Individual manufacturing quotas.

21 C.F.R. § 1303.21
in effectEffective: 2024-07-01
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(a) The Administrator shall, on or before December 1 of each year, fix for and issue to each person who is registered to manufacture a basic class of controlled substance listed in Schedule I or II, and who applies for a manufacturing quota, an individual manufacturing quota authorizing that person to manufacture during the next calendar year a quantity of that basic class. The Administrator may establish an individual manufacturing quota in terms of pharmaceutical dosage-forms prepared from or containing the schedule I or II controlled substance, if they determine it will assist in avoiding the overproduction, shortages, or diversion of a controlled substance. Any manufacturing quota fixed and issued by the Administrator shall be subject to his authority to reduce or limit it at a later date pursuant to § 1303.26 and to his authority to revoke or suspend it at any time pursuant to § 1301.36 of this chapter. (b) No individual manufacturing quota shall be required for registrants listed in § 1303.12(e).

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