The FDA has granted another exemption from certain requirements of the Drug Supply Chain Security Act to help eligible trading partners address challenges with data exchange while ensuring patient access to medications.
This follows earlier delays in DSCSA enforcement, with many pharmacies noting they were not ready to comply with the law. The law aims to enhance the tracking of packaged therapies and grant the FDA more power to regulate compounded medications.
Here are four developments regarding the delayed enforcement:
- The exemption applies to trading partners that have made documented efforts to establish data connections with their immediate partners but still encounter difficulties.
- Separate deadlines have been set for various trading partners, with manufacturers and repackagers needing to comply by May 27, 2025, wholesale distributors by Aug. 27, 2025 and dispensers with 26 or more full-time employees by Nov. 27, 2025.
- Trading partners utilizing the exemptions are not obligated to inform the FDA about their use of them.
- The move is part of the FDA's efforts to prevent supply chain disruptions and ensure patients receive medications without delays amid ongoing concerns about pharmacy readiness.