World of Compliance Module

Drug Product Surveillance Sampling Program

Compliance also manages the Drug Product Surveillance Program, which uses targeted surveys to assess the quality of the nation's drug products. Compliance surveys both domestic and foreign drug products and APIs. Again, using a risk-based management system to identify domestic and foreign drug products and APIs that expose consumers to the highest risk, OC selects specific drug products for collection and sampling. The agency's district laboratories then analyze the targeted products for conformity with applications, compendial standards or manufacturers' specifications. In addition to ensuring the quality of the sampled products, the program benefits public health by:

• Promoting public confidence in the quality of the nation's drug supply
• Maintaining surveillance of newly approved drugs and the industry to ensure compliance with the current good manufacturing regulations
• Identifying potential counterfeit products
• Identifying methodology and emerging drug quality problems