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(2) Any salt, compound, derivative, or preparation thereof which is chemically equivalent or identical with any of the substances referred to in subparagraph (1) of this paragraph, except that these substances shall not include the isoquinoline alkaloids of opium.

(3) Opium poppy and poppy straw.

(4) Coca leaves (9040) and any salt, compound, derivative, or preparation of coca leaves, and any salt, compound, derivative, or preparation thereof which is chemically equivalent or identical with any of these substances, except that the substances shall not include decocainized coca leaves or extraction of coca leaves, which extractions do not contain cocaine (9041) or ecgonine (9180).

(c) Opiates. Unless specifically excepted or unless in another schedule any of the following opiates, including its isomers, esters, ethers, salts and salts of isomers, esters and ethers whenever the existence of such isomers, esters, ethers, and salts is possible within the specific chemical designation:

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(21) Racemorphan

(d) 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 system:

(1) Amphetamine, its salts, optical isomers, and salts of its optical isomers

(2) Methamphetamine, its salts, iso

1, 100

mers, and salts of its isomers___ 1, 105 (3) Phenmetrazine and its salts------ 1, 630 (4) Methylphenidate__

1, 726 [36 F.R. 7802, Apr. 24, 1971, as amended at 36 F.R. 12735, July 7, 1971; 36 F.R. 19116, Sept. 29, 1971; 36 F.R. 20686, Oct. 28, 1971]

§ 308.13 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 Bureau 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 system:

(1) Those compounds, mixtures, or preparations in dosage unit form containing any stimulant substances which compounds, mixtures, or preparations were listed on August 25, 1971, as excepted compounds under § 308.32, 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.

(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 de

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(e) Narcotics drugs. Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation containing limited quantities of any of the following narcotic drugs, or any salts thereof: (1) Not more than 1.8

grams of

codeine per 100 milliliters or not more than 90 milligrams per dosage unit, with an equal or greater quantity of an isoquinoline alkaloid of opium--. (2) Not more than 1.8 grams of codeine per 100 milliliters or not more than 90 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts

(3) Not more than 300 milligrams of dihydrocodeinone per 100 milliliters or not more than 15 milligrams per dosage unit, with a fourfold or greater quantity of an isoquinoline alkaloid of opium

(4) Not more than 300 milligrams of dihydrocodeinone per 100 milliliters or not more than 15 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts___

(5) Not more than 1.8 grams of dihydrocodeine per 100 milliliters or not more than 90 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts_.

(6) Not more than 300 milligrams of ethylmorphine per 100 milliliters or not more than 15 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts__.

9803

9804

9805

9806

9807

9808

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[36 F.R. 7802, Apr. 24, 1971, as amended at 36 F.R. 12735, July 7, 1971; 36 F.R. 13387, July 21, 1971; 36 F.R. 20687, Oct. 28, 1971; 36 F.R. 21336, Nov. 6, 1971; 36 F.R. 22153, Nov. 20, 1971]

§ 308.14 Schedule IV.

(a) Schedule IV 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 Bureau Controlled Substances Code Number set forth opposite it.

(b) Depressants. Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances, including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation:

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nonnarcotic active medicinal ingredients in sufficient proportion to confer upon the compound, mixture, or preparation valuable medicinal qualities other than those possessed by the narcotic drug alone:

(1) Not more than 200 milligrams of codeine per 100 milliliters or per 100 grams.

(2) Nor more than 100 milligrams of dihydrocodeine per 100 milliliters or per 100 grams.

(3) Not more than 100 milligrams of ethylmorphine per 100 milliliters or per 100 grams.

(4) Not more than 2.5 milligrams of diphenoxylate and not less than 25 micrograms of atropine sulfate per dosage unit.

(5) Not more than 100 milligrams of opium per 100 milliliters or per 100 grams. [36 F.R. 7802, Apr. 24, 1971, as amended at 36 F.R. 13387, July 21, 1971]

EXCLUDED NONNARCOTIC SUBSTANCES § 308.21

Application for exclusion of a nonnarcotic substance.

(a) Any person seeking to have any nonnarcotic substance which may, under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301), be lawfully sold over the counter without a prescription, excluded from any schedule, pursuant to section 201(g) (1) of the Act (21 U.S.C. 811(g) (1)), may apply to the Director, Bureau of Narcotics and Dangerous Drugs, Department of Justice, Washington, D.C. 20537.

(b) An application for an exclusion under this section shall contain the following information:

(1) The name and address of the applicant;

(2) The name of the substance for which exclusion is sought; and

(3) The complete quantitative composition of the substance.

(c) Within a reasonable period of time after the receipt of an application for an exclusion under this section, the Director shall notify the applicant of his acceptance or nonacceptance of the application, and if not accepted, the reason therefor. The Director need not accept an application for filing if any of the requirements prescribed in paragraph (b) of this section is lacking or is not set forth so as to be readily understood. If the applicant

desires, he may amend the application to meet the requirements of paragraph (b) of this section. If accepted for filing, the Director shall publish in the FEDERAL REGISTER general notice of his proposed rule making in granting or denying the application. Such notice shall include a reference to the legal authority under which the rule is proposed, a statement of the proposed rule granting or an exclusion, or denying an exclusion when he finds that the substance may not, under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 821), lawfully be sold over-the-counter without a prescription, or that the substance is not nonnarcotic, and, in the discretion of the Director, a summary of the subjects and issues involved. The Director shall permit any interested person to file written comments on or objections to the proposal and shall designate in the notice of proposed rule making the time during which such filings may be made. After consideration of the application and any comments on or objections to his proposed rule making, the Director shall issue and publish in the FEDERAL REGISTER his final order on the application, which shall set forth the findings of fact and conclusions of law upon which the order is based. This order shall specify the date on which it shall take effect, which shall not be less than 30 days from the date of publication in the FEDERAL REGISTER UNless the Director finds that conditions of public health or safety necessitate an earlier effective date, in which event the Director shall specify in the order his findings as to such conditions.

(d) The Director may at any time revoke any exclusion granted pursuant to section 201(g) of the Act (21 U.S.C. 811 (g)) by following the procedures set forth in paragraph (c) of this section for handling an application for an exclusion which has been accepted for filing.

[36 F.R. 7802, Apr. 24, 1971, as amended at 36 F.R. 18733, 18734, Sept. 21, 1971] § 308.22 Excluded substances.

The following nonnarcotic substances which may, under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301), be lawfully sold over the counter without a prescription, are excluded from all schedules pursuant to section 201(g) (1) of the Act (21 U.S.C. 811(g)(1)):

Trade name or other designation

Amodrine.

Bronkaid.

Bronkolixir..

Bronkotabs...

Beckman Buffer B-1..

Beckman Buffer B-2................

Primatene. Tedral..

Tedral Anti-H.

Tedral one-half strength... ---
Tedral Pediatric Suspension...
Tedral suppositories double
strength.

Tedral suppositories regular
strength.
Verequad

Verequad...

EXEMPTED OVER-THE-COUNTER DRUGS

Composition

Tablet: Phenobarbital, 8 mg.; aminophylline, 100
mg.; racephedrine hydrochloride, 25 mg.
Tablet: Phenobarbital, 8 mg.; ephedrine sulfate, 24
mg.; glyceryl guaiacolate, 100 mg.; theophylline,
100 mg.; thenyldiamine, 10 mg.

Manufacturer or supplier

G. D. Searle & Co.

Drew Pharmacal Co., Inc.

Do.

Spinco Division, Beckman Instruments, Inc.

Elixir (5 cc): Phenobarbital, 4 mg.; ephedrine sulfate, Breon Laboratories Inc. 12 mg.; glyceryl guaiacolate, 50 mg.; theophylline, 15 mg.; chlorpheniramine maleate, 1 mg. Tablet: Phenobarbital, 8 mg.; ephedrine sulfate, 24 mg.; glyceryl guaiacolate, 100 mg.; theophylline, 100 mg.; thenyldiamine, 10 mg. Packet: Diethyl Barbituric Acid, 1.84 gm.; sodium diethyl barbiturate, 10.30 gm. (for use with Beckman Model R paper electrophoresis system). Packet: Diethyl Barbituric Acid, 2.76 gm.; sodium diethyl barbiturate, 15.40 gm. (for use with Beckman Model R paper electrophoresis system). Tablet: Phenobarbital, % gr.; ephedrine, 3% gr. Tablet: Phenobarbital, 8 mg.; theophylline, 130 mg.; ephedrine hydrochloride, 24 mg.

Tablet: Phenobarbital, 8 mg.; chlorpheniramine maleate, 2 mg.; theophylline, 130 mg.; ephedrine hydrochloride, 24 mg.

Tablet: Phenobarbital, 4 mg.; theophylline, 65 mg.; ephedrine hydrochloride, 12 mg.

Suspension (5 cc): Phenobarbital, 4 mg.; ephedrine hydrochloride, 12 mg.; theophylline, 65 mg. Suppository: Phenobarbital, 16 mg.; theophylline, 260 mg.; ephedrine hydrochloride, 48 mg. Suppository: Phenobarbital, 8 mg.; theophylline, 130 mg.; ephedrine hydrochloride, 24 mg.

Do.

Whitehall Laboratories. Warner-Chilcott Laboratories.

Do.

Do.

Do.

Do.

Do.

Tablet: Phenobarbital, 8 mg.; theophylline calcium Knoll Pharmaceutical Co. salicylate, 130 mg.; ephedrine hydrochloride, 24 mg.; glyceryl guaiacolate, 100 mg.

Suspension (5 cc): Phenobarbital, 4 mg.; theophylline calcium salicylate, 65 mg.; ephedrine hydrochloride, 12 mg.; glyceryl guaiacolate, 50 mg.

EXCEPTED STIMULANT OR DEPRESSANT COMPOUNDS

§ 308.31 Application for exception of a stimulant or depressant compound.

(a) Any person seeking to have any compound, mixture, or preparation containing any depressant or stimulant substance listed in § 308.13 (b) or (c), or in § 308.14, or in § 308.15, excepted from the application of all or any part of the Act, pursuant to section 202(d) of the Act (21 U.S.C. 812(d)), may apply to the Director, Bureau of Narcotics and Dangerous Drugs, Department of Justice, Washington, D.C. 20537, for such exception.

(b) An application for an exception under this section shall contain the following information:

(1) The complete quantitative composition of the dosage form.

(2) Description of the unit dosage form together with complete labeling.

(3) A summary of the pharmacology of the product including animal investigations and clinical evaluations and studies, with emphasis on the psychic and/or physiological dependence liability (this must be done for each of the active

Do.

ingredients separately and for the combination product).

(4) Details of synergisms and antagonisms among ingredients.

(5) Deterrent effects of the noncontrolled ingredients.

(6) Complete copies of all literature in support of claims.

(7) Reported instances of abuse.

(8) Reported and anticipated adverse effects.

(9) Number of dosage units produced for the past 2 years.

(c) Within a reasonable period of time after the receipt of an application for an exception under this section, the Director shall notify the applicant of his acceptance or nonacceptance of the application, and if not accepted, the reason therefor. The Director reed not accept an application for filing if any of the requirements prescribed in paragraph (b) of this section is lacking or is not set forth so as to be readily understood. If the applicant desires, he may amend the application to meet the requirements of paragraph (b) of this section. If accepted for filing, the Director shall publish in the FEDERAL REGISTER general notice of his proposed rule making in

granting or denying the application. Such notice shall include a reference to the legal authority under which the rule is proposed, a statement of the proposed rule granting or denying an exception, and, in the discretion of the Director, a summary of the subjects and issues involved. The Director shall permit any interested person to file written comments on or objections to the proposal and shall designate in the notice of proposed rule making the time during which such filings may be made. After consideration of the application and any comments on or objections to his proposed rule making, the Director shall issue and publish in the FEDERAL REGISTER his final order on the application, which shall set forth the findings of fact and conclusions of law upon which the order is based. This order shall specify the date on which it shall take effect, which shall not be less than 30 days from the date of publication in the FEDERAL REGISTER unless the Director finds that conditions of public health or safety necessitate an earlier effective date, in which event the Director shall specify in the order his findings as to such conditions.

(d) The Director may at any time revoke any exception granted pursuant to section 202(d) of the Act (21 U.S.C. 812 (d)) by following the procedures set forth in paragraph (c) of this section for handling an application for an exception which has been accepted for filing.

[36 F.R. 7802, Apr. 24, 1971; 36 F.R. 13387, July 21, 1971, as amended at 36 F.R. 18734, Sept. 21, 1971]

Trade name or other designation

§ 308.32 Excepted compounds.

(a) Until criteria are adopted by the Bureau by which the Director may determine whether to except any compound, mixture, or preparation containing any depressant or stimulant substance listed in § 308.13 (b) or (c), or in § 308.14, or in § 308.15, from the application of all or any part of the Act pursuant to section 202(d) of the Act (21 U.S.C. 812(d)), the drugs set forth in paragraph (b) of this section have been excepted by the Director from application of the sections 305, 307, 308, 309, 1002, 1003, and 1004 of the Act (21 U.S.C. 825, 827-9, 952-4) and of § 301.74(d) of this chapter for administrative purposes only. The excepting of these drugs by the Director should not be construed as an adoption or rejection of the criteria by which these drugs were originally excepted. Any deviation from the quantitative composition of any of the listed drugs shall require a petition for exception in order for that drug to be excepted.

(b) The following drugs in dosage unit form, and any other drug of the quantitative composition shown below for one of the following drugs or which is the same except that it contains a lesser quantity of controlled substances or other substances which do not have a stimulant, depressant, or hallucinogenic effect, and which are restricted by law to dispensing on prescription, are excepted from the application of sections 305, 307, 308, 309, 1002, 1003, and 1004 of the Act (21 U.S.C. 825, 827-9, 952-4) and of § 301.74 (d) of this chapter:

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A.E.A. Alased

Alcitex.

Algoson.. Alhydrox..

Alkasans

Alsical..

Alubelap...

Aludrox SA Suspension....

Norgine Laboratories, Inc.

Tablet: Amobarbital, 25 mg.; aminophylline, 120 Haack Laboratories, Inc. mg.; ephedrine hydrochloride, 25 mg. Tablet: Phenobarbital, 16.2 mg.; homatropine methylbromide, 3.6 mg.; aluminum hydroxide gel, dried, 721⁄2 gr.: magnesium trisilicate, 21⁄2 gr. Tablet: Phenobarbital, g gr.; atropine sulfate, 5000 Paul B. Elder Co., Inc. gr.; calcium carbonate, 31⁄2 gr.; magnesium carbonate, 21⁄2 gr.; cerium oxalate, 1⁄2 gr.

Tablet: Butabarbital sodium, 7.5 mg.; acetaminophen, 300 mg.

Tablet: Phenobarbital, % gr.; aluminum hydroxide,
5 gr.; atropine sulfate, 1300 gr.

Tablet: Phenobarbital. 8.0 mg.; atropine sulfate,
0.06 mg.; kaolin-alumina gel, 500 mg.
Powder (60 gr.): Phenobarbital, 4 gr.; belladonna
extract, gr.; calcium carbonate, 24 gr.; magne-
sium trisilicate, 15 gr.; magnesium oxide, 10 gr.;
aluminum hydroxide gel, dried, 10 gr.
Tablet: Phenobarbital, 8 mg.; aluminum hydroxide
gel, dried, 300 mg.; belladonna extract, 4 mg.
Suspension (5 cc.): Butabarbital, 8 mg.; ambu-
tonium bromide, 2.5 mg.

McNeil Laboratories Inc.

Physicians Supply.

P. J. Noyes Co. Dorsey Laboratories.

Haack Laboratories, Inc. Wyeth Laboratories.

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