PDG-FDA Joint Public Meeting
June 17, 2024 12:30pm – 5:30pm | June 18 10:00am – 4:00pm | Washington, DC
Background: The Drug Supply Chain Security Act (DSCSA) required drug manufacturers, wholesalers, dispensers, and repackagers to implement secure, electronic, interoperable systems and process for enhanced product tracing by November 27, 2023. In August 2023, FDA published its Compliance Policy, Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act, which established a 1-year stabilization period. This stabilization period is intended to afford trading partners the necessary flexibility to maintain patient access to medicines while the industry undertakes necessary actions to mature and stabilize their interoperable systems and processes.