Docket Number:
FDA-2014-D-0609
Issued by:
Guidance Issuing Office
Office of Regulatory Affairs
Center for Biologics Evaluation and Research
Center for Drug Evaluation and Research

This guidance is intended to aid trading partners3,4 (manufacturers, repackagers, wholesale distributors, and dispensers) in identifying a suspect product as defined at section 581(21) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee(21)) and terminating notifications. It does not establish any rights for any person and, with the exception of section IV.B, it is not binding on FDA or the public. With respect to section IV.B, section 582 of the FD&C Act gives FDA authority to issue binding guidance on the process for terminating notifications of illegitimate product. Specifically, section 582(h)(2)(A) states that FDA "shall issue a guidance document to aid trading partners in the identification of a suspect product and notification termination. Such guidance document shall . . . set forth the process by which manufacturers, repackagers, wholesale distributors, and dispensers shall terminate notifications in consultation with the Secretary regarding illegitimate product . . . ."

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All written comments should be identified with this document's docket number: FDA-2014-D-0609.