Compliance Briefing — August 18, 2025
FDA’s Drug Supply Chain Security Act interoperability enforcement has been live since November 2024, and wholesalers now have six weeks to remediate any electronic tracing gaps before FY2025 inspection cycles ramp up.
Executive briefing: FDA’s November 27 2024 compliance policy ended the stabilization period for DSCSA interoperable electronic tracing. Manufacturers, repackagers, wholesale distributors, and dispensers must now exchange transaction information, histories, and statements electronically and provide serialized package-level data within 24 hours of regulatory requests.
Key compliance checkpoints
- Interoperability testing. Confirm EPCIS 1.2/1.3 message exchange works with all trading partners, including mixed-lot and saleable returns scenarios.
- Exception management. Maintain procedures for quarantine, investigation, and disposition of suspect or illegitimate product, documenting outcomes in accordance with §582.
- Data retention. Ensure transaction records remain accessible for six years, with disaster recovery plans validated for serialized repositories.
Operational priorities
- Partner readiness. Run joint drills with third-party logistics providers and dispensers to ensure electronic requests can be fulfilled inside 24 hours.
- Inspection playbooks. Update FDA inspection binders with system diagrams, role-based access controls, and evidence of verification inquiries handled since November 2024.
- Analytics integration. Feed serialization and verification events into diversion and chargeback analytics to surface anomalies rapidly.
Enablement moves
- Instrument dashboards highlighting unresolved EPCIS errors, partner acknowledgements, and verification turnaround times.
- Schedule quarterly tabletop exercises simulating large-scale product recalls that stress-test DSCSA data exchange.
Sources
Zeph Tech secures DSCSA interoperability with EPCIS conformance testing, evidence vaults, and inspection response automation.