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The advertising of nonprescription, over-the-counter medicines helps acquaint the public with these products and must be truthful, not misleading, and must meet high standards reflecting the nature of the product advertised.

The objective of this guideline is to define the minimum stability data package to support the commercial distribution of OTC monograph drug products in the United States per climatic zone.

Due to the wide variety of changes that may be encountered after an OTC monograph drug is marketed, it is impossible to address stability requirements for all changes in this guideline. However, guidance from the examples provided here can be used in the decision-making process.

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.