Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act Guidance for Industry

The Drug Supply Chain Security Act ( DSCSA ) amended the Federal Food, Drug, and Cosmetic Act ( FD&C Act ) to establish requirements for product  tracing, verification, and product identification for certain drug products that are distributed in  the United States.

FDA is issuing this guidance to interpret the terms used in the definition of suspect product set forth in section 581(21) of the FD&C Act, and the definition of illegitimate product set forth in section 581(8) of the FD&C Act, in order to assist trading partners in meeting verification obligations (including notification) under sections 582(b)(4), (c)(4), (d)(4), and (e)(4), respectively.

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