FDA Issues FY2021 Report on the State of Pharmaceutical Quality: The Office of Pharmaceutical Quality (OPQ) within FDA’s Center for Drug Evaluation and Research has published the fiscal year 2021 Report on the State of Pharmaceutical Quality which summarizes various measures of the pharmaceutical industry’s ability to deliver quality drugs to U.S. patients and consumers. This report contains outcomes of OPQ’s quality surveillance efforts and selected indicators and trends that provide insights into drug and manufacturing site quality.
FDA uses the State of Pharmaceutical Quality to inform research, regulatory decision-making, and surveillance activities across more than 4,000 manufacturing sites and more than 150,000 drug products. OPQ shares the information in this report so external stakeholders can better understand the quality of the U.S. drug supply. Together, FDA and our stakeholders can strengthen the quality of drugs in the U.S. market and the reliability of global drug manufacturing.