FDA Takes Efforts to Improve Quality of Compounded Drugs From Outsourcing Facilities

Compounded drugs  can serve an important role in meeting patients’ medical needs that cannot be met by an FDA-approved drug. Outsourcing facilities, a significant part of the industry producing compounded drugs used by hospitals, clinics, providers, and other health care systems, have rapidly evolved since the passage of the Drug Quality and Security Act (DQSA) in 2013. Although compounded drugs can fill an important role for patients and the FDA recognizes the need to preserve access to these products, they may also present a greater risk to patients because, among other things, they are not required to undergo the agency’s premarket review for safety, effectiveness and quality. These risks have become evident during inspections of outsourcing facilities when the agency has found concerning production practices that have resulted in recalls of compounded drug products and enforcement action against some firms.

To help mitigate such issues, the FDA has been working to develop novel approaches to engage outsourcing facilities and help them produce the highest quality products. To this end, today, the agency is announcing the Compounding Quality Center of Excellence – an initiative designed to enhance collaboration among and provide educational programs for outsourcing facilities aimed at improving the overall quality of compounded medicines.

“By providing comprehensive, accessible learning tools, we will support outsourcing facilities in reliably producing high-quality compounded products that meet FDA’s standards. While engagement is voluntary, this initiative will provide an increased awareness and understanding of common issues and provide innovative ways to address challenges outsourcing facilities may face,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “The FDA looks forward to ongoing engagement with outsourcing facilities.”

The Center of Excellence, supported by a contract awarded by the FDA to Deloitte, will have three main areas of focus: in-person and online education and trainings; a conference to give outsourcing facilities, stakeholders and the agency the opportunity to exchange ideas and best practices; and market research to help inform the agency on key issues faced by outsourcing facilities.