U.S. Food and Drug Administration
Protecting and Promoting Your Health
Small Business Assistance
Center for Drug Evaluation and Research
Bringing an Over-the-Counter (OTC) Drug to Market
OTC vs. Prescription
What Is an OTC Drug?

Let's start with the basics. What exactly is an over-the-counter (OTC) drug?

There are hundreds of OTC drugs at your local pharmacy. Many items you may think are cosmetics, dietary supplements, or medical devices, which have their own regulatory requirements, may also be classified as "drugs."

The term "drug" is a legal one. As described in the Federal Food, Drug, and Cosmetic Act:

A drug is an article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or an article (other than food) intended to affect the structure or function of the human body and/or an article intended for use as a component of such an article.

What do we mean by "intended" or "intended for use," and why is this important?

Screenshot of the Federal Food, Drug, and Cosmetic Act on FDA's Web site.
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