Get your supply chain ready for DSCSA's enhanced requirements.
The stabilization period is over. Manufacturers, wholesalers, and dispensers are now on the hook for interoperable, package-level tracing, verification, and authorized-trading-partner rules. This checklist turns Section 582(g) into a list you can work through.
The one-year stabilization period ended 27 Nov 2024. FDA's tiered exemptions have since expired for wholesale distributors (27 Aug 2025) and larger dispensers (27 Nov 2025); the small-dispenser exemption (25 or fewer full-time pharmacists and technicians) was extended by FDA in Aug 2026 and now ends 27 Nov 2027. Treat the enhanced requirements as live.
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When are the DSCSA enhanced requirements enforced?
The one-year stabilization period ended 27 November 2024. FDA's tiered exemptions have since expired for wholesale distributors (27 August 2025) and larger dispensers (27 November 2025); the small-dispenser exemption (25 or fewer full-time pharmacists and pharmacy technicians) was extended by FDA in August 2026 and now ends 27 November 2027. Treat the enhanced Section 582(g) requirements as in effect now.
What do the enhanced DSCSA requirements actually require?
Secure, interoperable, electronic tracing of prescription drugs at the package level; enhanced verification including saleable returns; transacting only with authorized trading partners; and suspect and illegitimate-product handling. EPCIS is the common interoperable data format.
Who has to comply with DSCSA?
Pharmaceutical manufacturers, repackagers, wholesale distributors, dispensers (pharmacies), and third-party logistics providers handling prescription human drugs in the US supply chain.
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