GDP in the US: Updates on Implementation of DSCSA

As part of the phased implementation of the Drug Supply Chain Security Act (DSCSA), the U.S. Food and Drug Administration (FDA) and the Partnership for DSCSA Governance (PDG) hosted a virtual town hall on 26 March 2025. The meeting focused on the approaching end of the manufacturer exemption and provided an opportunity for stakeholders to exchange views on the progress and remaining challenges related to DSCSA interoperability.

Further Sessions

Two further sessions are planned, taking place two months before the exemption period ends for each group of trading partners:

• 25 June 2025 – Progress toward end of wholesale distributor exemption

• 24 September 2025 – Progress toward end of dispenser exemption

These virtual town halls will provide a forum for trading partners and other interested parties to share information on continued implementation of DSCSA.

Background

In connection with the continued implementation of DSCSA, the FDA has granted temporary exemptions for trading partners who have made substantial efforts to establish electronic data connections but still face technical challenges. The exemption periods are as follows:

• Manufacturers and repackagers: until 27 May 2025
• Wholesale distributors: until 27 August 2025
• Dispensers with 26 or more full-time employees: until 27 November 2025
• Small dispensers (25 or fewer full-time pharmacy staff): until 27 November 2026

Trading partners not qualifying for these exemptions may submit individual waiver or exemption requests in accordance with FDA guidance. The FDA has emphasized that submission of such a request does not pause or extend the obligation to comply by the applicable deadline.

Further information is available on the FDA’s DSCSA page.