FDA’s Center for Drug Evaluation and Research’s (CDER) Office of Compliance

By Mark Land, M.S., RAC, AAHP President

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.

OC has multiple touch points with the homeopathic industry through the drug listing system, review of establishment inspection reports, prioritizing future inspections, and labeling reviews. OC representatives have been frequent presenters at AAHP events.

OC is organized into six offices:

  • Office of Compounding and Quality Compliance
  • 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

These six offices work to:

  • 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.

In other articles in this edition of AAHP Network News, we report on the work of the Office of Compliance and their new director Jill Furman.

For more information and access to past annual reports, visit their webpage here.