Title 21 CFR reference
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United States • Title 21 CFR • Part 1303
Part 1303 — PART 1303—QUOTAS
Part 1303 of Title 21 outlines the regulations for drug quotas, establishing a system to control the aggregate amount of controlled substances that may be manufactured or imported into the United States.
What this part covers
- Establishes aggregate production quotas for Schedule I and II controlled substances.
- Details procedures for determining and allocating quotas.
- Covers requirements for manufacturers and importers regarding quota applications and reporting.
- Addresses procedures for requesting quota increases or adjustments.
- Specifies recordkeeping and reporting obligations related to quotas.
- Outlines the process for handling temporary aggregate quotas.
- Includes provisions for the disposal of controlled substances exceeding quota limits.
- Defines the role of the Drug Enforcement Administration (DEA) in administering the quota system.
Regulatory Context
This document sits within United States CFR and is most useful when linked to operational submission, quality, and inspection workflows.
United StatesCFR