OTC Medicines

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Analysis of Reportability of Changes to NDA OTC Product Labeling

The CHPA Analysis of Reportability of Changes to New Drug Application (NDA) Over-the-Counter (OTC) Product Labeling Table was developed to assess the reportability of changes to OTC products subject to new drug applications.

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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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FAQs

FAQs About Rx-to-OTC Switch

Learn about the process of transferring FDA-approved prescription medications to nonprescription, over-the-counter status.

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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

FAQs About the OTC Review

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

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