21 C.F.R. § 1303.11 Aggregate production quotas.
Title 21 - Food and Drugs
(a) The Administrator shall determine the total quantity of each basic class of controlled substance listed in Schedule I or II necessary to be manufactured during the following 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. (b) In making his determinations, the Administrator shall consider the following factors: (1) Total net disposal of the class by all manufacturers during the current and 2 preceding years; (2) Trends in the national rate of net disposal of the class; (3) Total actual (or estimated) inventories of the class and of all substances manufactured from the class, and trends in inventory accumulation; (4) Projected demand for such class as indicated by procurement quotas requested pursuant to §1303.12; and (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 shall, on or before May 1 of each year, publish in the [36 FR 7786, Apr. 24, 1971, as amended at 37 FR 15919, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973]
Title 21: Food and Drugs
PART 1303—QUOTAS
Aggregate Production and Procurement Quotas
§ 1303.11 Aggregate production quotas.