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Regulatory Reference
Pharmacy Federal (US) critical

FDA REMS Programs — Regulatory Reference

Restricted distribution for high-risk drugs — critical sensitivity floor; AutoPIL enforces agent-level access restrictions on dispensing data.

Key Provisions
  • Elements to Assure Safe Use (ETASU) — certifications, registries, lab monitoring
  • Shared System REMS — coordination across multiple sponsors
  • Implementation Systems for restricted distribution
How AutoPIL Enforces It
  • REMS-controlled medication data classified at CRITICAL sensitivity
  • Agent registry binds AI agent identity to ETASU certifications where applicable
  • Audit chain provides ETASU compliance evidence
Policy EngineAudit LogSensitivity LabelsAgent Registry
AutoPIL Policy IDs
PHM-FDA-REMS-001REMS Medication Boundary
PHM-FDA-ETASU-001ETASU Compliance Evidence
Official Sources
https://www.fda.gov/drugs/drug-safety-and-availability/risk-evaluation-and-mitigation-strategies-rems

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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