US FDA: Two new Track and Trace guidance docs

The FDA has released two new guidances for interpreting track and trace requirements: Standardization of Data and Documentation Practices for Product Tracing Guidance for Industry, and Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act.
The guidance document on data and documentation elaborates on the standards for the interoperable exchange of transaction information, transaction history, and transaction statements required by section 582 of the Federal Food, Drug, and Cosmetic Act. The other document defines suspect product and illegitimate product as they appear in section 581 (Serialization Countdown, 5 March 2018).
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Click here to download the Draft Guidance on Standardization of Data and Documentation Practices for Product Tracing (170 kB).
Click here to download the Draft Guidance for Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act (282 kB).

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