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Published on Friday, August 25, 2023

APhA applauds FDA’s delay of the November 2023 “Track & Trace” DSCSA requirements

Washington, DC (August 25, 2023) — APhA appreciates FDA’s one-year delay for supply chain trading partners to comply with the final enhanced drug distribution security requirements under the Drug Supply Chain Security Act (DCSCA) that were scheduled to take effect on November 27, 2023.

This delay will help achieve DSCSA’s prescription drug product traceability and security goals while minimizing supply disruptions and avoiding interruptions to patient care.

FDA announced this delay in guidance that provides information to assist supply chain partners, including dispensers such as pharmacies, in complying with FDA’s requirements for enhanced drug distribution security for tracing at the package level. This one-year delay will allow all sectors of the pharmaceutical supply chain time to stabilize the complex systems and processes necessary for efficient transactions across the supply chain.

“This is a huge win for pharmacists who are still working toward complying with these final supply chain security requirements,” said Michael D. Hogue, PharmD, FAPhA, FNAP, FFIP, executive vice president and CEO of APhA. “APhA has strongly advocated to FDA with our concerns for the readiness of all supply chain members and we appreciate FDA taking this important step to delay compliance with these requirements to ensure patients will be able to get the medications they need without unnecessary disruptions in the supply chain.”

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