Guidance for Industry:
DSCSA Implementation: Product Tracing Requirements - Compliance Policy
Today, FDA posted guidance to inform industry that we do not intend to take action against manufacturers, wholesale distributors, or repackagers who do not, prior to May 1, 2015, provide or capture the product tracing information required by sections 582(b)(1), (c)(1), and (e)(1) of the FD&C Act. This action is to minimize possible disruptions in the distribution of prescription drugs in the United States.
For more information, please visit the FDA “Are you ready for the Drug Supply Chain Security Act” web page, which contains an industry-focused checklist, links and descriptions for each of the DSCSA requirements which go in to effect on Jan. 1, 2015.
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