Final Definitions and Considerations for Trading Partners to Prepare for DSCSA Implementation

From Quarles, Newsletter, 3.21. 2023

On March 16, 2023, the Food and Drug Administration (FDA) released final guidance regarding definitions of “suspect product” and “illegitimate product” as part of a continued effort to prepare trading partners for the November 27, 2023, final implementation of The Drug Supply Chain Security Act (DSCSA). This alert provides an update as to what has changed in the final definitions, as well as considerations for trading partners as they prepare for final DSCSA implementation.

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