CDER SBIA Update- Guidance for Industry: DSCSA Implementation: Product Tracing Requirements - Compliance Policy

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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.


The Small Business and Industry Assistance program in the Center for Drug Evaluation and Research (CDER SBIA) provides guidance and information to regulated domestic and international small pharmaceutical business and industry through its website, email notifications, and workshops. This notification system provides current information from CDER/FDA via e-mail on a biweekly basis that is relevant to small pharmaceutical business, which includes Federal Register notices, guidances, workshop announcements, etc. This is an automated message delivery system. Replying to this message will not reach the CDER SBIA staff. If you have comments or questions, please contact us Monday through Friday 8:00AM - 4:30PM.

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