FDA Delays Drug Supply Chain Security Act Deadline Until November 2024

The FDA has issued a 1-year delay on the final enhanced drug distribution security requirements under the Drug Supply Chain Security Act (DSCSA) that were set to take effect in November. The new date, which was announced in a guidance, will be November 27, 2024.¹

The decision to delay the DSCSA requirements was made after several advocates—including the American Pharmacists Association (APhA)—warned the federal agency that the supply chain was not ready to comply. The extended time aims to allow each sector of the pharmaceutical supply chain time to develop the systems and processes necessary for efficient transactions.

In a letter to APhA members, Ilisa BG Bernstein, senior vice president of Pharmacy Practice and Government Affairs at APhA, said that the FDA was strongly urging members of the supply chain to continue preparing for the requirements, despite the delay.

“This is a huge win for pharmacists who are still working toward complying with these final supply chain security requirements,” Michael D. Hogue, executive vice president and CEO of APhA, said in a release.² “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.”

References

1. Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act--Compliance Policies. News Release. FDA. August 24, 2023. Accessed August 25, 2023. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enhanced-drug-distribution-security-requirements-under-section-582g1-federal-food-drug-and-cosmetic

2. APhA applauds FDA’s delay of the November 2023 “Track & Trace” DSCSA requirements. News Release. APhA. August 25, 2023. Accessed August 25, 2023. https://www.pharmacist.com/APhA-Press-Releases/apha-applauds-fdas-delay-of-the-november-2023-track-trace-dscsa-requirements