[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1303.23]

[Page 48-49]
 
                         TITLE 21-FOOD AND DRUGS
 
   CHAPTER II--DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE
 
PART 1303_QUOTAS--Table of Contents
 
Sec. 1303.23  Procedure for fixing individual manufacturing quotas.

    (a) In fixing individual manufacturing quotas for a basic class of 
controlled substance listed in Schedule I or II, the Administrator shall 
allocate to each applicant who is currently manufacturing such class a 
quota equal to 100 percent of the estimated net disposal of that 
applicant for the next calendar year, adjusted--
    (1) By the amount necessary to increase or reduce the estimated 
inventory of the applicant on December 31 of

[[Page 49]]

the current year to his estimated inventory allowance for the next 
calendar year, pursuant to Sec. 1303.24, and
    (2) By any other factors which the Administrator deems relevant to 
the fixing of the individual manufacturing quota of the applicant, 
including the trend of (and recent changes in) his and the national 
rates of net disposal, his production cycle and current inventory 
position, the economic and physical availability of raw materials for 
use in manufacturing and for inventory purposes, yield and stability 
problems, potential disruptions to production (including possible labor 
strikes), and recent unforeseen emergencies such as floods and fires.
    (b) In fixing individual manufacturing quotas for a basic class of 
controlled substance listed in Schedule I or II, the Administrator shall 
allocate to each applicant who is not currently manufacturing such class 
a quota equal to 100 percent of the reasonably estimated net disposal of 
that applicant for the next calendar year, as determined by the 
Administrator, adjusted--
    (1) By the amount necessary to provide the applicant his estimated 
inventory allowance for the next calendar year, pursuant to Sec. 
1303.24, and
    (2) By any other factors which the Administrator deems relevant to 
the fixing of the individual manufacturing quota of the applicant, 
including the trend of (and recent changes in) the national rate of net 
disposal, his production cycle and current inventory position, the 
economic and physical availability of raw materials for use in 
manufacturing and for inventory purposes, yield and stability problems, 
potential disruptions to production (including possible labor strikes), 
and recent unforeseen emergencies such as floods and fires.
    (c) The Administrator shall, on or before March 1 of each year, 
adjust the individual manufacturing quota allocated for that year to 
each applicant in paragraph (a) of this section by the amount necessary 
to increase or reduce the actual inventory of the applicant to December 
31 of the preceding year to his estimated inventory allowance for the 
current calendar year, pursuant to Sec. 1303.24.

[36 FR 7786, Apr. 24, 1971, as amended at 37 FR 15920, Aug. 8, 1972. 
Redesignated at 38 FR 26609, Sept. 24, 1973]