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U.S. FDA Guidance on DSCSA

On June 3, 2021, the FDA released four guidance documents with new/updated recommendations regarding compliance with the U.S. Drug Supply Chain Security Act (DSCSA).

Our regulatory team has been analyzing and summarizing these documents in order to develop detailed summaries.


Suspect & Illegitimate Product Guidance for Industry
This document summarizes two FDA guidance documents within one summary document to provide guidance on suspect & illegitimate product.

This document summarizes the following two guidance documents:
-Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act: Guidance for Industry
-Implementation: Identification of Suspect Product and Notification: Guidance for Industry


Final Guidance for Product Identifiers Q&A
This document summarizes the following guidance document:
-Product Identifiers Under the Drug Supply Chain Security Act Questions and Answers: Guidance for Industry


Enhanced Drug Distribution Guidance
This document summarizes the following guidance document:
-Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act: Guidance for Industry