FDA is issuing exemptions from certain requirements of section 582 of the Food, Drug and Cosmetic Act to small dispensers (pharmacies), and where applicable, their trading partners, until November 27, 2026. This provides small dispensers additional time to stabilize their operations to fully implement the enhanced drug distribution security requirements of DSCSA.
Additionally, FDA is reminding trading partners the Drug Supply Chain Security Act (DSCSA) one-year stabilization period ends on November 27, 2024. The agency is not extending the stabilization period beyond this date.
Trading partners that do not qualify for the small dispenser exemptions and are unable to meet the enhanced drug distribution security requirements by November 27, 2024, may request a waiver or exemption from those requirements. The agency expects the trading partner to continue their efforts to meet the requirements until FDA has approved or denied the request. FDA also reopened a request for information to better understand the status of trading partners’ interoperable systems and processes for enhanced drug distribution security.
Join us June 17 and 18 for our joint public meeting with Partnership for DSCSA Governance on implementation and stabilization efforts.
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