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 Nov 27, 2024. FDA's tiered exemptions have since expired for wholesale distributors (Aug 27, 2025) and larger dispensers (Nov 27, 2025); the small-dispenser exemption (≤25 staff) ends Nov 27, 2026. Treat the enhanced requirements as live.
Your checklist is downloading now, and we’ve sent a copy to your email.
Download againThe one-year stabilization period ended November 27, 2024. FDA's tiered exemptions have since expired for wholesale distributors (August 27, 2025) and larger dispensers (November 27, 2025); the small-dispenser exemption (25 or fewer staff) ends November 27, 2026. Treat the enhanced Section 582(g) requirements as in effect now.
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.
Pharmaceutical manufacturers, repackagers, wholesale distributors, dispensers (pharmacies), and third-party logistics providers handling prescription human drugs in the US supply chain.
A fixed-fee, 14-day Aeroz audit maps your own products against this checklist — a written gap analysis, with no commitment to proceed.