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HDA Statement on DSCSA Implementation Milestone For Distributors

August 27, 2025

The Healthcare Distribution Alliance (HDA) released a statement from President and CEO Chester “Chip” Davis, Jr., at the close of the Food and Drug Administration’s (FDA) Drug Supply Chain Security Act (DSCSA) exemption period for distributors. This phased-in exemption period was introduced in 2024 following extensive feedback from HDA, industry stakeholders and members of Congress who called on the FDA to provide the pharmaceutical supply chain with more time to adapt to the law’s complex processes.

“With today’s DSCSA distributor deadline, we have reached a milestone that goes beyond just compliance — it is about strengthening the safety and security of the entire healthcare supply chain for patients. HDA is pleased that, at the conclusion of the FDA’s exemption period, the distribution sector has been successful in meeting its implementation responsibilities. According to the most recent survey of HDA members, as of early June, the median level of accurate data exchange between trading partners at the pieces level was 98.5 percent. This high completion rate was only made possible through FDA’s willingness to extend the implementation period, and we thank the agency for their leadership.

“While the systems are functioning well, the work of the healthcare supply chain is not done. Larger chain pharmacies and smaller pharmacies still need to reach their own exemption deadlines on November 27, 2025, and November 27, 2026, respectively. These stakeholders will need our sector’s ongoing support and assistance over the next 15 months.

“As the leading voice on traceability from the very beginning, HDA has worked closely with the FDA and served as a critical source of reliable education and guidance for our members, as well as upstream and downstream supply chain partners. As we look forward, this close coordination between public- and private-sector stakeholders will remain essential.”

For more information on pharmaceutical traceability, click here.

About the Healthcare Distribution Alliance
The Healthcare Distribution Alliance (HDA) represents primary pharmaceutical distributors — the vital link between the nation’s pharmaceutical manufacturers and pharmacies, hospitals, long-term care facilities, clinics and others nationwide. Since 1876, HDA has helped members navigate regulations and innovations to get the right medicines to the right patients at the right time, safely and efficiently. The HDA Research Foundation, HDA’s nonprofit charitable foundation, serves the healthcare industry by providing research and education focused on priority healthcare supply chain issues.