10 Oct FDA Grants Exemption to Connected Trading Partners

Posted at 15:20h in FDA by

The FDA has announced exemptions for certain trading partners from the enhanced drug distribution security requirements under section 582 of the Food, Drug, and Cosmetic Act (FD&C Act). These exemptions aim to avoid disruptions in the pharmaceutical supply chain, ensuring patients have continuous access to essential medications while progressing toward full Drug Supply Chain Security Act (DSCSA) compliance.

Eligible trading partners who have completed, or are in the process of establishing, data connections with their immediate partners but face difficulties in data exchange can benefit from these exemptions. The timeline for exemptions varies depending on the type of trading partner:

  • Manufacturers and Repackagers: Until May 27, 2025
  • Wholesale Distributors: Until August 27, 2025
  • Dispensers with 26 or more employees: Until November 27, 2025

The FDA is also offering an extended exemption for small dispensers, Pharmacies with 25 or fewer full-time employees, until November 27, 2026.

This extension gives smaller businesses more time to adapt and fully implement the enhanced drug distribution security requirements.

Requesting Waivers Beyond the Exemption Period

Trading partners unable to meet the November 27, 2024, compliance deadline can request waivers or exemptions. However, they must continue efforts to comply with the requirements while awaiting an FDA response. Requests should include detailed justifications and supporting documentation as outlined in FDA guidance.

These exemptions reflect the FDA’s commitment to balancing regulatory progress with patient access and supply chain stability.

For more information on how to submit your request, click on the link Waivers and Exemptions Beyond the Stabilization Period | FDA

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