[Code of Federal Regulations]
[Title 21, Volume 9]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1301.33]

[Page 26-27]
 
                         TITLE 21-FOOD AND DRUGS
 
   CHAPTER II--DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE
 
PART 1301--REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCES--Table of Contents
 
Sec. 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

[[Page 27]]

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 Sec. 1301.13(e)(1).

[62 FR 13953, Mar. 24, 1997]