Federal Programs

DSCSA Update: Compliance Policy Implementation Delayed Until March

The Tennessee Pharmacists Association (TPA) is providing the following information as an update to members about the recent Drug Supply Chain Security Act (DSCSA) implementation Compliance Policy. TPA received the information below from the Division of Drug Information (DDI), a division of the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (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

Please check http://bit.ly/fda-dscsa for the latest activities on the DSCSA.

TPA will continue to monitor these developments and update members as further information becomes available.