Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required

• Date: December 01, 2009
• Source: www.fda.gov

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. In particular, this document covers the following topics: (1) the meaning of domestic address for purposes of the labeling requirements of section 502(x) of the Act, (2) FDA’s recommendation for the use of an introductory statement before the domestic address or phone number that is required to appear on the product label under section 502(x) of the Act, and (3) FDA’s intent regarding enforcing the labeling requirements of section 502(x) of the Act

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