Over-the-Counter Drug Products; Safety and Efficacy Review

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The Food and Drug Administration (FDA) is announcing a call for data for certain categories of ingredients in over-the-counter (OTC) drug products that are eligible for the original OTC drug review but have not been reviewed by FDA to date. FDA will review the submitted data and information as part of its ongoing review of OTC drug products to determine whether these ingredients and products are generally recognized as safe and effective (GRAS/E) for their labeled uses. This document also requests the identification of other categories of OTC drug products that were in the marketplace when the OTC drug review began on May 11, 1972, or that were marketed before December 4, 1975, and describes FDA's general regulatory policy governing the marketing of these OTC drug products during the pendency of this review.