By: Donald D. Ashley, JD, Director of the Office of Compliance, Center for Drug Evaluation and Research (CDER) and Patrizia Cavazzoni, MD, Director of CDER
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.
While many outsourcing facilities aim to meet quality standards for compounded drugs, the FDA has found that some are not consistently meeting these standards, which can result in poor quality compounded drugs that can harm patients. The COE training program provides trainings on topics such as current good manufacturing practice (CGMP), which are minimum requirements for the methods, facilities, and controls used in the manufacturing, processing, packing, and holding of drug products. Additional trainings help compounders gain an overview of the FDA’s regulatory framework for compounding, including learning about becoming an outsourcing facility, identifying insanitary conditions in their facilities, and implementing appropriate corrective actions.
To provide interactive educational opportunities, the COE sponsored two in-person trainings before the start of the COVID-19 pandemic and has offered eight live, instructor-led virtual trainings to outsourcing facilities during the pandemic. Currently, the COE hosts six publicly available, free, self-guided online trainings focused on CGMP, cleanroom operation, sterile processing, and much more. Participants can complete these courses at their own pace and receive continuing education credits.
Since the creation of the COE, the feedback has been positive, with outsourcing facility participants indicating the trainings have enabled them to increase their technical knowledge and improve facility operations. To date, more than 820 participants received continuing education credit across all courses and nearly 80% of registered outsourcing facilities completed one or more trainings.
To better understand the challenges and opportunities that outsourcing facilities face, the COE conducted a large research effort from 2020 to 2021 that included data analysis and individual conversations with outsourcing facilities and other stakeholders. The information discovered during this effort has helped the agency gain more knowledge on outsourcing facilities’ business growth and viability and adherence to CGMP regulations. It has also allowed us to obtain feedback on their interactions with the FDA. Overall, the COE’s research effort provided outsourcing facilities with another channel to communicate with the FDA beyond the scope of inspections.
This research has also provided useful insights into the outsourcing facility sector and will further enhance the COE to make it valuable for outsourcing facilities, the FDA, and other stakeholders. Research will continue this year and into future years and will include analyses to track market trends.
The COE inaugural conference in 2020 brought together more than 350 individuals representing current and prospective outsourcing facilities, regulators, health systems, and other stakeholders to discuss topics related to compounded drug quality and best practices. The 2021 virtual conference will feature panels on inspections and regulatory oversight, health care provider perspectives on compounding quality and patient needs, and the future of the outsourcing facility sector. Additional sessions will address CGMP expectations and manufacturing best practices, including an in-depth review of quality management systems, stability evaluation, and establishing robust standard operating procedures. There will also be updates from the FDA about the latest policies applicable to drug compounding, including compounding during the COVID-19 pandemic and the use of bulk drug substances. An optional pre-conference session geared toward first time attendees will be held on September 13. Registration is free and information can be found on the FDA’s website.
We recognize the COE’s value in facilitating collaboration between the agency and outsourcing facilities. We will continue to pursue information sharing as the COE continues to help compounders improve the quality of compounded drugs. The FDA intends to provide new training courses for outsourcing facilities in the future, covering topics such as supplier and contractor qualification and management, process validation, and quality management systems. Protecting patients from poor-quality compounded drugs is a shared responsibility among the FDA, states, compounders, and other stakeholders. When there’s a steadfast commitment to attention to quality, everyone wins.
Your feedback is essential to the success of the COE. Please feel free to email us at: CompoundingQualityCoE@fda.hhs.gov.