Office of Drug Evaluation V
Division of Over-the-Counter (OTC) 
Drug Products

• Who We Are

• What We Do

• Consumer Information: Safe Use of Over-the-Counter Drug Products

• Industry Information: Full-text OTC-Related Federal Register Notices, Ingredient References, and other Regulatory Information (9/8/2004)

• Health Professional Information: Online Reporting of Problems with Medical Products and Other Safety Information

• Related Information

Introduction

Over-the-counter (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

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FDA/Center for Drug Evaluation and Research
Last Updated: August 24, 2004
Originator: OTCOM/DLIS
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