{"data":{"id":"us/21-cfr-1303.21","jurisdiction":"us","citation":"21 CFR 1303.21","heading":"Individual manufacturing quotas.","body":"(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.\n(b) No individual manufacturing quota shall be required for registrants listed in § 1303.12(e).","path":["Title 21—Food and Drugs","CHAPTER II—DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE","PART 1303—QUOTAS"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"bace34c17020fc5e7dfcdf4266a2bc8e1f60e023bf73bff2bcec82c849f56ef1","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-1303.17","next":"us/21-cfr-1303.22"},"notice":"GroundRules: Original legal text. Not legal advice."}