Page images
PDF
EPUB

Title 21-Food and Drugs

(This book contains Part 300 to End)

Part

CHAPTER II-Bureau of Narcotics and Dangerous Drugs, Department of
Justice.

301

CROSS REFERENCES: Bureau of Customs, Department of the Treasury: See Customs Duties, 19 CFR Chapter I.

Regulations of the Public Health Service, Department of Health, Education, and Welfare, applying to narcotic addicts: See Public Health, 42 CFR Part 33.

NOTE: Other regulations issued by the Department of Justice appear in Title 4, Title 8, Title 28.

CHAPTER II-BUREAU OF NARCOTICS

AND DANGEROUS DRUGS,

DEPARTMENT OF JUSTICE

Registration of manufacturers, distributors, and dispensers of controlled sub

stances.

Labeling and packaging requirements for controlled substances.

[blocks in formation]

301

302

303

304

305

Order forms.

[blocks in formation]

Quotas.

Records and reports of registrants.

Miscellaneous.

308 Schedules of controlled substances.

309-310 [Reserved]

311 Registration of importers and exporters of controlled substances.

312 Importation and exportation of controlled substances.

[blocks in formation]
[blocks in formation]
[blocks in formation]

As used in this part, the following terms shall have the meanings specified:

(a) The term "Act" means the Controlled Substances Act (84 Stat. 1242; 21 U.S.C. 801) and/or the Controlled Substances Import and Export Act (84 Stat. 1285; 21 U.S.C. 951).

(b) The term "basic class" means, as to controlled substances listed in schedules I and II:

(1) each of the 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, listed in § 308.11 (b) of this chapter;

(2) Each of the opium derivatives, 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, listed in § 308.11(c) of this chapter;

(3) Each of the hallucinogenic 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, listed in § 308.11(d) of this chapter;

(4) Each of the following substances, whether produced directly or indirectly by extraction from substances of vegetable origin, or independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis:

(i) Opium, including raw opium, opium extracts, opium fluid extracts, powdered opium, granulated opium, deodorized opium and tincture of opium: (ii) Apomorphine;

(iii) Codeine;
(iv) Ethylmorphine;
(v) Hydrocodone;
(vi) Hydromorphone;
(vii) Metopon;
(viii) Morphine;
(ix) Oxycodone;

(x) Oxymorphone;

(xi) Thebaine;

(xii) Mixed alkaloids of opium listed in § 308.12 (b) (2) of this chapter; (xiii) Cocaine; and

(xiv) Ecgonine;

(5) Each of the 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, listed in § 308.12 (c) of this chapter; and

(6) Methamphetamine, its salts, isomers, and salts of its isomers.

(7) Amphetamine, its salts, optical isomers, and salts of its optical isomers. (8) Phenmetrazine and its salts. (9) Methylphenidate.

(c) The term "Bureau" means the Bureau of Narcotics and Dangerous Drugs.

(d) The term "Director" means the Director of the Bureau. The Director has been delegated authority under the Act by the Attorney General (28 CFR 0.100).

(e) The term "hearing" means any hearing held pursuant to this part for the granting, denial, revocation, or suspension of a registration pursuant to sections 303 and 304 of the Act (21 U.S.C. 823-824).

(f) The term "person" includes any individual, corporation, government or governmental subdivision or agency, business trust, partnership, association, or other legal entity.

(g) The terms "register" and "registration" refer only to registration required and permitted by section 303 of the Act (21 U.S.C. 823).

(h) The term "registrant” means any person who is registered pursuant to either section 303 or section 1008 of the Act (21 U.S.C. 823 or 958).

(i) Any term not defined in this section shall have the definition set forth in section 102 of the Act (21 U.S.C. 802). [36 F.R. 7778, Apr. 24, 1971, as amended at 36 F.R. 12735, July 7, 1971; 36 F.R. 20687, Oct. 28, 1971]

§ 301.03 Information; special instructions.

Information regarding procedures under these rules and instructions supplementing these rules will be furnished upon request by writing to the Registration Branch, Bureau of Narcotics and Dangerous Drugs, Department of Justice, Post Office Box 28083, Central Station, Washington, D.C. 20005.

FEES FOR REGISTRATION AND
REREGISTRATION

[blocks in formation]

stances, the registrant shall pay a fee of $25.

(c) For each registration or reregistration to dispense, or to conduct research or instructional activities with, controlled substances listed in schedules II through V, the registrant shall pay a fee of $5.

(d) For each registration or reregistration to conduct research or instructional activities with a controlled substance listed in schedule I, the registrant shall pay a fee of $5.

(e) For each registration or reregistration to conduct chemical analysis with controlled substances listed in any schedule, the registrant shall pay a fee of $5.

§ 301.12

Time and method of payment;

refund. Registration and reregistration fees shall be paid at the time when the application for registration or reregistration is submitted for filing. Payment should be made in the form of a personal, certified or cashier's check or money order made payable to "Bureau of Narcotics and Dangerous Drugs." Payments made in the form of stamps, foreign currency, or third party endorsed checks will not be accepted. In the event that the application is not accepted for filing or is denied, the payment shall be refunded to the applicant.

§ 301.13 Persons exempt from fee.

(a) The Director shall exempt from payment of a fee for registration or reregistration the following persons:

(1) Any official or agency of the U.S. Army, Navy, Marine Corps, Air Force, Coast Guard, Veterans' Administration or Public Health Service who or which is authorized to procure or purchase controlled substances for official use; and

(2) Any official, employee, or other civil officer or agency of the United States, of any State, or any political subdivision or agency thereof, who or which is authorized to purchase controlled substances, to obtain such substances from official stocks, to dispense or administer such substances, to conduct research, instructional activities, or chemical analysis with such substances, or any combination thereof, in the course of his or its official duties or employment.

(b) In order to claim exemption from payment of a registration or reregistration fee, the registrant shall have completed the certification on the ap

« PreviousContinue »