PARTNERSHIP FOR DSCSA GOVERNANCE
2025 PDG-FDA Town Halls: DSCSA implementation progress
PDG and FDA will host three town halls on DSCSA implementation efforts in 2025. Each town hall will take place two months before the exemption ends for various trading partners.
These town halls will provide a forum for trading partners and other interested parties to share information on continued implementation of DSCSA interoperability and areas of remaining concern. These town halls will also provide interested parties an opportunity to share information to support all trading partners in achieving enhanced product tracing together.
The town halls will be virtual from 1 to 3 p.m. ET on the following dates:
- March 26, 2025: Progress toward end of manufacturer exemption
- June 25, 2025: Progress toward end of wholesale distributor exemption
- September 24, 2025: Progress toward end of dispenser exemption
Background: The Drug Supply Chain Security Act (DSCSA) required drug manufacturers, wholesalers, dispensers and repackagers to implement secure, electronic, interoperable systems and processes for enhanced product tracing by November 27, 2023. FDA established a 1-year stabilization period that began on November 27, 2023 and expired on November 26, 2024. On October 9, 2024, FDA issued exemptions to accommodate continued system and process improvements beyond November 27, 2024, that may be needed by trading partners to strengthen their capabilities to ensure interoperable systems and processes and to avoid supply chain disruptions. The duration of the exemption varies depending on the eligible trading partner, and expire as follows:
- Manufacturers and repackagers: May 27, 2025
- Wholesale distributors: August 27, 2025
- Dispensers with 26 or more full-time employees: November 27, 2025
Logistics: Each town hall will be virtual from 1 to 3 p.m. ET. Interested parties are invited to attend any or all town halls. Each town hall will take place two months before the exemption ends for each group of trading partners. There is no fee to attend.
Each town hall is expected to include introductory comments followed by an opportunity for interested parties to make verbal comments.
Request for Public Comment: Individuals interested in providing comments during the town hall should indicate their request to speak by checking the relevant box on the registration form at least 10 days in advance of the date at which they would like to speak. There will be no same-day registration available for speakers. We will strive to accommodate speaker requests within time constraints. Individuals and organizations with common interests are encouraged to consolidate or coordinate their comments and may submit a single request to speak. Time allotted for each speaker will depend on the number of requests received.
Contact: For questions regarding this town hall, please contact [email protected].