FDA issues revised draft Guidances for Track and Trace

Recommendation

5/6 June 2024

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The Drug Supply Chain Security Act (DSCSA) distribution security requirements will come into effect in November next year. To help trading partners comply with the DSCSA, the U.S. Food and Drug Administration (FDA) recently issued revised versions of two previously published draft guidances. Comments can be submitted to FDA by 5 September 2022.

The DSCSA outlines requirements for electronic track & trace systems for prescription drugs when distributed in the United States. In addition, it is also required that trading partners of manufacturers, wholesale distributors, dispensers, and repackagers must meet the applicable requirements for being “authorized trading partners”.

Guidance on DSCSA Standards for Track & Trace

The revisions described in this guidance update the policy described in the November 2014 draft guidance, including that

• paper-based methods of product tracing will no longer be permitted,
• verification of product at the package level will be required, unless a waiver, exception, or exemption applies,
• trading partners should use GS1's Electronic Product Code Information Services (EPCIS) standard for electronic data associated with transaction information.

Guidance on Identifying Trading Partners Under the DSCSA

The agency is issuing this guidance to assist industry and State and local governments in understanding how to categorize the entities in the drug supply chain. The guidance revises FDA’s August 2017 draft guidance to address

• the status of some entities as DSCSA trading partners, including private-label distributors, returns processors and reverse logistics providers,
• the applicability of section 582(a)(7) of the FD&C Act related to third-party logistics providers (3PL) licensure status prior to the effective date of the forthcoming regulations establishing licensure standards.

For more information please see the two FDA draft documents DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs and Identifying Trading Partners Under the Drug Supply Chain Security Act.