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Home/Regulations/DEA Controlled Substance Act (Pharmacy) — Regulatory Reference
Regulatory Reference
Pharmacy Federal (US) critical

DEA Controlled Substance Act (Pharmacy) — Regulatory Reference

Dispensing recordkeeping for Schedule I-V substances — critical sensitivity floor; AI agents gated by need-to-know with tamper-evident audit.

Key Provisions
  • 21 CFR Part 1304 — records and reports
  • 21 CFR Part 1311 — EPCS requirements
  • Closed-system distribution and tamper-evident recordkeeping
  • ARCOS reporting for distributors and manufacturers
How AutoPIL Enforces It
  • Schedule II–V dispensing data classified at CRITICAL sensitivity
  • AI agents in pharmacy support roles restricted by per-role sensitivity ceilings
  • Hash-linked audit chain mirrors closed-system tamper-evidence expectations
Audit LogPolicy EngineSensitivity LabelsAgent RegistryKey Scoping
AutoPIL Policy IDs
PHM-DEA-1304-001Dispensing Record Sensitivity
PHM-DEA-1311-001EPCS Audit Trail
Official Sources
https://www.deadiversion.usdoj.gov/21cfr/cfr/2100cfrt.htm

This page is a working reference and not a substitute for qualified legal review. Verify against official sources before use in compliance artifacts.

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