OTC Medicines

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Strategic Priorities
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Providing Access to Products in Underserved Communities: CHPA Product Donation Program

CHPA is uniquely positioned to provide access to OTC medicines and dietary supplements in nearly every category that can be donated and customized to the needs of underserved communities. Our product donation initiative is an ongoing effort to support these communities. So far, CHPA member companies have donated 70,000 products to people in need.

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Risks Associated with use of Ipecac Syrp as OTC Poison Treatment
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Sunscreen in the States

While a small select group have raised concerns about certain sunscreen ingredients, banning or restricting common UV filters could negatively impact public health.

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Guidelines for Unsolicited Consumer Sampling of Nonprescription Medicines

The purpose of these guidelines is to catalog and strengthen standards of care that have evolved in the practice of providing unsolicited free samples of OTC medicines to consumers to promote their products.

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Critical Ingredients & Chemicals

Federal oversight by the FDA ensures that ingredients and chemical additives used in vital healthcare products available to consumers, like nonprescription drugs, dietary supplements, and medical devices, routinely undergo the most rigorous safety evaluations.

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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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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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Dextromethorphan (DXM) in the States

Dextromethorphan serves as a safe, effective antitussive ingredient in many critical OTC cough and cold formulations. While reasonable age restrictions may curb adolescent misuse without limiting adult access, lawmakers should refrain from unnecessary additional barriers. Targeted age controls strike the right balance between safety and availability.

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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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