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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