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Office
of Drug Evaluation V
Division of Over-the-Counter (OTC)
Drug Products
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
Phone: (301) 827-2222
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FAX: (301) 827-2315 |
Mailing
address: FDA, CDER Document Control Room 5600 Fishers
Lane (HFD-560) Rockville, MD 20857 |
Delivery
service address: FDA, CDER,
DOTCDP Document Control Room 9201 Corporate Blvd. (HFD-560) Rockville, MD 20850 |
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FDA/Center for Drug Evaluation and
Research
Last Updated: October
15, 2004
Originator: OTCOM/DLIS
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