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  1. Office of Medical Products and Tobacco

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.

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