CPG on Product Tracing Requirements

[membership level=”0,4″][The content continues for paid members only.] Login or Subscribe [/membership][membership level=”1,5,6,7,8,9,10,11,12″][membership] On July 1, FDA issued a compliance policy guide (CPG) on product tracing requirements as part of its implementation of Title I of the 2013 Drug Supply Chain Security Act (DSCSA) (see IPQ “Monthly Update” January 2014, pp. 13-20). The guidance addresses the readiness of dispensers in the pharmaceutical distribution supply chain to comply with the DSCSA requirements related to product tracing, including the exchange of transaction information, transaction history, and transaction statements. For dispens-ers, the requirements went into effect on July 1, 2015. In the CPG, FDA notes that it does not intend to take action against dispens-ers who, prior to November 1: ● accept ownership of product without receiving product tracing information, prior to or at the time of a transaction, or ● do not capture and maintain the product tracing information. Also provided is further detail about the scope of the CPG and the agency’s expectations for dispensers and trading partners involved in transactions with dispensers.
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