Product Identifier Requirements Under the Drug Supply Chain Security Act-Compliance Policy; Guidance for Industry; Availability

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The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Product Identifier Requirements Under the Drug Supply Chain Security Act-- Compliance Policy." This guidance describes FDA's intention with regard to enforcement of the Drug Supply Chain Security Act (DSCSA) provision requiring manufacturers to begin affixing or imprinting product identifiers on their products beginning November 27, 2017. This guidance finalizes the draft guidance issued on July 3, 2017.