On October 9, 2024, the FDA announced a partial exemption from certain DSCSA requirements for trading partners who have initiated their systems and processes, including establishing electronic data connections with their immediate trading partners. The FDA’s decision was made to allow additional time for resolving issues related to data exchange, quality, and reliability, which many in the industry are still navigating.

Notice from FDA

Key details of the exemption:

• Who is affected: Trading partners who have initiated their systems and electronic data connections, but who still face challenges with missing, incomplete, or inaccurate data.
• What is exempted: Key interoperable DSCSA requirements like exchanging transaction information and transaction statements electronically, including product identifiers at the package level, and certain verification request requirements.
• Timeline:
  • For manufacturers and repackagers, exemptions last from November 27, 2024, until May 27, 2025.
  • For wholesalers, exemptions are granted until August 27, 2025.
  • For dispensers with 26 or more full-time employees, the exemption period extends until November 27, 2025.
• Scope: These exemptions apply to specific requirements under Section 582(g)(1) of the FD&C Act. Other existing DSCSA obligations, remain in effect. Notably, trading partners who have not yet initiated the required systems are not covered by these exemptions.

Trading partners who utilize these exemptions do not need to notify FDA. However, it is essential to note that this exemption is not a pause on all DSCSA requirements. For example, the FDA will still be enforcing sections not covered by this exemption, such as ensuring processes/systems in place to identify, quarantine, and communicate illegetimate product continue to be in place. Compliance enforcement actions are already happening, as highlighted in our recent blog on DSCSA requirements (which you can read here).

The FDA strongly urges all trading partners to continue working towards full DSCSA compliance and not to delay. This exemption is meant to support the industry during this transition, but it's crucial that efforts remain focused on achieving full compliance by the respective deadlines.

If you have any questions or need assistance navigating these requirements, please don’t hesitate to reach out.

Ten Count Consulting Team

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