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- Docket Number:
- FDA-2018-D-0338
- Issued by:
-
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research
The Drug Supply Chain Security Act (DSCSA) (Title II of Public Law 113-54) 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. Many of the terms used in these requirements are defined in section 581 of the FD&C Act (21 U.S.C. 360eee).
Submit Comments
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:
Dockets Management
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-0338.
Fonte/Source: http://www.fda.gov/regulatory-information/search-fda-guidance-documents/definitions-suspect-product-and-illegitimate-product-verification-obligations-under-drug-supply
