21 CFR 1303.11 - Aggregate production quotas.
(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 Federal Register, general notice of an aggregate production quota for any basic class determined by him under this section. A copy of said notice shall be mailed simultaneously to each person registered as a bulk manufacturer of the basic class. The Administrator shall permit any interested person to file written comments on or objections to the proposal and shall designate in the notice the time during which such filings may be made. The Administrator may, but shall not be required to, hold a public hearing on one or more issues raised by the comments and objections filed with him. In the event the Administrator decides to hold such a hearing, he shall publish notice of the hearing in the Federal Register, which notice shall summarize the issues to be heard and shall set the time for the hearing which shall not be less than 30 days after the date of publication of the notice. After consideration of any comments or objections, or after a hearing if one is ordered by the Administrator shall issue and publish in the Federal Register his final order determining the aggregate production quota for the basic class of controlled substances. The order shall include the findings of fact and conclusions of law upon which the order is based. The order shall specify the date on which it shall take effect. A copy of said order shall be mailed simultaneously to each person registered as a bulk manufacturer of the basic class.