2021 Office of Compliance Annual Report Underscores Agency Successes in Public Health The Office of Compliance in FDA's Center for Drug Evaluation and Research is pleased to present the office's 2021 Annual Report. This report highlights the Office of Compliance's key initiatives in 2021 that had a direct impact on patient safety, including our efforts to help address the COVID-19 pandemic. In addition to focusing on COVID priorities, the office's work also addressed the opioid crisis, compounded drug quality, drug supply chain security, fraudulent and unsafe drugs, and numerous other priorities throughout 2021. Over the course of 2021, the Office of Compliance focused on efforts to shield patients and consumers from unsafe, ineffective, and poor-quality drugs, including unsafe hand sanitizers and products fraudulently claiming to prevent, treat or cure COVID-19. The office also contributed to the pandemic response by taking action to increase access to critical medicines needed to treat patients with COVID-19, such as albuterol, oxygen and propofol, and to support the development of new therapeutics. The report describes the use of alternative tools when the pandemic prevented on-site inspections; a reorganization to strengthen oversight of drug compounding; and numerous efforts to rid the market of fraudulent, poor quality and unsafe drugs. The accomplishments in 2021 demonstrate the office's unwavering commitment to shield patients from poor quality, unsafe and ineffective drugs. We look forward to continuing our mission in 2022. |
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