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GUIDANCE DOCUMENT

Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act Guidance for Industry Guidance for Industry March 2023

Final Level 1 Guidance
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).


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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.

 
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