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GUIDANCE DOCUMENT

Collecting and Providing 702(b) Portions of FDA Official Samples Draft Guidance for Industry January 2022

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2021-D-0593
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Veterinary Medicine
Office of Inspections and Investigations
Center for Biologics Evaluation and Research
Human Foods Program

This draft guidance is intended to assist FDA staff and industry with issues and questions related to the requirements for FDA to collect and provide portions of official samples under section 702(b) of the Federal Food, Drug, & Cosmetic Act (FD&C Act) and its implementing regulation in Title 21 Code of Federal Regulations (CFR) section 2.10 (21 CFR 2.10).  The contents of this document do not have the force and effect of law and are not meant to bind the public in any way, unless specifically incorporated into a contract. This document is intended only to provide clarity to the public regarding existing requirements under the law. FDA guidance documents, including this guidance, should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required.

Submit Comments

Submit Comments Online

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-2021-D-0593.

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