Records and Reports of Registrants
The recordkeeping and reporting obligations of DEA registrants: inventories, receipt and distribution records, retention periods, and the reporting of losses and thefts.
All DEA registrants. Records must be maintained per registered location and be readily retrievable, which shapes how a controlled-substance inventory system must be designed.
- 01Complete receipt-to-disposition records for controlled substances
- 02Inventories taken and documented at the required intervals
- 03Loss and theft reporting to DEA
- 04Records retained for the required period and readily retrievable
21 CFR Part 1304: frequently asked questions
Quick answers to common questions about 21 CFR Part 1304.
What is 21 CFR Part 1304?
21 CFR Part 1304 — Records and Reports of Registrants — is a regulation issued by the Drug Enforcement Administration (United States). The recordkeeping and reporting obligations of DEA registrants: inventories, receipt and distribution records, retention periods, and the reporting of losses and thefts.
Who does 21 CFR Part 1304 apply to?
All DEA registrants. Records must be maintained per registered location and be readily retrievable, which shapes how a controlled-substance inventory system must be designed.
What are the key requirements of 21 CFR Part 1304?
DEA 21 CFR Part 1304 requires, among other things: Complete receipt-to-disposition records for controlled substances; Inventories taken and documented at the required intervals; Loss and theft reporting to DEA; Records retained for the required period and readily retrievable.
When was 21 CFR Part 1304 last updated?
The current version of 21 CFR Part 1304 dates from January 2023.
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When 21 CFR Part 1304 — or any GxP requirement — is revised, recalled against, or clarified by new guidance, the Weekly GxP Briefing surfaces it. Free, one email a week.