Identifying Trading Partners Under the Drug Supply Chain Security Act

5 July 2022 — FDA issued the draft guidance for industry. Submit comments by 05 September 2022.

The FDA is issuing this guidance to assist industry and State and local governments in understanding how to categorize the entities in the drug supply chain in accordance with the Drug Supply Chain Security Act (DSCSA). This guidance revises the Agency’s draft guidance for industry Identifying Trading Partners Under the Drug Supply Chain Security Act (August 2017) to address the status of some entities as trading partners (e.g., private-label distributors, salvagers, and returns processors and reverse logistics providers), provide clarification on certain drug distribution scenarios, and address the interpretation of section 582(a)(7) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which discusses third-party logistics providers (3PL) licensure status prior to the effective date of the forthcoming regulations establishing licensure standards.

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