CHPA is the home for responsible members of the consumer healthcare community. We represent leading manufacturers, and the companies that service them, in the area of OTC medicines, dietary supplements, and consumer medical devices.
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.
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.
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.