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U.S. Department of Health and Human Services

About FDA

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Regulation of Nonprescription Products

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

 

Immediate Office (ODE IV):
Phone:  301-796-2060 Fax:  301-796-9899

Division of Medical Imaging Products
Phone:  301-796-2050
 

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 Drug Evaluation IV
10903 New Hampshire Avenue WO22 Stop 5411
Silver Spring MD 20993

Delivery address (UPS, FedEx, Couriers, Private Delivery Companies):
DHHS/FDA/CDER/OND
Office of Drug Evaluation IV
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/ODE IV
5901-B Ammendale Road
Beltsville, MD 20705 - 1266