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CFR › Title 21 › Chapter II › Part 1301 › Section 1301.33

21 CFR 1301.33 - Application for bulk manufacture of Schedule I and II substances.

§ 1301.33
Application for bulk manufacture of Schedule I and II substances.
(a) In the case of an application for registration or reregistration to manufacture in bulk a basic class of controlled substance listed in Schedule I or II, the Administrator shall, upon the filing of such application, publish in the Federal Register a notice naming the applicant and stating that such applicant has applied to be registered as a bulk manufacturer of a basic class of narcotic or nonnarcotic controlled substance, which class shall be identified. A copy of said notice shall be mailed simultaneously to each person registered as a bulk manufacturer of that basic class and to any other applicant therefor. Any such person may, within 60 days from the date of publication of the notice in the Federal Register, file with the Administrator written comments on or objections to the issuance of the proposed registration.
(b) In order to provide adequate competition, the Administrator shall not be required to limit the number of manufacturers in any basic class to a number less than that consistent with maintenance of effective controls against diversion solely because a smaller number is capable of producing an adequate and uninterrupted supply.
(c) This section shall not apply to the manufacture of basic classes of controlled substances listed in Schedules I or II as an incident to research or chemical analysis as authorized in § 1301.13(e)(1).
[62 FR 13953, Mar. 24, 1997]

Title 21 published on 2012-04-01

no entries appear in the Federal Register after this date.

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.

United States Code
USC : Title 21 - FOOD AND DRUGS

§ 821 - Rules and regulations

§ 822 - Persons required to register

§ 823 - Registration requirements

§ 824 - Denial, revocation, or suspension of registration

§ 871 - Attorney General

§ 875 - Administrative hearings

§ 877 - Judicial review

§ 886a - Diversion Control Fee Account

§ 951 - Definitions

§ 952 - Importation of controlled substances

§ 953 - Exportation of controlled substances

§ 956 - Exemption authority

§ 957 - Persons required to register

§ 958 - Registration requirements

Title 21 published on 2012-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 1301 after this date.

  • 2012-12-21; vol. 77 # 246 - Friday, December 21, 2012
    1. 77 FR 75784 - Disposal of Controlled Substances
      GPO FDSys XML | Text
      DEPARTMENT OF JUSTICE, Drug Enforcement Administration
      Notice of proposed rulemaking.
      Electronic comments must be submitted and written comments must be postmarked on or before February 19, 2013. Commenters should be aware that the electronic Federal Docket Management System will not accept comments after midnight Eastern Time on the last day of the comment period.
      21 CFR Parts 1300, 1301, 1304, 1305, 1307, 1317, and 1321