Registration of Manufacturers, Distributors and Dispensers of Controlled Substances
DEA registration requirements for every person manufacturing, distributing, dispensing, importing or exporting controlled substances, including the physical-security and employee-screening obligations that attach to registration.
Any site handling scheduled substances — including R&D quantities and reference standards. Registration is per site and per business activity, not per company.
- 01Current DEA registration for each site and each business activity
- 02Physical security controls appropriate to the schedules handled
- 03Employee screening programme and diversion-reporting procedures
- 04Notification to DEA on relevant changes
21 CFR Part 1301: frequently asked questions
Quick answers to common questions about 21 CFR Part 1301.
What is 21 CFR Part 1301?
21 CFR Part 1301 — Registration of Manufacturers, Distributors and Dispensers of Controlled Substances — is a regulation issued by the Drug Enforcement Administration (United States). DEA registration requirements for every person manufacturing, distributing, dispensing, importing or exporting controlled substances, including the physical-security and employee-screening obligations that attach to registration.
Who does 21 CFR Part 1301 apply to?
Any site handling scheduled substances — including R&D quantities and reference standards. Registration is per site and per business activity, not per company.
What are the key requirements of 21 CFR Part 1301?
DEA 21 CFR Part 1301 requires, among other things: Current DEA registration for each site and each business activity; Physical security controls appropriate to the schedules handled; Employee screening programme and diversion-reporting procedures; Notification to DEA on relevant changes.
When was 21 CFR Part 1301 last updated?
The current version of 21 CFR Part 1301 dates from January 2023.
Live openFDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.
Track the standards that move
When 21 CFR Part 1301 — or any GxP requirement — is revised, recalled against, or clarified by new guidance, the Weekly GxP Briefing surfaces it. Free, one email a week.