- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Drug Evaluation and Research, Office of Regulatory Policy
This revised draft guidance addresses the verification systems that manufacturers, repackagers, wholesale distributors, and dispensers must have in place to comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Drug Supply Chain Security Act (DSCSA). Specifically, this draft guidance covers the statutory verification system requirements that include the quarantine and investigation of a product determined to be suspect and the quarantine and disposition of a product determined to be illegitimate. It also addresses the requirement for notification to the FDA of a product that has been cleared by a manufacturer, repackager, wholesale distributor, or dispenser after a suspect product investigation because it is determined that the product is not an illegitimate product. Finally, this draft guidance addresses the requirement for responding to requests for verification and processing saleable returns.
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-2018-D-3462.