OTC Medicines

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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.

Learn about CHPA's current slate of federal legislative priorities including OTC regulatory reform, dietary supplement regulation modernization, supply chain and product integrity, and more.

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Millions of Americans rely on OTC medicines as an accessible and effective solution for commonly occurring conditions. Learn about the value that OTCs provide to the U.S. healthcare system.

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.

Find information about the classes of drugs available in the United States and how uniformity is enforced across state lines.

Safe use of acetaminophen is a top priority for manufacturers of OTC medicines. Manufacturers work closely with FDA, healthcare provider groups, pharmacist groups, and consumer health advocates to drive safe and responsible use of acetaminophen.

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.

Learn about rules and regulations for structured product labeling of OTC medicines.

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Learn more about the issues CHPA addresses in the OTC medicine, dietary supplement, and consumer medical device industries.

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