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GUIDANCE DOCUMENT

Product Identifiers under the Drug Supply Chain Security Act - Questions and Answers September 2018

Download the Draft Guidance Document
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2018-D-3175
Issued by:
Guidance Issuing Office
Office of Medical Products and Tobacco, Center for Drug Evaluation and Research
Office of Medical Products and Tobacco, Center for Biologics Evaluation and Research

This draft guidance  is intended  to address anticipated questions  regarding  product identifiers that are required  under section 582 of  the Federal Food,  Drug, and Cosmetic  Act (FD&C  Act) (21 U.S.C. 360eee-1), as amended by the Drug Supply  Chain  Security  Act (DSCSA) (Title II of Public Law 113-54) for packages and homogenous cases of certain drug products.

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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-3175.