FDA's Guidance on Track & Trace Standards

The FDA published the final guidance on standards for the interoperable exchange of track & trace information for certain human prescription drugs. The guidance finalizes the revised draft guidance of the same title, DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs, issued in July 2022. The provisions apply to trading partners (i.e., manufacturers, wholesale distributors, dispensers, and repackagers) who engage in transactions of products (i.e., a prescription drug in a finished dosage form for administration to a patient without requiring substantial further manufacturing, such as capsules, tablets, and lyophilized products before reconstitution). In addition, the DSCSA requires that the trading partners who engage in transactions of products meet the applicable requirements for being authorized trading partners.

Background

The guidance identifies the standards necessary to facilitate adoption of secure, interoperable, electronic data exchange among actors of the pharmaceutical distribution supply chain, and clarifies the trading partners, products, and transactions subject to such standards. It reflects the enhanced drug distribution security requirements of the FD&C Act that will go into effect on 27 November 2023, including that only electronic methods of product tracing will be permitted and verification of product at the package level will be required, unless a waiver, exception, or exemption applies. The enhanced drug distribution security requirements for trading partners include adherence to standards established by FDA for the exchange of transaction information and transaction statements (as defined in section 581 of the FD&C Act) in a secure, interoperable, electronic manner.

EPCIS & GS1 Standards

FDA recommends that trading partners use the Electronic Product Code Information Services (EPCIS) standard to provide and maintain the data associated with transaction information and transaction statements. EPCIS is a global GS1 standard that allows trading partners to capture and share information about products as they are transacted through the supply chain. "Use of EPCIS can support and enable electronic and interoperable interfaces used by trading partners to help ensure compliance with DSCSA requirements and is compatible with a range of different technological approaches", FDA says. The agency concludes that EPCIS is an appropriate globally recognized standard, and there is considerable agreement among stakeholders that EPCIS is a suitable standard to adopt for the enhanced drug distribution security requirements.

More information is provided in FDA's final guidance DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs and on FDA’s Drug Supply Chain Security Act Law and Policies web page.