21 CFR § 1303.21 - Individual manufacturing quotas.

---
identifier: "/us/cfr/t21/s1303.21"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 1303.21 - Individual manufacturing quotas."
title_number: 21
title_name: "Food and Drugs"
section_number: "1303.21"
section_name: "Individual manufacturing quotas."
chapter_name: "DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE"
part_number: "1303"
part_name: "QUOTAS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 821, 826, 871(b)."
cfr_part: "1303"
---


# 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;  88 FR 60141, Aug. 31, 2023]