In its document, the regulator explains how dispensers in the pharmaceutical distribution supply chain should comply with the FDCA’s product tracing information provisions, which were added by the DSCSA, pushing back compliance from July to November.
Section 202 of the DSCSA, which was signed into law in 2013 and added new sections to the FDCA, laid out new product tracing definitions and requirements. Beginning in 2015, trading partners must provide subsequent purchasers with product tracing information when it comes to transactions that involve certain prescription drugs. They’re also required to obtain the tracing information and maintain it for at least six years following the transaction date.
While the product tracing requirements of the FDCA came into effect for dispensers as of July 1, some dispensers voiced concern that electronic systems used for the exchange, capture and maintenance of information couldn’t be operational in time. In its guidance, the FDA notes it recognizes that some dispensers may need more time to comply, and thus won’t take action before Nov. 1. More specifically, no action will be taken against dispensers who before Nov. 1 accept ownership of product without receiving tracing information prior to or at the time of the transaction or don’t collect and maintain the information.
The guidance concludes by advising dispensers to work with previous product owners to receive product tracing information if they’ve not received it before or at the time of the transaction.