Office of Nonprescription 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
For an overview on how OTC drug products are regulated by FDA, please
see the presentation:
OTC 101, (PowerPoint) 4/2005
Immediate Office:
Phone: 301-796-2060 Fax: 301-796-9899
Division of Nonprescription Clinical Evaluation
Phone: 301-796-2080
Division of Nonprescription Regulation Development
Phone: 301-796-2090
Mailing address (Postal Service Only):
DHHS/FDA/CDER/OND
Office of Nonprescription Products
10903 New Hampshire Avenue WO22 Stop 5411
Silver Spring MD 20993
Delivery address (UPS, FedEx, Curriers, Private Delivery Companies):
DHHS/FDA/CDER/OND
Office of Nonprescription Products
10903 New Hampshire Ave WO22 Stop 5411
Silver Spring MD 20903
Regulatory Submissions (Central Document Room; for IND & NDA Submissions with Assigned Numbers only):
DHHS/FDA/CDER/ONP
5901-B Ammendale Road
Beltsville, MD 20705 - 1266
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Last updated: June 7, 2006 |