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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.

New draft and finalized guidance docs were recently released regarding product identifiers and grandfathering.
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This 14-page draft guidance is intended to address anticipated questions regarding product identifiers that are required under section 582 of the Federal Food, Drug, and Cosmetic Act as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.

Manufacturers and repackagers must affix or imprint a product identifier to each package and homogenous case on Nov. 27, 2017 and Nov. 28, 2018, respectively.

2. Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier

This 9-page guidance addresses product distribution security provisions in section 582 of the Federal Food, Drug, and Cosmetic Act.

3. Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy

This 4-page guidance addresses the requirement in section 582(b)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) that manufacturers affix or imprint a product identifier to each package and homogenous case of a product intended to be introduced in a transaction into commerce beginning not later than November 27, 2017. It also points to the finalized grandfathering guidance.

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