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GUIDANCE DOCUMENT

Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Questions and Answers September 2009

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2007-D-0429
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This document is intended to assist industry in complying with the labeling requirements of the Dietary Supplement and Nonprescription Drug Consumer Protection Act (Public Law 109-462, 120 Stat. 3469). The statute created a new section 502(x) in the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 352(x)). These requirements apply to manufacturers, packers, and distributors of nonprescription (over-the-counter (OTC)) human drug products marketed without an approved application.
 

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All written comments should be identified with this document's docket number: FDA-2007-D-0429.

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