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U.S. Department of Health and Human Services

About FDA

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Drug Product Sampling Surveillance

The Division of  Compliance Risk Management and Surveillance manages the Drug Product Surveillance Program, which uses targeted surveys to assess the quality of the nation's drug products. The division surveys both domestic and foreign drug products and active pharmaceutical ingredients (APIs). The Post-Market Surveillance Working Group uses a risk-based management system to identify domestic and foreign drug products and APIs that expose consumers to the highest risk. The agency's district laboratories then analyze the targeted products for conformity with applications, compendial standards, or manufacturers’specifications. In addition, the Office of Pharmaceutical Science selects certain products for additional laboratory testing.

Although the primary purpose of the Drug Product Surveillance Program is to ensure the safety of the nation's drug supply, the program also benefits the FDA by 

  • promoting public confidence in the quality of the nation’s drug supply 
  • maintaining surveillance of newly approved drugs and the industry to assure compliance with the current good manufacturing regulations
  • identifying potential counterfeit products 
  • providing information for drug approvals
  • identifying methodology and emerging drug quality problems