OTC Medicines

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FDA Announcement of a proposed safety-based Administrative Order (AO) to address dosage strengths of oral, single ingredient, pediatric acetaminophen products. This AO proposal includes the addition of weight and age-based dosing for children under age 12.

CHPA generally supports prohibitions on animal testing while allowing exemptions in select research areas deemed critical to substantiating human health and safety based on federal or state regulator evaluations.

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.

CHPA's member-only weekly report from our State & Local Government Affairs team, reporting on recent legislative activity around the country affecting our industry.

The success of healthcare vending indicates many consumers welcome the affordability and around-the-clock availability these machines provide. As the trend accelerates, people across socioeconomic backgrounds are empowered to conveniently tend to their healthcare needs.

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.

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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