The Office of Non-Prescription Drugs (ONPD) consists of two review divisions: The Division of Nonprescription Drugs I and Nonprescription Drugs II. The Immediate office oversees the development, review, and regulation of nonprescription products (marketed under Over-the-counter (OTC) monographs and under NDAs) reviewed in these divisions. OTC drugs play an increasingly vital role in America's health care system.
Director: Theresa Michele, M.D.
Deputy Director: Karen Murry, M.D.
Director of Project Management Staff: Celia Peacock
Food and Drug Administration
Center for Drug Evaluation and Research
Office of Nonprescription Drugs
10903 New Hampshire Avenue WO22 Stop 5411
Silver Spring, MD 20993
Resources For You
- Status of OTC Rulemakings (monographs)
- Regulation of Over-the the-Counter (OTC) Drug Products
- Consumer Information: Safe Use of Over-the-Counter Drug Products
- Over-the-Counter (OTC) Related Federal Register Notices, Ingredient References, and other Regulatory Information
- CDER Small Business Webinar - Sunscreens Marketed Under the OTC Monograph System - September 19, 2011External Link Disclaimer