viernes, 30 de octubre de 2015

Drug Supply Chain Security Act Update: Revised Dispenser Compliance Policy – Extended to March 1, 2016.

FDA Division of Drug Information: Know the Moment It Happens
The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.

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. 
Today, 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.  
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. 
For more information, please read the guidance located at: DSCSA

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