WASHINGTON — The Healthcare Distribution Alliance announced today that pharmaceutical distributors have successfully met the Food and Drug Administration’s Drug Supply Chain Security Act (DSCSA) implementation milestone, marking the end of the agency’s phased exemption period.
The exemption, introduced in 2024, followed calls from HDA, industry partners and members of Congress for additional time to transition to the DSCSA’s complex requirements. HDA President and CEO Chester “Chip” Davis, Jr. said the achievement represents progress beyond regulatory compliance.
“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,” Davis said.
According to HDA’s June member survey, the median accuracy of data exchange between trading partners reached 98.5 percent at the package level. Davis credited the FDA’s decision to extend the timeline as instrumental in reaching that level of readiness.
While distributors are now fully operating under the DSCSA framework, pharmacies are next in line to comply. Large chain pharmacies face a November 27, 2025, deadline, followed by independent and smaller pharmacies on November 27, 2026. Davis emphasized that continued collaboration and industry support will be key in helping these stakeholders meet their obligations.
HDA has been a central voice in guiding traceability efforts since the DSCSA’s inception, working closely with the FDA and providing education to its members and supply chain partners. “As we look forward, this close coordination between public- and private-sector stakeholders will remain essential,” Davis said.
The DSCSA, enacted in 2013, is designed to enhance the security of the U.S. pharmaceutical supply chain, with full implementation requirements extending through 2026.
