (10) Betacetylmethadol ...... 9607 clude the appropriate code number on (11) Beta-hydroxyfentanyl (N-[1-(2-hydroxy-2- the application as required in phenethyl)-4-piperidinyl]-N-phenylpropanamide) ...... 9830 §§ 1312.12(a) and 1312.22(a) of this chap- (12) Beta-hydroxy-3-methylfentanyl (other name: N-[1- ter. Authorized registrants who desire (2-hydroxy-2-phenethyl)-3-methyl-4-piperidinyl]-N- phenylpropanamide ...... 9831 to import or export a controlled sub- (13) Betameprodine ...... 9608 stance for which an import or export (14) Betamethadol ...... 9609 permit is not required must include the (15) Betaprodine ...... 9611 appropriate Administration Controlled (16) Clonitazene ...... 9612 (17) Dextromoramide ...... 9613 Substances Code Number beneath or (18) Diampromide ...... 9615 beside the name of each controlled sub- (19) Diethylthiambutene ...... 9616 stance listed on the DEA Form 236 (20) Difenoxin ...... 9168 (Controlled Substance Import/Export (21) Dimenoxadol ...... 9617 (22) Dimepheptanol ...... 9618 Declaration) which is executed for such (23) Dimethylthiambutene ...... 9619 importation or exportation as required (24) Dioxaphetyl butyrate ...... 9621 in §§ 1312.18(c) and 1312.27(b) of this (25) Dipipanone ...... 9622 (26) Ethylmethylthiambutene ...... 9623 chapter. (27) Etonitazene ...... 9624 (b) Except as stated in paragraph (a) (28) Etoxeridine ...... 9625 of this section, no applicant or reg- (29) Furethidine ...... 9626 istrant is required to use the Adminis- (30) Hydroxypethidine ...... 9627 (31) Ketobemidone ...... 9628 tration Controlled Substances Code (32) Levomoramide ...... 9629 Number for any purpose. (33) Levophenacylmorphan ...... 9631 (34) 3-Methylfentanyl (N-[3-methyl-1-(2-phenylethyl)-4- [38 FR 8254, Mar. 30, 1973. Redesignated at 38 piperidyl]-N-phenylpropanamide) ...... 9813 FR 26609, Sept. 24, 1973 and amended at 51 FR (35) 3-methylthiofentanyl (N-[(3-methyl-1-(2- 15318, Apr. 23, 1986; 62 FR 13968, Mar. 24, 1997] thienyl)ethyl-4-piperidinyl]-N-phenylpropanamide) ..... 9833 (36) Morpheridine ...... 9632 SCHEDULES (37) MPPP (1-methyl-4-phenyl-4-propionoxypiperidine) 9661 (38) Noracymethadol ...... 9633 (39) Norlevorphanol ...... 9634 § 1308.11 Schedule I. (40) Normethadone ...... 9635 (a) Schedule I shall consist of the (41) Norpipanone ...... 9636 (42) Para-fluorofentanyl (N-(4-fluorophenyl)-N-[1-(2- drugs and other substances, by what- phenethyl)-4-piperidinyl] propanamide ...... 9812 ever official name, common or usual (43) PEPAP (1-(-2-phenethyl)-4-phenyl-4- name, chemical name, or brand name acetoxypiperidine ...... 9663 designated, listed in this section. Each (44) Phenadoxone ...... 9637 (45) Phenampromide ...... 9638 drug or substance has been assigned (46) Phenomorphan ...... 9647 the DEA Controlled Substances Code (47) Phenoperidine ...... 9641 Number set forth opposite it. (48) Piritramide ...... 9642 (49) Proheptazine ...... 9643 (b) Opiates. Unless specifically ex- (50) Properidine ...... 9644 cepted or unless listed in another (51) Propiram ...... 9649 schedule, any of the following opiates, (52) Racemoramide ...... 9645 including their isomers, esters, ethers, (53) Thiofentanyl (N-phenyl-N-[1-(2-thienyl)ethyl-4- piperidinyl]-propanamide ...... 9835 salts, and salts of isomers, esters and (54) Tilidine ...... 9750 ethers, whenever the existence of such (55) Trimeperidine ...... 9646 isomers, esters, ethers and salts is pos- (c) Opium derivatives. Unless specifi- sible within the specific chemical des- cally excepted or unless listed in an- ignation (for purposes of paragraph other schedule, any of the following (b)(34) only, the term isomer includes opium derivatives, its salts, isomers, the optical and geometric isomers): and salts of isomers whenever the ex- (1) Acetyl-alpha-methylfentanyl (N-[1-(1-methyl-2- istence of such salts, isomers, and salts phenethyl)-4-piperidinyl]-N-phenylacetamide) ...... 9815 (2) Acetylmethadol ...... 9601 of isomers is possible within the spe- (3) Allylprodine ...... 9602 cific chemical designation: 82
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(1) Acetorphine ...... 9319 (12) N-hydroxy-3,4-methylenedioxyamphetamine (also (2) Acetyldihydrocodeine ...... 9051 known as N-hydroxy-alpha-methyl- (3) Benzylmorphine ...... 9052 3,4(methylenedioxy)phenethylamine, and N-hydroxy (4) Codeine methylbromide ...... 9070 MDA ...... 7402 (13) 3,4,5-trimethoxy amphetamine ...... 7390 (5) Codeine-N-Oxide ...... 9053 (14) Bufotenine ...... 7433 (6) Cyprenorphine ...... 9054 Some trade and other names: 3-(β (7) Desomorphine ...... 9055 -Dimethylaminoethyl)-5-hydroxyindole; 3-(2- (8) Dihydromorphine ...... 9145 dimethylaminoethyl)-5-indolol; N, N- (9) Drotebanol ...... 9335 dimethylserotonin; 5-hydroxy-N,N- (10) Etorphine (except hydrochloride salt) ...... 9056 dimethyltryptamine; mappine (11) Heroin ...... 9200 (15) Diethyltryptamine ...... 7434 (12) Hydromorphinol ...... 9301 Some trade and other names: N,N- (13) Methyldesorphine ...... 9302 Diethyltryptamine; DET (14) Methyldihydromorphine ...... 9304 (16) Dimethyltryptamine ...... 7435 (15) Morphine methylbromide ...... 9305 Some trade or other names: DMT (16) Morphine methylsulfonate ...... 9306 (17) Ibogaine ...... 7260 (17) Morphine-N-Oxide ...... 9307 Some trade and other names: 7-Ethyl- (18) Myrophine ...... 9308 6,6β,7,8,9,10,12,13-octahydro-2-methoxy-6,9- (19) Nicocodeine ...... 9309 methano-5H-pyrido [1′, 2′:1,2] azepino [5,4-b] (20) Nicomorphine ...... 9312 indole; Tabernanthe iboga (21) Normorphine ...... 9313 (18) Lysergic acid diethylamide ...... 7315 (22) Pholcodine ...... 9314 (19) Marihuana ...... 7360 (23) Thebacon ...... 9315 (20) Mescaline ...... 7381 (21) Parahexyl—7374; some trade or other names: 3- (d) Hallucinogenic substances. Unless Hexyl-1-hydroxy-7,8,9,10-tetrahydro-6,6,9-trimethyl- specifically excepted or unless listed in 6H-dibenzo[b,d]pyran; Synhexyl. another schedule, any material, com- (22) Peyote ...... 7415 Meaning all parts of the plant presently classified pound, mixture, or preparation, which botanically as Lophophora williamsii Lemaire, contains any quantity of the following whether growing or not, the seeds thereof, any hallucinogenic substances, or which extract from any part of such plant, and every compound, manufacture, salts, derivative, mixture, contains any of its salts, isomers, and or preparation of such plant, its seeds or extracts salts of isomers whenever the existence (Interprets 21 USC 812(c), Schedule I(c) (12)) of such salts, isomers, and salts of iso- (23) N-ethyl-3-piperidyl benzilate ...... 7482 mers is possible within the specific (24) N-methyl-3-piperidyl benzilate ...... 7484 (25) Psilocybin ...... 7437 chemical designation (for purposes of (26) Psilocyn ...... 7438 this paragraph only, the term ‘‘isomer’’ (27) Tetrahydrocannabinols ...... 7370 includes the optical, position and geo- Synthetic equivalents of the substances contained in the plant, or in the resinous extractives of Can- metric isomers): nabis, sp. and/or synthetic substances, deriva- (1) Alpha-ethyltryptamine ...... 7249 tives, and their isomers with similar chemical Some trade or other names: etryptamine; Monase; structure and pharmacological activity such as the α-ethyl-1H-indole-3-ethanamine; 3-(2-aminobutyl) following: indole; α-ET; and AET. ∆1 cis or trans tetrahydrocannabinol, and their opti- (2) 4-bromo-2,5-dimethoxy-amphetamine ...... 7391 cal isomers Some trade or other names: 4-bromo-2,5- ∆6 cis or trans tetrahydrocannabinol, and their opti- dimethoxy-α-methylphenethylamine; 4-bromo-2,5- cal isomers DMA ∆3,4 cis or trans tetrahydrocannabinol, and its opti- (3) 4-Bromo-2,5-dimethoxyphenethylamine ...... 7392 cal isomers Some trade or other names: 2-(4-bromo-2,5- (Since nomenclature of these substances is not dimethoxyphenyl)-1-aminoethane; alpha- internationally standardized, compounds of these desmethyl DOB; 2C-B, Nexus. structures, regardless of numerical designation of (4) 2,5-dimethoxyamphetamine ...... 7396 atomic positions covered.) Some trade or other names: 2,5-dimethoxy-α- (28) Ethylamine analog of phencyclidine ...... 7455 methylphenethylamine; 2,5-DMA Some trade or other names: N-ethyl-1- (5) 2,5-dimethoxy-4-ethylamphet-amine ...... 7399 phenylcyclohexylamine, (1- Some trade or other names: DOET phenylcyclohexyl)ethylamine, N-(1- (6) 4-methoxyamphetamine ...... 7411 phenylcyclohexyl)ethylamine, cyclohexamine, PCE Some trade or other names: 4-methoxy-α- (29) Pyrrolidine analog of phencyclidine ...... 7458 methylphenethylamine; Some trade or other names: 1-(1-phenylcyclohexyl)- paramethoxyamphetamine, PMA pyrrolidine, PCPy, PHP (7) 5-methoxy-3,4-mdthylenedioxy-amphetamine ...... 7401 (30) Thiophene analog of phencyclidine ...... 7470 Some trade or other names: 1-[1-(2-thienyl)- (8) 4-methyl-2,5-dimethoxy-amphetamine ...... 7395 cyclohexyl]-piperidine, 2-thienylanalog of Some trade and other names: 4-methyl-2,5- phencyclidine, TPCP, TCP dimethoxy-α-methylphenethylamine; ‘‘DOM’’; and (31) 1-[1-(2-thienyl)cyclohexyl]pyrrolidine ...... 7473 ‘‘STP’’ Some other names: TCPy (9) 3,4-methylenedioxy amphetamine ...... 7400 (10) 3,4-methylenedioxymethamphetamine (MDMA) .... 7405 (e) Depressants. Unless specifically (11) 3,4-methylenedioxy-N-ethylamphetamine (also excepted or unless listed in another known as N-ethyl-alpha-methyl- 3,4(methylenedioxy)phenethylamine, N-ethyl MDA, schedule, any material, compound, MDE, MDEA ...... 7404 mixture, or preparation which contains 83
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any quantity of the following sub- § 1308.12 Schedule II. stances having a depressant effect on (a) Schedule II shall consist of the the central nervous system, including drugs and other substances, by what- its salts, isomers, and salts of isomers ever official name, common or usual whenever the existence of such salts, name, chemical name, or brand name isomers, and salts of isomers is possible designated, listed in this section. Each within the specific chemical designa- drug or substance has been assigned tion: the Controlled Substances Code Num- (1) gamma-hydroxybutyric acid (some other names in- ber set forth opposite it. clude GHB; gamma-hydroxybutyrate; 4- (b) Substances, vegetable origin or hydroxybutyrate; 4-hydroxybutanoic acid; sodium oxybate; sodium oxybutyrate) ...... 2010 chemical synthesis. Unless specifically (2) Mecloqualone ...... 2572 excepted or unless listed in another (3) Methaqualone ...... 2565 schedule, any of the following sub- stances whether produced directly or (f) Stimulants. Unless specifically ex- indirectly by extraction from sub- cepted or unless listed in another stances of vegetable origin, or inde- schedule, any material, compound, pendently by means of chemical syn- mixture, or preparation which contains thesis, or by a combination of extrac- any quantity of the following sub- tion and chemical synthesis: stances having a stimulant effect on (1) Opium and opiate, and any salt, the central nervous system, including compound, derivative, or preparation its salts, isomers, and salts of isomers: of opium or opiate excluding (1) Aminorex (Some other names: aminoxaphen; 2- apomorphine, thebaine-derived amino-5-phenyl-2-oxazoline; or 4,5-dihydro-5- butorphanol, dextrorphan, nalbuphine, phenly-2-oxazolamine) ...... 1585 nalmefene, naloxone, and naltrexone, (2) Cathinone ...... 1235 Some trade or other names: 2-amino-1-phenyl-1- and their respective salts, but includ- propanone, alpha-aminopropiophenone, 2- ing the following: aminopropiophenone, and norephedrone (1) Raw opium ...... 9600 (3) Fenethylline ...... 1503 (2) Opium extracts ...... 9610 (4) Methcathinone (Some other names: 2- (3) Opium fluid ...... 9620 (methylamino)-propiophenone; alpha- (4) Powdered opium ...... 9639 (methylamino)propiophenone; 2-(methylamino)-1- (5) Granulated opium ...... 9640 phenylpropan-1-one; alpha-N- (6) Tincture of opium ...... 9630 methylaminopropiophenone; monomethylpropion; (7) Codeine ...... 9050 ephedrone; N-methylcathinone; methylcathinone; (8) Dihydroetorphine ...... 9334 AL–464; AL–422; AL–463 and UR1432), its salts, (9) Ethylmorphine ...... 9190 optical isomers and salts of optical isomers ...... 1237 (10) Etorphine hydrochloride ...... 9059 (5) (±)cis-4-methylaminorex ((±)cis-4,5-dihydro-4-meth- (11) Hydrocodone ...... 9193 yl-5-phenyl-2-oxazolamine) ...... 1590 (12) Hydromorphone ...... 9150 (13) Metopon ...... 9260 (6) N-ethylamphetamine ...... 1475 (14) Morphine ...... 9300 (7) N,N-dimethylamphetamine (also known as N,N- (15) Oxycodone ...... 9143 alpha-trimethyl-benzeneethanamine; N,N-alpha- (16) Oxymorphone ...... 9652 trimethylphenethylamine) ...... 1480 (17) Thebaine ...... 9333 (g) Temporary listing of substances sub- (2) Any salt, compound, derivative, or ject to emergency scheduling. Any mate- preparation thereof which is chemi- rial, compound, mixture or preparation cally equivalent or identical with any which contains any quantity of the fol- of the substances referred to in para- lowing substances: graph (b) (1) of this section, except that (1) N-[1-benzyl-4-piperidyl]-N-phenylpropanamide these substances shall not include the (benzylfentanyl), its optical isomers, salts and salts isoquinoline alkaloids of opium. of isomers ...... 9818 (3) Opium poppy and poppy straw. (2) N-[1-(2-thienyl)methyl-4-piperidyl]-N- phenylpropanamide (thenylfentanyl), its optical (4) Coca leaves (9040) and any salt, isolers, salts and salts of isomers ...... 9834 compound, derivative or preparation of coca leaves (including cocaine (9041) [39 FR 22141, June 20, 1974] and ecgonine (9180) and their salts, iso- mers, derivatives and salts of isomers EDITORIAL NOTE: For FEDERAL REGISTER ci- tations affecting § 1308.11, see the List of CFR and derivatives), and any salt, com- Sections Affected, which appears in the pound, derivative, or preparation Finding Aids section of the printed volume thereof which is chemically equivalent and on GPO Access. or identical with any of these sub- stances, except that the substances
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shall not include decocainized coca (e) Depressants. Unless specifically leaves or extraction of coca leaves, excepted or unless listed in another whhch extractions do not contain co- schedule, any material, compound, caine or ecgonine. mixture, or preparation which contains (5) Concentrate of poppy straw (the any quantity of the following sub- crude extract of poppy straw in either stances having a depressant effect on liquid, solid or powder form which con- the central nervous system, including tains the phenanthrene alkaloids of the its salts, isomers, and salts of isomers opium poppy), 9670. whenever the existence of such salts, (c) Opiates. Unless specifically ex- isomers, and salts of isomers is possible cepted or unless in another schedule within the specific chemical designa- any of the following opiates, including tion: its isomers, esters, ethers, salts and (1) Amobarbital ...... 2125 (2) Glutethimide ...... 2550 salts of isomers, esters and ethers (3) Pentobarbital ...... 2270 whenever the existence of such iso- (4) Phencyclidine ...... 7471 mers, esters, ethers, and salts is pos- (5) Secobarbital ...... 2315 sible within the specific chemical des- (f) Hallucinogenic substances. ignation, dextrorphan and (1) Nabilone ...... 7379 levopropoxyphene excepted: [Another name for nabilone: (±)-trans-3-(1,1- (1) Alfentanil ...... 9737 dimethylheptyl)-6,6a,7,8,10,10a-hexahydro-1-hy- droxy-6,6-dimethyl-9H-dibenzo[b,d]pyran-9-one] (2) Alphaprodine ...... 9010 (3) Anileridine ...... 9020 (g) Immediate precursors. Unless spe- (4) Bezitramide ...... 9800 cifically excepted or unless listed in (5) Bulk dextropropoxyphene (non-dosage forms) ...... 9273 (6) Carfentanil ...... 9743 another schedule, any material, com- (7) Dihydrocodeine ...... 9120 pound, mixture, or preparation which (8) Diphenoxylate ...... 9170 contains any quantity of the following (9) Fentanyl ...... 9801 substances: (10) Isomethadone ...... 9226 (11) Levo-alphacetylmethadol ...... 9648 (1) Immediate precursor to amphet- [Some other names: levo-alpha-acetylmethadol, amine and methamphetamine: levomethadyl acetate, LAAM] (i) Phenylacetone ...... 8501 (12) Levomethorphan ...... 9210 Some trade or other names: phenyl-2-propanone; (13) Levorphanol ...... 9220 P2P; benzyl methyl ketone; methyl benzyl ke- (14) Metazocine ...... 9240 tone; (15) Methadone ...... 9250 (16) Methadone-Intermediate, 4-cyano-2- (2) Immediate precursors to dimethylamino-4,4-diphenyl butane ...... 9254 phencyclidine (PCP): (17) Moramide-Intermediate, 2-methyl-3-morpholino-1, (i) 1-phenylcyclohexylamine ...... 7460 1-diphenylpropane-carboxylic acid ...... 9802 (ii) 1-piperidinocyclohexanecarbonitrile (PCC) ...... 8603 (18) Pethidine (meperidine) ...... 9230 (19) Pethidine-Intermediate-A, 4-cyano-1-methyl-4- [39 FR 22142, June 20, 1974] phenylpiperidine ...... 9232 (20) Pethidine-Intermediate-B, ethyl-4- EDITORIAL NOTE: For FEDERAL REGISTER ci- phenylpiperidine-4-carboxylate ...... 9233 tations affecting § 1308.12, see the List of CFR (21) Pethidine-Intermediate-C, 1-methyl-4- Sections Affected, which appears in the phenylpiperidine-4-carboxylic acid ...... 9234 Finding Aids section of the printed volume (22) Phenazocine ...... 9715 and on GPO Access. (23) Piminodine ...... 9730 (24) Racemethorphan ...... 9732 (25) Racemorphan ...... 9733 § 1308.13 Schedule III. (26) Remifentanil ...... 9739 (a) Schedule III shall consist of the (27) Sufentanil ...... 9740 drugs and other substances, by what- (d) Stimulants. Unless specifically ex- ever official name, common or usual cepted or unless listed in another name, chemical name, or brand name schedule, any material, compound, designated, listed in this section. Each mixture, or preparation which contains drug or substance has been assigned any quantity of the following sub- the DEA Controlled Substances Code stances having a stimulant effect on Number set forth opposite it. the central nervous system: (b) Stimulants. Unless specifically ex- (1) Amphetamine, its salts, optical isomers, and salts cepted or unless listed in another of its optical isomers ...... 1100 schedule, any material, compound, (2) Methamphetamine, its salts, isomers, and salts of mixture, or preparation which contains its isomers ...... 1105 (3) Phenmetrazine and its salts ...... 1631 any quantity of the following sub- (4) Methylphenidate ...... 1724 stances having a stimulant effect on
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the central nervous sxstem, including (e) Narcotic Drugs. Unless specifically its salts, isomers (whether optical, po- excepted or unless listed in another sition, or geometric), and salts of such schedule, any material, compound, isomers whenever the existence of such mixture, or preparation containing any salts, isomers, and salts of isomers is of the following narcotic drugs, or possible within the specific chemical their salts calculated as the free anhy- designation: drous base or alkaloid, in limited quan- (1) Those compounds, mixtures, or preparations in tities as set forth below: dosage unit form containing any stimulant sub- stances listed in schedule II which compounds, mix- (1) Not more than 1.8 grams of codeine per 100 milli- tures, or preparations were listed on August 25, liters or not more than 90 milligrams per dosage 1971, as excepted compounds under § 1308.32, and unit, with an equal or greater quantity of an any other drug of the quantitative composition isoquinoline alkaloid of opium ...... 9803 shown in that list for those drugs or which is the (2) Not more than 1.8 grams of codeine per 100 milli- same except that it contains a lesser quantity of liters or not more than 90 milligrams per dosage controlled substances ...... 1405 unit, with one or more active, nonnarcotic ingredi- (2) Benzphetamine ...... 1228 ents in recognized therapeutic amounts ...... 9804 (3) Chlorphentermine ...... 1645 (3) Not more than 300 milligrams of dihydrocodeinone (4) Clortermine ...... 1647 (hydrocodone) per 100 milliliters or not more than (5) Phendimetrazine ...... 1615 15 milligrams per dosage unit, with a fourfold or greater quantity of an isoquinoline alkaloid of opium 9805 (c) Depressants. Unless specifically (4) Not more than 300 milligrams of dihydrocodeinone excepted or unless listed in another (hydrocodone) per 100 milliliters or not more than schedule, any material, compound, 15 milligrams per dosage unit, with one or more ac- tive nonnarcotic ingredients in recognized thera- mixture, or preparation which contains peutic amounts ...... 9806 any quantity of the following sub- (5) Not more than 1.8 grams of dihydrocodeine per stances having a depressant effect on 100 milliliters or not more than 90 milligrams per the central nervous system: dosage unit, with one or more active nonnarcotic in- gredients in recognized therapeutic amounts ...... 9807 (1) Any compound, mixture or preparation containing: (6) Not more than 300 milligrams of ethylmorphine per (i) Amobarbital ...... 2126 100 milliliters or not more than 15 milligrams per (ii) Secobarbital ...... 2316 dosage unit, with one or more active, nonnarcotic in- (iii) Pentobarbital ...... 2271 gredients in recognized therapeutic amounts ...... 9808 or any salt thereof and one or more other active (7) Not more than 500 milligrams of opium per 100 medicinal ingredients which are not listed in any milliliters or per 100 grams or not more than 25 milli- schedule. grams per dosage unit, with one or more active, (2) Any suppository dosage form containing: nonnarcotic ingredients in recognized therapeutic (i) Amobarbital ...... 2126 amounts ...... 9809 (ii) Secobarbital ...... 2316 (8) Not more than 50 milligrams of morphine per 100 (iii) Pentobarbital ...... 2271 milliliters or per 100 grams, with one or more active, or any salt of any of these drugs and approved by nonnarcotic ingredients in recognized therapeutic the Food and Drug Administration for marketing amounts ...... 9810 only as a suppository. (3) Any substance which contains any quantity of a (f) Anabolic steroids. Unless specifi- derivative of barbituric acid or any salt thereof ...... 2100 cally excepted or unless listed in an- (4) Chlorhexadol ...... 2510 (5) Any drug product containing gamma hydroxybutyric other schedule, any material, com- acid, including its salts, isomers, and salts of iso- pound, mixture, or preparation con- mers, for which an application is approved under taining any quantity of the following section 505 of the Federal Food, Drug, and Cos- metic Act ...... 2012 substances, including its salts, isomers, (6) Ketamine, its salts, isomers, and salts of isomers .. 7285 and salts of isomers whenever the ex- ± [Some other names for ketamine: ( )-2-(2- istence of such salts of isomers is pos- chlorophenyl)-2-(methylamino)-cyclohexanone] (7) Lysergic acid ...... 7300 sible within the specific chemical des- (8) Lysergic acid amide ...... 7310 ignation: (9) Methyprylon ...... 2575 (10) Sulfondiethylmethane ...... 2600 (1) Anabolic Steroids ...... 4000 (11) Sulfonethylmethane ...... 2605 (12) Sulfonmethane ...... 2610 (g) Hallucinogenic substances. (13) Tiletamine and zolazepam or any salt thereof ...... 7295 Some trade or other names for a tiletamine- (1) Dronabinol (synthetic) in sesame oil zolazepam combination product: and encapsulated in a soft gelatin capsule in Telazol.. a U.S. Food and Drug Administration ap- Some trade or other names for tiletamine: proved product—7369. 2-(ethylamino)-2-(2-thienyl)-cyclohexanone.. Some trade or other names for zolazepam: [Some other names for dronabinol: (6aR- 4-(2-fluorophenyl)-6,8-dihydro-1,3,8- trans)-6a,7,8,10a-tetrahydro-6,6,9-trimethyl-3- trimethylpyrazolo-[3,4-e] [1,4]-diazepin- 7(1H)-one, flupyrazapon.. pentyl-6H-dibenzo [b,d]pyran-1-ol] or (-)- delta-9-(trans)-tetrahydrocannabinol] (d) Nalorphine 9400.
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(2) [Reserved] (23) Haloxazolam ...... 2771 (24) Ketazolam ...... 2772 [39 FR 22142, June 20, 1974, as amended at 41 (25) Loprazolam ...... 2773 FR 43401, Oct. 1, 1976; 43 FR 3359, Jan. 25, 1978; (26) Lorazepam ...... 2885 44 FR 40888, July 13, l979; 46 FR 52334, Oct. 27, (27) Lormetazepam ...... 2774 (28) Mebutamate ...... 2800 1981; 51 FR 5320, Feb. 13, 1986; 52 FR 2222, Jan. (29) Medazepam ...... 2836 21, 1987; 52 FR 5952, Feb. 27, 1987; 56 FR 5754, (30) Meprobamate ...... 2820 Feb. 13, 1991; 56 FR 11932, Mar. 21, 1991; 62 FR (31) Methohexital ...... 2264 13968, Mar. 24, 1997; 64 FR 35930, July 2, 1999; (32) Methylphenobarbital (mephobarbital) ...... 2250 64 FR 37675, July 13, 1999; 65 FR 13238, Mar. (33) Midazolam ...... 2884 13, 2000; 65 FR 17440, Apr. 3, 2000] (34) Nimetazepam ...... 2837 (35) Nitrazepam ...... 2834 (36) Nordiazepam ...... 2838 § 1308.14 Schedule IV. (37) Oxazepam ...... 2835 (a) Schedule IV shall consist of the (38) Oxazolam ...... 2839 (39) Paraldehyde ...... 2585 drugs and other substances, by what- (40) Petrichloral ...... 2591 ever official name, common or usual (41) Phenobarbital ...... 2285 name, chemical name, or brand name (42) Pinazepam ...... 2883 (43) Prazepam ...... 2764 designated, listed in this section. Each (44) Quazepam ...... 2881 drug or substance has been assigned (45) Temazepam ...... 2925 the DEA Controlled Substances Code (46) Tetrazepam ...... 2886 (47) Triazolam ...... 2887 Number set forth opposite it. (48) Zaleplon ...... 2781 (b) Narcotic drugs. Unless specifically (49) Zolpidem ...... 2783 excepted or unless listed in another (d) Fenfluramine. Any material, com- schedule, any material, compound, pound, mixture, or preparation which mixture, or preparation containing any contains any quantity of the following of the following narcotic drugs, or substances, including its salts, isomers their salts calculated as the free anhy- (whether optical, position, or geo- drous base or alkaloid, in limited quan- metric), and salts of such isomers, tities as set forth below: whenever the existence of such salts, (1) Not more than 1 milligram of difenoxin and not less isomers, and salts of isomers is pos- than 25 micrograms of atropine sulfate per dosage unit ...... 9167 sible: (2) Dextropropoxyphene (alpha-(∂)-4-dimethylamino- (1) Fenfluramine ...... 1670 1,2-diphenyl-3-methyl-2-propionoxybutane) ...... 9278 (e) Stimulants. Unless specifically ex- (c) Depressants. Unless specifically cepted or unless listed in another excepted or unless listed in another schedule, any material, compound, schedule, any material, compound, mixture, or preparation which contains mixture, or preparation which contains any quantity of the following sub- any quantity of the following sub- stances having a stimulant effect on stances, including its salts, isomers, the central nervous system, including and salts of isomers whenever the ex- its salts, isomers and salts of isomers: istence of such salts, isomers, and salts (1) Cathine ((∂)-norpseudoephedrine) ...... 1230 of isomers is possible within the spe- (2) Diethylpropion ...... 1610 cific chemical designation: (3) Fencamfamin ...... 1760 (4) Fenproporex ...... 1575 (1) Alprazolam ...... 2882 (5) Mazindol ...... 1605 (2) Barbital ...... 2145 (6) Mefenorex ...... 1580 (3) Bromazepam ...... 2748 (7)Modafinil ...... 1680 (4) Camazepam ...... 2749 (8) Pemoline (including organometallic complexes and (5) Chloral betaine ...... 2460 chelates thereof) ...... 1530 (6) Chloral hydrate ...... 2465 (9) Phentermine ...... 1640 (7) Chlordiazepoxide ...... 2744 (10) Pipradrol ...... 1750 (8) Clobazam ...... 2751 (11) Sibutramine ...... 1675 (9) Clonazepam ...... 2737 (12) SPA ((-)-1-dimethylamino- 1,2-diphenylethane) .... 1635 (10) Clorazepate ...... 2768 (11) Clotiazepam ...... 2752 (f) Other substances. Unless specifi- (12) Cloxazolam ...... 2753 cally excepted or unless listed in an- (13) Delorazepam ...... 2754 (14) Diazepam ...... 2765 other schedule, any material, com- (15) Estazolam ...... 2756 pound, mixture or preparation which (16) Ethchlorvynol ...... 2540 contains any quantity of the following (17) Ethinamate ...... 2545 (18) Ethyl loflazepate ...... 2758 substances, including its salts: (19) Fludiazepam ...... 2759 (1) Pentazocine ...... 9709 (20) Flunitrazepam ...... 2763 (2) Butorphanol (including its optical isomers) ...... 9720 (21) Flurazepam ...... 2767 (22) Halazepam ...... 2762 [39 FR 22143, June 20, 1974] 87
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EDITORIAL NOTE: For FEDERAL REGISTER ci- on the central nervous system, includ- tations affecting § 1308.14, see the List of CFR ing its salts, isomers and salts of iso- Sections Affected, which appears in the mers: Finding Aids section of the printed volume and on GPO Access. (1) Pyrovalerone ...... 1485. (2) [Reserved] § 1308.15 Schedule V. [39 FR 22143, June 20, 1974, as amended at 43 (a) Schedule V shall consist of the FR 38383, Aug. 28, 1978; 44 FR 40888, July 13, drugs and other substances, by what- 1979; 47 FR 49841, Nov. 3, 1982; 50 FR 8108, Feb. ever official name, common or usual 28, 1985; 52 FR 5952, Feb. 27, 1987; 53 FR 10870, name, chemical name, or brand name Apr. 4, 1988; 56 FR 61372, Dec. 3, 1991] designated, listed in this section. (b) Narcotic drugs. Unless specifically EXCLUDED NONNARCOTIC SUBSTANCES excepted or unless listed in another § 1308.21 Application for exclusion of a schedule, any material, compound, nonnarcotic substance. mixture, or preparation containing any of the following narcotic drugs and (a) Any person seeking to have any their salts, as set forth below: nonnarcotic substance which may, under the Federal Food, Drug, and Cos- (1) Buprenorphine ...... 9064 metic Act (21 U.S.C. 301), be lawfully (c) Narcotic drugs containing non-nar- sold over the counter without a pre- cotic active medicinal ingredients. Any scription, excluded from any schedule, compound, mixture, or preparation pursuant to section 201(g) (1) of the Act containing any of the following nar- (21 U.S.C. 811 (g) (1)), may apply to the cotic drugs, or their salts calculated as Administrator, Drug Enforcement Ad- the free anhydrous base or alkaloid, in ministration, Department of Justice, limited quantities as set forth below, Washington, DC 20537. which shall include one or more non- (b) An application for an exclusion narcotic active medicinal ingredients under this section shall contain the fol- in sufficient proportion to confer upon lowing information: the compound, mixture, or preparation (1) The name and address of the ap- valuable medicinal qualities other than plicant; those possessed by narcotic drugs (2) The name of the substance for alone: which exclusion is sought; and (1) Not more than 200 milligrams of (3) The complete quantitative com- codeine per 100 milliliters or per 100 position of the substance. grams. (c) Within a reasonable period of (2) Not more than 100 milligrams of time after the receipt of an application dihydrocodeine per 100 milliliters or for an exclusion under this section, the per 100 grams. Administrator shall notify the appli- (3) Not more than 100 milligrams of cant of his acceptance or nonaccept- ethylmorphine per 100 milliliters or per ance of his application, and if not ac- 100 grams. cepted, the reason therefore. The Ad- (4) Not more than 2.5 milligrams of ministrator need not accept an applica- diphenoxylate and not less than 25 tion for filing if any of the require- micrograms of atropine sulfate per dos- ments prescribed in paragraph (b) of age unit. this section is lacking or is not set (5) Not more than 100 milligrams of forth as to be readily understood. If the opium per 100 milliliters or per 100 applicant desires, he may amend the grams. application to meet the requirements (6) Not more than 0.5 milligram of of paragraph (b) of this section. If the difenoxin and not less than 25 application is accepted for filing, the micrograms of atropine sulfate per dos- Administrator shall issue and publish age unit. in the FEDERAL REGISTER his order on (d) Stimulants. Unless specifically ex- the application, which shall include a empted or excluded or unless listed in reference to the legal authority under another schedule, any material, com- which the order is issued and the find- pound, mixture, or preparation which ings of fact and conclusions of law contains any quantity of the following upon which the order is based. This substances having a stimulant effect order shall specify the date on which it
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