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Drug Enforcement Administration, Justice § 1308.15

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 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) ((+)-norpseudoephedrine) ...... 1230 (3) Not more than 100 milligrams of (2) Diethylpropion ...... 1610 (3) Fencamfamin ...... 1760 ethylmorphine per 100 milliliters or per (4) ...... 1575 100 grams. (5) ...... 1605 (6) ...... 1580 (4) Not more than 2.5 milligrams of (7) ...... 1680 diphenoxylate and not less than 25 (8) (including organometallic complexes and micrograms of atropine sulfate per dos- chelates thereof) ...... 1530 (9) ...... 1640 age unit. (10) ...... 1750 (5) Not more than 100 milligrams of (11) ...... 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) . 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) ...... 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 depressant 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) Pregabalin [(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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EXCLUDED NONNARCOTIC SUBSTANCES the application, which shall include a reference to the legal authority under § 1308.21 Application for exclusion of a which the order is issued and the find- nonnarcotic substance. ings of fact and conclusions of law (a) Any person seeking to have any upon which the order is based. This nonnarcotic drug that may, under the order shall specify the date on which it Federal Food, Drug, and Cosmetic Act shall take effect. The Administrator (21 U.S.C. 301), be lawfully sold over the shall permit any interested person to counter without a prescription, ex- file written comments on or objections cluded from any schedule, pursuant to to the order within 60 days of the date section 201(g)(1) of the Act (21 U.S.C. of publication of his order in the FED- 811(g)(1)), may apply to the Office of ERAL REGISTER. If any such comments Diversion Control, Drug Enforcement or objections raise significant issues Administration. See the Table of DEA regarding any finding of fact or conclu- Mailing Addresses in § 1321.01 of this sion of law upon which the order is chapter for the current mailing ad- based, the Administrator shall imme- dress. diately suspend the effectiveness of the (b) An application for an exclusion order until he may reconsider the ap- under this section shall contain the fol- plication in light of the comments and lowing information: objections filed. Thereafter, the Ad- (1) The name and address of the ap- ministrator shall reinstate, revoke, or plicant; amend his original order as he deter- (2) The name of the substance for mines appropriate. which exclusion is sought; and (d) The Administrator may at any (3) The complete quantitative com- time revoke any exclusion granted pur- position of the substance. suant to section 201(g) of the Act (21 (c) Within a reasonable period of U.S.C. 811(g)) by following the proce- time after the receipt of an application dures set forth in paragraph (c) of this for an exclusion under this section, the section for handling an application for Administrator shall notify the appli- an exclusion which has been accepted cant of his acceptance or nonaccept- for filing. ance of his application, and if not ac- cepted, the reason therefore. The Ad- [38 FR 8254, Mar. 30, 1973, as amended at 70 ministrator need not accept an applica- FR 74657, Dec. 16, 2005; 75 FR 10678, Mar. 9, tion for filing if any of the require- 2010] ments prescribed in paragraph (b) of this section is lacking or is not set § 1308.22 Excluded substances. forth as to be readily understood. If the The following nonnarcotic substances applicant desires, he may amend the which may, under the Federal Food, application to meet the requirements Drug, and Cosmetic Act (21 U.S.C. 301), of paragraph (b) of this section. If the be lawfully sold over the counter with- application is accepted for filing, the out a prescription, are excluded from Administrator shall issue and publish all schedules pursuant to section 201(g) in the FEDERAL REGISTER his order on (1) of the Act (21 U.S.C. 811(g) (1)):

EXCLUDED NONNARCOTIC PRODUCTS

(mg or mg/ Company Trade name NDC code Form Controlled substance ml)

Bioline Laboratories ...... Theophed ...... 00719–1945 TB Phenobarbital ...... 8.00 Classic Pharmaceuticals Nasal Decongestant In- IN Levmetamfetamine (l-Des- 50.00 LLC. haler/Vapor Inhaler. oxyephedrine). Goldline Laboratories ...... Guiaphed Elixir ...... 00182–1377 EL Phenobarbital ...... 4.00 Goldline Laboratories ...... Tedrigen Tablets ...... 00182–0134 TB Phenobarbital ...... 8.00 Hawthorne Products Inc .... Choate’s Leg Freeze ...... LQ Chloral hydrate ...... 246.67 Parke-Davis & Co ...... Tedral ...... 00071–0230 TB Phenobarbital ...... 8.00 Parke-Davis & Co ...... Tedral Elixir ...... 00071–0242 EX Phenobarbital ...... 40.00 Parke-Davis & Co ...... Tedral S.A...... 00071–0231 TB Phenobarbital ...... 8.00 Parke-Davis & Co ...... Tedral Suspension ...... 00071–0237 SU Phenobarbital ...... 80.00 Parmed Pharmacy ...... Asma-Ese ...... 00349–2018 TB Phenobarbital ...... 8.10 Rondex Labs ...... Azma-Aids ...... 00367–3153 TB Phenobarbital ...... 8.00 Smith Kline Consumer ...... Benzedrex ...... 49692–0928 IN ...... 250.00 Sterling Drug, Inc ...... Bronkolixir ...... 00057–1004 EL Phenobarbital ...... 0.80

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