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

Not all OTC drugs require the NDA process. In fact, the OTC Drug Review establishes a way for OTC drug products to come into market without individual FDA evaluation and approval if they meet FDA's established conditions for general recognition of safety and effectiveness (GRASE).

If a product deviates from the allowed conditions, then the drug product is likely considered a new drug and will require an NDA to be legally marketed.

Mattie holding a bottle of medicine with a text bubble next to her: Does this OTC drug require the NDA process?
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