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.
- Office of Drug Security, Integrity, and Response
- Office of Manufacturing Quality
- Office of Program and Regulatory Operations
- Office of Scientific Investigations
- Office of Unapproved Drugs and Labeling Compliance
For More Information
- Office of Compliance Annual Report 2017 (PDF - 4 MB)
- Office of Compliance Annual Report 2018 (PDF - 1.35 MB)
Office of Compliance
10903 New Hampshire Avenue
Bldg. 51, Rm 5271
Silver Spring, MD 20993-0002