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

Issue Date: September 1, 2009
Issued by: Center for Drug Evaluation and Research
Topic(s): Over-the-Counter Drugs
Status: Final

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

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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