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GUIDANCE DOCUMENT

Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy Guidance for Industry September 2018

Download the Final Guidance Document Read the Federal Register Notice
Final
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This draft guidance describes FDA’s intention with regard to the enforcement of certain requirements related to product identifiers under the Drug Supply Chain Security Act. Specifically, this draft guidance addresses the requirement in section 582(b)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee-1(b)(2)) that manufacturers “affix or imprint a product identifier to each package and homogenous case of a product intended to be introduced in a transaction into commerce” beginning not later than November 27, 2017. A drug product is misbranded if it fails to bear the product identifier as required by 21 section 582 of the FD&C Act.

Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

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 comments should be identified with the title of the guidance.

 
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