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
Requirements for All OTC Products
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OTC Requirements

While the two regulatory pathways for bringing an over-the-counter (OTC) drug to market, the New Drug Application (NDA) process and OTC Monograph Process, are quite different, there are certain requirements that apply to all OTC products regardless of the regulatory pathway used.

Let's take a brief look into these requirements and how they will affect the marketing of your OTC drug. Review the graphic to the right.
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