Title 21 CFR reference
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United States • Title 21 CFR • Part 1304
Part 1304 — PART 1304—RECORDS AND REPORTS OF REGISTRANTS
Part 1304 outlines the recordkeeping and reporting requirements for registrants under the Drug Enforcement Administration (DEA). It details the types of records to be maintained, the duration for which they must be kept, and the specific reports that must be submitted to the DEA. This includes records of controlled substances manufactured, distributed, imported, exported, and dispensed, as well as reports on suspicious orders and inventory.
What this part covers
- Establishes requirements for maintaining records of all controlled substances manufactured, received, distributed, imported, exported, or otherwise disposed of.
- Specifies the duration for which records must be kept, generally two years from the date of such record.
- Details the reporting requirements for suspicious orders of controlled substances.
- Outlines the procedures for conducting and reporting inventories of controlled substances.
- Covers recordkeeping for research, analytical, and chemical analysis purposes.
- Addresses specific recordkeeping for Schedule I and II controlled substances.
- Requires registrants to maintain records and files in a manner that is readily retrievable and accessible for inspection by the DEA.
Regulatory Context
This document sits within United States CFR and is most useful when linked to operational submission, quality, and inspection workflows.