Section 1303.21 - Individual manufacturing quotas(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).36 FR 7786, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, as amended at 62 FR 13958, Mar. 24, 1997; 83 FR32790, July 16, 2018 83 FR 32790 , 8/15/2018; 88 FR 60141 , 11/29/2023