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  1. Center for Drug Evaluation and Research | CDER

Office of Nonprescription Drugs

The Office of Non-Prescription Drugs (ONPD) consists of two review divisions: The Division of Nonprescription Drugs I and 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. OTC drug products are those drugs that are available to consumers without a prescription. There are more than 80 therapeutic categories of OTC drugs, ranging from acne drug products to weight control drug products. As with prescription drugs, CDER oversees OTC drugs to ensure that they are properly labeled and that their benefits outweigh their risks.  

OTC drugs generally have these characteristics:

  • their benefits outweigh their risks
  • the potential for misuse and abuse is low
  • consumer can use them for self-diagnosed conditions
  • they can be adequately labeled
  • health practitioners are not needed for the safe and effective use of the product

Director: Theresa Michele, M.D. (Acting)
Deputy Director: Karen Mahoney, M.D. (Acting)

Regulatory Operations

Director, Project Management Staff: Celia Peacock (Acting)

Contact Us

Mailing Address: 
Office of Nonprescription Drugs
10903 New Hampshire Avenue WO22 Stop 5411
Silver Spring MD 20993

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