(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 therefore 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.)
