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Home/Regulations/DEA Controlled Substance Rules (Healthcare) — Regulatory Reference
Regulatory Reference
Healthcare Federal (US) critical

DEA Controlled Substance Rules (Healthcare) — Regulatory Reference

Prescribing and dispensing recordkeeping for Schedule I-V substances — critical sensitivity floor with strict need-to-know enforcement.

Key Provisions
  • 21 CFR Part 1304 — records and reports of registrants
  • 21 CFR Part 1311 — electronic orders and electronic prescriptions for controlled substances (EPCS)
  • Two-year recordkeeping for Schedule II inventory records; longer for some categories
  • Strict separation of Schedule II records from other prescription data
How AutoPIL Enforces It
  • Controlled substance prescription data classified at CRITICAL sensitivity
  • Per-role access — clinical agents may see, billing agents may not
  • Tamper-evident audit chain meets EPCS audit expectations under 21 CFR 1311
Audit LogPolicy EngineSensitivity LabelsAgent RegistryKey Scoping
AutoPIL Policy IDs
HC-DEA-1304-001Controlled Substance Record Sensitivity Floor
HC-DEA-1311-001EPCS Audit Trail Requirements
Official Sources
https://www.deadiversion.usdoj.gov/21cfr/cfr/2100cfrt.htmhttps://www.dea.gov/drug-information/drug-scheduling

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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