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ICYMI: FDA Released Three DSCSA-Related Guidances

New draft and finalized guidance docs were recently released regarding product identifiers and grandfathering.

The following is a list of recent guidance documents released or finalized by the FDA. For more analysis of these documents, check out Dirk Rogers’ column: FDA’s Late Recommendation on Human-Readable Format

1. Product Identifiers Under the Drug Supply Chain Security Act- Questions and Answers Guidance for Industry

This 14-page draft guidance is intended to address anticipated questions regarding product identifiers that are required under section 582 of the Federal Food, Drug, and Cosmetic Act as amended by the Drug Supply Chain Security Act (DSCSA) for packages and homogenous cases of certain drug products.

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