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.
The in-person trainings will target registered outsourcing facilities and, as space allows, pharmacies that are considering becoming outsourcing facilities, by focusing on key aspects of current good manufacturing practice (CGMP) and FDA policies. Registration is now open for the March courses with additional courses scheduled throughout 2020. Participants will have the opportunity to earn continuing education credits while enhancing their understanding of necessary procedures and guidelines.
Topics for the in-person trainings will include sterile compounding, environmental monitoring, investigating quality issues, initiating corrective and preventive actions and proper cleanroom design and practices. Portions of this training will be in a laboratory environment to enhance hands-on learning. These trainings will be offered in small settings with free registration for outsourcing facility personnel to encourage participation.
The online education programs will also focus on key aspects of CGMP, as well as other facets of drug compounding. These courses will be free for participants and will provide continuing education credits.
As part of this new initiative, the FDA will also host a Center of Excellence conference in September 2020 in Dallas, Texas that will provide a forum for outsourcing facilities and related stakeholders to offer their feedback on policies and regulatory issues.
Market research will be another key area of the Center of Excellence’s work as it gets underway. With this information, the agency can better understand the possible barriers and opportunities outsourcing facilities may encounter in several areas such as business growth and viability, adhering to CGMP regulations and interactions with the FDA. This research will provide a better analysis of the outsourcing facility sector, so the agency can further enhance the Center of Excellence to make it as valuable as possible for all stakeholders.
Through its training, collaboration and stakeholder engagement, the Center of Excellence will help support outsourcing facilities’ efforts to meet quality standards with the hope of reducing risks these products may pose to the public health.