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News & Press: Federal Legislation

FDA Delays Enforcement of Track and Trace

Thursday, October 29, 2015   (0 Comments)
Posted by: Jenny Arnold
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The FDA announced yesterday that it will delay enforcement of the DSCSA, commonly known as the “Track and Trace” requirements until March 1st, 2016. The Drug Supply Chain Security Act (DSCSA) required dispensers, which primarily include pharmacies, to comply with new requirements related to product tracing beginning July 1, 2015. FDA previously published a Compliance Policy on July 6, 2015 stating the FDA did not intend to take action until November 1, 2015, against dispensers that accepted ownership of product without receiving the product tracing information or who did not capture and maintain the product tracing information as required by the law. This has been extended again. 


On October 28th, the FDA issued a guidance, DSCSA Implementation: Product Tracing Requirements for Dispensers–Compliance Policy (Revised), announcing that it is extending a previously issued Compliance Policy from November 1, 2015 to March 1, 2016 because some dispensers – primarily smaller, independent pharmacies and health systems – have expressed that they need additional time.


Please check: http://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/DrugSupplyChainSecurityAct/default.htm for the latest activities on the DSCSA.


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