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

With an aim to offer more guidance on the Drug Supply Chain and Security Act (DSCSA), the US Food and Drug Administration (FDA) on Wednesday finalized two guidances and drafted a question and answer document on product identifiers.

The guidance follows FDA’s decision to delay by one year – until 26 November – its enforcement of the requirement for manufacturers to affix or imprint product identifiers.

 

Product Identifiers Under the Drug Supply Chain Security Act: Questions and Answers

Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier Guidance for Industry

Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy Guidance for Industry

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