- Docket Number:
- Issued by:
Guidance Issuing OfficeOffice of Regulatory AffairsCenter for Biologics Evaluation and ResearchCenter 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 . . . ."
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2014-D-0609.