DSCSA T3 Data Standardization and Documentation Practices

The FDA released the draft guidance, which provides a significant amount of detail regarding the standardization of product tracing information, its specific data elements, and recommended documentation documentation practices that trading partners may utilize to satisfy their product tracing requirements. 

This guidance supplements the DSCSA Standards for the Interoperable exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs: How to Exchange Product Tracing Information guidance released in November 2014.

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