FDA: DSCSA Implementation: Product Tracing Requirements for Dispensers
This guidance addresses the readiness of dispensers in the pharmaceutical distribution supply chain to comply with the provisions in section 582 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee-1 related to the exchange of transaction information, transaction history, and transaction statements (product tracing information). For dispensers, requirements for the tracing of products through the pharmaceutical distribution supply chain under section 582 of the FD&C Act go into effect on July 1, 2015. This guidance announces the FDA’s intention with regard to enforcement of the product tracing information requirements under section 582 of the FD&C Act. As described below, FDA does not intend to take action against dispensers who, prior to November 1, 2015, accept ownership of product without receiving product tracing information, prior to or at the time of a transaction, as required by section 582 of the FD&C Act, or do not capture and maintain the product tracing information, as required by section 582 of the FD&C Act. Section IV of this guidance provides further detail about the scope of this compliance policy and FDA’s expectations for dispensers and trading partners involved in transactions with dispensers.