OTC Medicines

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Guidelines for the Stability Testing in Support of Changes to Nonprescription (OTC) Monograph Drug Products Not Regulated by an NDA/ANDA

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.

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Preventing Illegal Meth Production

CHPA is committed to advancing solutions to illegal sales that penalize criminals and ensure law-abiding consumers continue to have access to a wide range of treatment options, including nonprescription medicines containing PSE.

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FAQs About the OTC Review

Learn about the OTC review process, drug monographs, and time and extent applications.

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