Revised Dispenser Compliance Policy - Extended to March 1, 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 has 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.  

 

FDA previously published a Compliance Policy on July 6, 2015. It stated 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. 

 

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