FDA Continues Collaboration with Drug Compounders as Second Anniversary of Compounding Quality Center of Excellence Approaches
Compounded drugs can be a critical treatment option for patients who need them; however, the U.S. Food and Drug Administration does not review these drugs for safety, effectiveness, or quality before they are marketed for patient use, and they can pose serious risks. One of the best ways to protect patients and minimize the risks presented by poor-quality compounded drugs is for the agency to work with compounders to foster higher quality products.
For this reason, the FDA established the Compounding Quality Center of Excellence (COE) in December 2019 to engage proactively and collaboratively with outsourcing facilities, pharmacy compounders, and other stakeholders to improve the quality of compounded prescription drugs for human use. An outsourcing facility is defined as a facility at one geographic location or address that is engaged in the compounding of sterile drugs, has elected to register as an outsourcing facility, and complies with all of the requirements of section 503B of the Food, Drug, and Cosmetic Act. The COE enables the FDA to better understand the challenges compounders face, while also providing compounders with knowledge and experience to help implement robust quality management systems to enhance patient safety.
The COE supports the overall quality of compounded drugs through three main areas – training, market research, and outreach, featuring an annual conference. This year’s virtual conference will take place September 14-15 and highlight the importance of working together to improve product quality and quality culture in the compounding industry.
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