In August 2023, the U.S. Food and Drug Administration (“FDA”) issued two compliance policies that outlined its strategy for enforcing the drug distribution security requirements established by the Drug Supply Chain Security Act (“DSCSA”), which were set to take effect on November 27, 2023. To support trading partners in meeting these requirements, FDA implemented a one-year “stabilization period,” scheduled to end on November 27, 2024. On October 9, 2024, FDA announced an exemption from the enhanced drug distribution requirements under the DSCSA for eligible trading partners, giving these trading partners additional time beyond the upcoming November 27, 2024, deadline to mature their processes for interoperability. The new exemption only applies to trading partners who have initiated their systems and processes and have established electronic DSCSA data connections with their trading partners, but still face challenges exchanging data.
FDA’s primary objective in taking this action is to “avoid supply chain disruptions and ensure patients will not face delays in receiving the medicines they need.” The decision was also influenced by concerns raised by key stakeholders in the pharmaceutical distribution supply chain regarding their readiness to fully comply with the DSCSA requirements by November 2024. Among the challenges recognized by FDA were issues with missing or inaccurate data in electronic DSCSA transaction records, which could lead to delays in the distribution of critical products, including those currently in shortage.
FDA is implementing this exemption in a phased manner, with specific compliance deadlines based on the type of entity:
- Manufacturers and Repackagers: May 27, 2025
- Wholesale Distributors: August 27, 2025
- Dispensers with 26 or more full-time employees: November 27, 2025
- Small Dispensers*: November 27, 2026
*Small Dispensers are companies with 25 or fewer full-time employees licensed as pharmacists or qualified as pharmacy technicians.
FDA also released a detailed document outlining the DSCSA requirements covered by this exemption. Importantly, eligible trading partners do not need to notify FDA if they take advantage of this extension. However, for those not eligible, FDA reminded them that they can still apply for a waiver, exception or exemption from the enhanced security requirements, with the agency aiming to address these requests before the November 27, 2024, deadline.
If you have questions about these updates, please contact:
- Carolina Wirth at (202) 780-2989 or cwirth@hallrender.com;
- Todd Nova at (414) 721-0464 or tnova@hallrender.com;
- Benjamin Lockwood at (414) 721-0484 or blockwood@hallrender.com; or
- Your primary Hall Render contact.
Hall Render blog posts and articles are intended for informational purposes only. For ethical reasons, Hall Render attorneys cannot—outside of an attorney-client relationship—answer specific questions that would be legal advice.
