[Code of Federal Regulations]
[Title 21, Volume 9]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1303.13]

[Page 45-46]
 
                         TITLE 21-FOOD AND DRUGS
 
   CHAPTER II--DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE
 
PART 1303--QUOTAS--Table of Contents
 
Sec. 1303.13  Adjustments of aggregate production quotas.

    (a) The Administrator may at any time increase or reduce the 
aggregate production quota for a basic class of controlled substance 
listed in Schedule I or II which he has previously fixed pursuant to 
Sec. 1303.11.
    (b) In determining to adjust the aggregate production quota, the 
Administrator shall consider the following factors:
    (1) Changes in the demand for that class, changes in the national 
rate of net disposal of the class, and changes in the rate of net 
disposal of the class by registrants holding individual manufacturing 
quotas for that class;

[[Page 46]]

    (2) Whether any increased demand for that class, the national and/or 
individual rates of net disposal of that class are temporary, short 
term, or long term;
    (3) Whether any increased demand for that class can be met through 
existing inventories, increased individual manufacturing quotas, or 
increased importation, without increasing the aggregate production 
quota, taking into account production delays and the probability that 
other individual manufacturing quotas may be suspended pursuant to 
Sec. 1303.24(b);
    (4) Whether any decreased demand for that class will result in 
excessive inventory accumulation by all persons registered to handle 
that class (including manufacturers, distributors, practitioners, 
importers, and exporters), notwithstanding the possibility that 
individual manufacturing quotas may be suspended pursuant to 
Sec. 1303.24(b) or abandoned pursuant to Sec. 1303.27;
    (5) Other factors affecting medical, scientific, research, and 
industrial needs in the United States and lawful export requirements, as 
the Administrator finds relevant, including changes in the currently 
accepted medical use in treatment with the class or the substances which 
are manufactured from it, 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 in the event he determines to increase or 
reduce the aggregate production quota for a basic class of controlled 
substance, shall publish in the Federal Register general notice of an 
adjustment in the aggregate production quota for that class determined 
by him under this section. A copy of said notice shall be mailed 
simultaneously to each person registered as a bulk manufacturer of the 
basic class. The Administrator shall permit any interested person to 
file written comments on or objections to the proposal and shall 
designate in the notice the time during which such filings may be made. 
The Administrator may, but shall not be required to, hold a public 
hearing on one or more issues raised by the comments and objections 
filed with him. In the event the Administrator decides to hold such a 
hearing, he shall publish notice of the hearing in the Federal Register, 
which notice shall summarize the issues to be heard and shall set the 
time for the hearing, which shall not be less than 10 days after the 
date of publication of the notice. After consideration of any comments 
or objections, or after a hearing if one is ordered by the 
Administrator, the Administrator shall issue and publish in the Federal 
Register his final order determining the aggregate production for the 
basic class of controlled substance. The order shall include the 
findings of fact and conclusions of law upon which the order is based. 
The order shall specify the date on which it shall take effect. A copy 
of said order shall be mailed simultaneously to each person registered 
as a bulk manufacturer of the basic class.

[37 FR 15919, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973]

                     Individual Manufacturing Quotas