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U.S. Department of Health and Human Services

About FDA

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Drug Quality Reporting System (DQRS)

Since the early 1970s, the FDA has operated the Drug Quality Reporting System (DQRS), which encourages health care professionals to voluntarily report observed or suspected defects or quality problems with marketed drug products. The agency receives reports through the MedWatch Program.

The Division of Compliance Risk Management and Surveillance evaluates and prioritizes drug quality reports in order to identify and follow-up on significant health hazards through assignment and review of investigative reports. Drug quality reports are also used to identify industry trends associated with pharmaceutical manufacturing, packaging, and labeling. The division shares the data with the U.S. Pharmacopeia to enhance compendial standards for drug products.

The division also reviews and identifies potential bioequivalence problems with generic medications. Follow-up actions are coordinated with the Therapeutic Inequivalence Action Coordinating Committee.  The division also evaluates drug quality problems or adverse reaction reports received through the Government-Wide Quality Assurance Program and coordinates follow-up actions with the Division of Medical Products Quality Assurance.

Related Resources

  • Drug Quality Reporting System  (updated 1/18/2007) This presentation is an overview of the DQRS, including background, objectives, responsibilities, and reporting.