For eligible trading partners that meet the U.S. Food and Drug Administration (FDA) exemption’s conditions, the FDA granted exemptions from certain DSCSA requirements until the following dates:
Here is the link to the full FDA exemption announcement for small dispensers.
The FDA recognized that trading partners who had initiated their systems and processes and had established electronic DSCSA data connections with their trading partners might need additional time beyond Nov. 27, 2024, when the FDA stabilization period ended.
The DSCSA stabilization period was in place from Nov. 27, 2023 to Nov. 27, 2024. On Oct. 9, 2024, the FDA published the FDA exemption, which granted additional time, in phases, across the supply chain for eligible trading partners to exchange complete and accurate serial DSCSA transaction data.
Masters requires complete and accurate serialized DSCSA transaction data for all DSCSA product purchases from manufacturers and repackagers.
Since August 27, 2025, Masters’ distributor, McKesson, has provided complete and accurate serial DSCSA transaction data for all DSCSA in-scope product sales to their customers.
Under the FDA exemption, the new DSCSA requirements for saleable returns for all DSCSA-in-scope products are effective as of Aug. 27, 2025.
While small dispensers (25 or fewer pharmacists/technicians) have an exemption from certain DSCSA serialization requirements until Nov. 27, 2026, the DSCSA requirements for distributors for saleable returns have been in effect since August 27, 2025.
Masters will continue to update resources located in your ordering portals (DSCSA Information for Your Pharmacy – MastersRx.com). We remain committed to assisting you where possible during any FDA exemption period.
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