OTC Medicines

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Voluntary Codes and Guidelines

This white paper provides guidance for the evaluation and reporting of impurities in OTC monograph drug products formulated as topicals and topical rinses. This document serves as CHPA's member company consensus on this complex issue.

Submission

CHPA and its members, the U.S. manufacturers and distributors of OTC medicines and nutritional supplements, recognize the efforts of the FDA to further develop methodologies and techniques for characterization of nanomaterials for drug applications.

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Current good manufacturing practices establish uniform standards to ensure quality throughout the manufacturing, packaging, labeling, and holding of OTC medicines and dietary supplement products.

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The CHPA Educational Foundation is dedicated to helping consumers lead happier, healthier lives by providing information and guidance on how to safely use, store, and dispose of OTC medicines, dietary supplements, and consumer medical devices.

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Find information about standards and regulations for OTC drug advertising in the United States.

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