The FDA has extended the deadline for drug and device manufacturers, distributors, and others to comply with enhanced drug distribution security requirements under the Drug Supply Chain Security Act (DSCSA). Originally set for November 27, 2023, the new enforcement deadline is November 27, 2024.

These requirements involve implementing secure electronic methods for exchanging transaction information, verifying products at the package level, responding to recalls or investigations, and more. This extension is meant to give businesses more time to adapt to these new rules, but it's important to note that it's not a justification for delaying compliance efforts. Failure to prepare may lead to enforcement action by the FDA. Trading Partners who can't meet these requirements can explore FDA guidance on waivers, exceptions, and exemptions.


Full article from JDSUPRA here.

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