Regulations last checked for updates: May 19, 2024

Title 21 - Food and Drugs last revised: May 15, 2024
§ 1303.03 - Types of quotas.

The three types of quotas are:

(a) Aggregate production quotas, which establish the total quantity of each basic class of schedules I and II controlled substances that may be produced by all manufacturers in a calendar year.

(b) Individual manufacturing quotas, which establish the maximum quantity of each basic class of schedules I and II controlled substances that a registered manufacturer may manufacture during a calendar year. This type of quota is only issued to DEA-registered bulk manufacturers.

(c) Procurement quotas, which establish the maximum quantity of each basic class of schedules I and II controlled substances that a registered manufacturer may procure during a calendar year for the purpose of manufacturing into dosage-forms or other substances.

[88 FR 60139, Aug. 31, 2023]
authority: 21 U.S.C. 821,826,871
cite as: 21 CFR 1303.03