Regulations
& Codified CSA > USC > Subchapter
I, Part C > Section 826
Section 826. Production Quotas for Controlled Substances
Establishment of total annual needs
(a) 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.
Individual production quotas; revised quotas
(b) 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.
Manufacturing quotas for registered manufacturers
(c) 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.
Quotas for registrants who have not manufactured controlled substance during one or more
preceding years
(d) 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.
Quota increases
(e) 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.
Incidental production exception
(f) 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, Section 306, Oct. 27, 1970, 84 Stat. 1257; Pub.L. 94-273, Section 3(16),
Apr. 21, 1976, 90 Stat. 377.)
EDITORIAL NOTES
References in Text. Schedules I and II, referred to in text, are set out in section 812(c) of this
title.
Code of Federal Regulations
Quotas, see 21 CFR 1303.01 et seq.
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