21 U.S.C. § 826 : US Code - Section 826: Production quotas for controlled substances

Search 21 U.S.C. § 826 : US Code - Section 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.