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Home/Regulations/DSCSA — Drug Supply Chain Security Act — Regulatory Reference
Regulatory Reference
Pharmacy Federal (US) high

DSCSA — Drug Supply Chain Security Act — Regulatory Reference

Track-and-trace for prescription drugs — lineage tracking for supply chain data access by AI agents.

Key Provisions
  • Interoperable, electronic, package-level tracing requirements
  • Verification, investigation, and notification of suspect and illegitimate products
  • Stabilization period (FDA exercised enforcement discretion through late 2024/2025)
  • Authorized trading partner requirements
How AutoPIL Enforces It
  • Source registry treats supply chain trace data as a governed source with classification
  • Audit chain documents AI agent access to trace data — supports illegitimate product investigations
  • Agent registry distinguishes manufacturer, wholesaler, and dispenser AI roles
Audit LogPolicy EngineSensitivity LabelsLineage
AutoPIL Policy IDs
PHM-DSCSA-TR-001Trace Data Access Logging
PHM-DSCSA-ATP-001Authorized Trading Partner AI Boundary
Official Sources
https://www.fda.gov/drugs/drug-supply-chain-integrity/drug-supply-chain-security-act-dscsa

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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