Small Business Assistance

Over-the-Counter (OTC) Drug Product Review Process

Over-the-counter drugs are defined as drugs that are safe and effective for use by the general public without a prescription.

• Over-the-Counter Drug Product Review Process.  An interactive chart that provides an overview of CDER's over-the-counter review process.

• Division of OTC Drug Products Home Page. Links to information on new OTC labeling and warning, and an index of significant OCT drug Federal Register publications.

• Frequently Asked Questions on the Regulatory Process of OTC Drugs (4/5/2004)

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FDA/Center for Drug Evaluation and Research
Last Updated:  April 5, 2004
Originator: OTCOM/DML
HTML by  PKS, SJW