[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: 21CFR1303.22]

[Page 47-48]
 
                         TITLE 21-FOOD AND DRUGS
 
   CHAPTER II--DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE
 
PART 1303--QUOTAS--Table of Contents
 
Sec. 1303.22  Procedure for applying for individual manufacturing quotas.

    Any person who is registered to manufacture any basic class of 
controlled substance listed in Schedule I or II and who desires to 
manufacture a quantity of such class shall apply on DEA Form 189 for a 
manufacturing quota for such quantity of such class. Copies of DEA Form 
189 may be obtained from, and shall be filed (on or before May 1 of the 
year preceding the calendar year for which the manufacturing quota is 
being applied) with, the Drug & Chemical Evaluation Section, Drug 
Enforcement Administration, Department of Justice, Washington, D.C. 
20537. A separate application must be made for each basic class desired 
to be manufactured. The applicant shall state:
    (a) The name and Administration Controlled Substances Code Number, 
as set forth in part 1308 of this chapter, of the basic class.
    (b) For the basic class in each of the current and preceding 2 
calendar years,
    (1) The authorized individual manufacturing quota, if any;
    (2) The actual or estimated quantity manufactured;
    (3) The actual or estimated net disposal;
    (4) The actual or estimated inventory allowance pursuant to 
Sec. 1303.24; and
    (5) The actual or estimated inventory as of December 31;
    (c) For the basic class in the next calendar year,
    (1) The desired individual manufacturing quota; and
    (2) Any additional factors which the applicant finds relevant to the 
fixing of his individual manufacturing quota, including the trend of 
(and recent changes in) his and the national rates of net disposal, his 
production cycle and current inventory position, the econolic and 
physical availability of raw materials for use in manufacturing and for 
inventory purposes, yield and stability problems, potential disruptions 
to production (including possible

[[Page 48]]

labor strikes) and recent unforeseen emergencies such as floods and 
fires.

[36 FR 7786, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971; 37 
FR 15920, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973, and 
amended at 46 FR 28841, May 29, 1981; 51 FR 5319, Feb. 13, 1986; 62 FR 
13958, Mar. 24, 1997]