
From the U.S. Code Online via GPO Access
[wais.access.gpo.gov]
[Laws in effect as of January 2, 2001]
[Document not affected by Public Laws enacted between
  January 2, 2001 and January 28, 2002]
[CITE: 21USC826]

 
                        TITLE 21--FOOD AND DRUGS
 
              CHAPTER 13--DRUG ABUSE PREVENTION AND CONTROL
 
                  SUBCHAPTER I--CONTROL AND ENFORCEMENT
 
 Part C--Registration of Manufacturers, Distributors, and Dispensers of 
                          Controlled Substances
 
Sec. 826. Production quotas for controlled substances


(a) Establishment of total annual needs

    The Attorney General shall determine the total quantity and 
establish production quotas for each basic class of controlled substance 
in schedules I and II to be manufactured each calendar year to provide 
for the estimated medical, scientific, research, and industrial needs of 
the United States, for lawful export requirements, and for the 
establishment and maintenance of reserve stocks. Production quotas shall 
be established in terms of quantities of each basic class of controlled 
substance and not in terms of individual pharmaceutical dosage forms 
prepared from or containing such a controlled substance.

(b) Individual production quotas; revised quotas

    The Attorney General shall limit or reduce individual production 
quotas to the extent necessary to prevent the aggregate of individual 
quotas from exceeding the amount determined necessary each year by the 
Attorney General under subsection (a) of this section. The quota of each 
registered manufacturer for each basic class of controlled substance in 
schedule I or II shall be revised in the same proportion as the 
limitation or reduction of the aggregate of the quotas. However, if any 
registrant, before the issuance of a limitation or reduction in quota, 
has manufactured in excess of his revised quota, the amount of the 
excess shall be subtracted from his quota for the following year.

(c) Manufacturing quotas for registered manufacturers

    On or before October 1 of each year, upon application therefor by a 
registered manufacturer, the Attorney General shall fix a manufacturing 
quota for the basic classes of controlled substances in schedules I and 
II that the manufacturer seeks to produce. The quota shall be subject to 
the provisions of subsections (a) and (b) of this section. In fixing 
such quotas, the Attorney General shall determine the manufacturer's 
estimated disposal, inventory, and other requirements for the calendar 
year; and, in making his determination, the Attorney General shall 
consider the manufacturer's current rate of disposal, the trend of the 
national disposal rate during the preceding calendar year, the 
manufacturer's production cycle and inventory position, the economic 
availability of raw materials, yield and stability problems, emergencies 
such as strikes and fires, and other factors.

(d) Quotas for registrants who have not manufactured controlled 
        substance during one or more preceding years

    The Attorney General shall, upon application and subject to the 
provisions of subsections (a) and (b) of this section, fix a quota for a 
basic class of controlled substance in schedule I or II for any 
registrant who has not manufactured that basic class of controlled 
substance during one or more preceding calendar years. In fixing such 
quota, the Attorney General shall take into account the registrant's 
reasonably anticipated requirements for the current year; and, in making 
his determination of such requirements, he shall consider such factors 
specified in subsection (c) of this section as may be relevant.

(e) Quota increases

    At any time during the year any registrant who has applied for or 
received a manufacturing quota for a basic class of controlled substance 
in schedule I or II may apply for an increase in that quota to meet his 
estimated disposal, inventory, and other requirements during the 
remainder of that year. In passing upon the application the Attorney 
General shall take into consideration any occurrences since the filing 
of the registrant's initial quota application that may require an 
increased manufacturing rate by the registrant during the balance of the 
year. In passing upon the application the Attorney General may also take 
into account the amount, if any, by which the determination of the 
Attorney General under subsection (a) of this section exceeds the 
aggregate of the quotas of all registrants under this section.

(f) Incidental production exception

    Notwithstanding any other provisions of this subchapter, no 
registration or quota may be required for the manufacture of such 
quantities of controlled substances in schedules I and II as 
incidentally and necessarily result from the manufacturing process used 
for the manufacture of a controlled substance with respect to which its 
manufacturer is duly registered under this subchapter. The Attorney 
General may, by regulation, prescribe restrictions on the retention and 
disposal of such incidentally produced substances.

(Pub. L. 91-513, title II, Sec. 306, Oct. 27, 1970, 84 Stat. 1257; Pub. 
L. 94-273, Sec. 3(16), Apr. 21, 1976, 90 Stat. 377.)

                       References in Text

    Schedules I and II, referred to in text, are set out in section 
812(c) of this title.


                               Amendments

    1976--Subsec. (c). Pub. L. 94-273 substituted ``October'' for 
``July''.


                             Effective Date

    Section effective on first day of seventh calendar month that begins 
after Oct. 26, 1970, but with Attorney General authorized to postpone 
such effective date for such period as he might determine to be 
necessary for the efficient administration of this subchapter, see 
section 704(c) of Pub. L. 91-513, set out as a note under section 801 of 
this title.

                  Section Referred to in Other Sections

    This section is referred to in sections 823, 824, 842 of this title.
