FDA Delays Product Tracing Requirements for Dispensers

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The agency gives a limited reprieve to dispensers but requires other trading partners to provide product tracing information.


On June 30, 2015, FDA issued guidance for immediate implementation stating the agency’s intentions regarding Drug Supply Chain Security Act (DSCA) product-tracing information requirements for dispensers in the drug distribution supply chain under the Federal Food, Drug, and Cosmetic Act (FD&C Act), which go into effect July 1, 2015. The guidance states that, in response to requests for more time, the agency “does not intend to take action against dispensers who, prior to November 1, 2015, accept ownership of product without receiving the product tracing information.” The requirements are part of section 582 of the FD&C Act and relate to “the exchange of transaction information, transaction history, and transaction statements (product tracing information).”


However, FDA states in the guidance that the compliance policy does not extend to the requirements that “other trading partners (manufacturers, wholesale distributors, and repackagers) provide product tracing information to dispensers. In addition, this compliance policy does not extend to transactions in which dispensers must provide the subsequent owner with product tracing information, including transaction history … Prior to November 1, 2015, FDA also does not intend to take action against dispensers who do not capture and maintain the product tracing information, as required by section 582(d)(1)(A)(iii) of the FD&C Act. This compliance policy does not extend to other requirements of the FD&C Act, including those in section 582, such as verification related to suspect and illegitimate product (including quarantine, investigation, notification and recordkeeping) and requirements related to engaging in transactions only with authorized trading partners.”

Source: FDA