Lexology September 25, 2023
With a November 2023 compliance deadline fast approaching, FDA publishes guidance explaining a one-year delayed enforcement of certain obligations, including interoperable, electronic, and package-level product tracing requirements.
On August 28, 2023, the U.S. Food and Drug Administration (“FDA”) issued compliance policies regarding the §582(g)(1) enhanced drug distribution security requirements of the Federal Food, Drug, and Cosmetic Act. While trading partners—manufacturers, repackagers, wholesale distributors, and dispensers—and FDA have been preparing for enhanced drug distribution security since the 2013 enactment of the Drug Supply Chain Security Act (“DSCSA”), industry concerns regarding readiness and a stated need for clarity and flexibility to ensure continued product movement through the supply chain prompted agency action. FDA’s enforcement discretion is intended to provide additional time to...
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