What US DEA 21 CFR Parts 1301-1308 - Controlled Substances Registration and Manufacturing Requirements requires
The US Drug Enforcement Administration (DEA) regulations at 21 CFR Parts 1301-1308 implement the Controlled Substances Act (CSA), requiring registration for all manufacturers, distributors, dispensers, and researchers handling Schedule I-V controlled substances. DEA Schedule determines registration type, manufacturing quotas, record-keeping obligations (2-year retention), and reporting requirements including ARCOS (Automation of Reports and Consolidated Orders System) for bulk manufacture and distribution.
Pillar: Pharmaceuticals & Life Sciences · Authority: US Drug Enforcement Administration (DEA) · Version: 1.0.0 · Last updated:
Primary source: https://www.ecfr.gov/current/title-21/chapter-II/part-1301
SHA-256 integrity: 8e06cfa0f84c5dc806cef46ded28ed687795bec1801f47b299a154e4d72d1297
Primary Citations — 5 traced to source
- {"title":"21 CFR Part 1301 - Registration of Manufacturers, Distributors, and Dispensers","url":"https://www.ecfr.gov/current/title-21/chapter-II/part-1301","section":"Security requirements and registration procedures"}
- {"title":"21 CFR Part 1304 - Records and Reports of Registrants","url":"https://www.ecfr.gov/current/title-21/chapter-II/part-1304","section":"1304.21 (general records), 1304.22 (inventory)"}
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