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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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Background Summary: Anticaries Test Methods

Since the Final Rule was published in 1995, FDA has received six Citizen Petitions (CPs) requesting the addition of alternatives to the animal caries test to the Anticaries Monograph.

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Volatile Organic Compounds

While VOCs can have environmental impacts in aggregate, existing alternatives don’t always provide the consistent therapeutic results needed for OTC products relied upon by millions for. As such, any legislation aimed at further restricting pharmaceutical VOCs must carefully weigh potential unintended consequences on public health.

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Our Initiatives

The Health in Hand Foundationleads influential, innovative educational initiatives that address specific areas where consumers need guidance and support.

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Meetings and Education Calendar

Save the date for upcoming CHPA meetings and events!

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Background Summary: Risks Associated with Codeine-Containing Cough Medicine

This Proposed Safety Administrative Order addresses the GRASE status of codeine, codeine phosphate, and codeine sulfate as antitussive active ingredients.

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