U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. About FDA
  3. FDA Organization
  4. Center for Drug Evaluation and Research (CDER)
  5. CDER Offices and Divisions
  6. Office of Compliance
  1. CDER Offices and Divisions

Office of Compliance

Who We Are:

The Office of Compliance (OC) shields patients from poor quality, unsafe, and ineffective drugs through compliance strategies and risk-based enforcement actions. OC makes strategic and risk-based decisions that are guided by law and science to foster global collaboration, promote voluntary compliance and takes decisive and swift actions to protect patients.

Office of Compliance 2023 Annual Report Cover

Office of Compliance Annual Report FY 2023 (PDF - 8 MB)

What We Do:

  • Address patient health risks that arise from violations of FDA regulations and law. Develop risk-based enforcement and communication strategies to reduce and prevent patient harm associated with these violations.
  • Work to protect consumers from unsafe compounded drugs.
  • Protect the integrity of the legitimate drug supply chain and minimize consumer exposure to dangerous products marketed outside the legitimate supply chain.
  • Monitor the quality of human drugs through facility inspections, product testing, and other pre- and postmarket compliance activities.
  • Ensure drugs in FDA approval system have reliable evidence of safety and effectiveness, human subjects in clinical trials are protected, and drugs meet postmarket safety requirements.
  • Develop policies and compliance strategies to help ensure that over-the-counter and prescription drugs are properly labeled and meet drug approval requirements.
  • Coordinate evaluation and classification of drug recalls, and work with FDA offices globally to implement recalls.
  • Monitor and assist with alleviation of drug shortages involving compliance issues.
  • Provide support and guidance on developing potential investigations and regulatory actions to FDA offices around the world.
  • Maintain the electronic drug registration and listing database and work to ensure the information in the database is up to date and accurate.

Organization:

For More Information:

Contact Us:

Email: CDERCompliance@fda.hhs.gov

Phone: 301-796-3100
Fax: 301-847-8747

Office of Compliance
10903 New Hampshire Avenue
Bldg. 51, Rm 5271
Silver Spring, MD 20993-0002



Back to Top