FDA Does Not Intend to Enforce Product Tracing Requirements Related to Dispensers’ Receipt and Maintenance of Product Tracing Information Until November 1, 2015. It Did Not Delay Dispenser Requirements With Respect to Product Verification and Authorized Trading Partners.

Summary -

On June 30, 2015, the Food and Drug Administration (FDA) issued guidance for the pharmaceutical industry regarding the implementation of the Drug Supply Chain Security Act’s (DSCSA) product tracing requirements for dispensers. In this guidance, FDA announced that it “does not intend to take action against dispensers” that fail to capture and then maintain product tracing information from their trading partners prior to November 1, 2015. The obligation for dispensers to capture and maintain this information takes effect on July 1, 2015.