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GUIDANCE DOCUMENT

Wholesale Distributor Verification Requirement for Saleable Returned Drug Product—Compliance Policy Guidance for Industry Guidance for Industry September 2019

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2019-D-4212
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research
Office of Regulatory Affairs

This guidance is intended for wholesale distributors who must verify the product identifier upon receipt of a returned product that the wholesale distributor intends to further distribute as required under section 582(c)(4)(D) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee-1(c)(4)(D)). This guidance addresses the readiness of wholesale distributors to comply with the provisions in section 582 of the FD&C Act related to the verification of saleable returned drug products. The requirement under section 582(c)(4)(D) for wholesale distributors to verify saleable returned drug products prior to redistribution goes into effect on November 27, 2019.

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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-2019-D-4212.

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