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
Regulation Overview
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OTC Drug Review

The OTC Drug Review is an important part of drug regulation. The OTC Drug Review's focus is to enhance the safety, effectiveness, and appropriate labeling of drugs sold without a prescription from a licensed healthcare prescriber. It establishes a way for OTC drug products to come into market without individual FDA evaluation and approval.

So, how was the OTC Drug Review started? Let's take a look back at FDA history, and look at the system's inception and development.

Select the timeline to learn more.

1906 1938 1962 1972
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