FDA’s Compounding Quality Center of Excellence is focused on improving the quality of compounded drugs to promote patient safety.
Compounded drugs pose unique risks to patients because they are not reviewed by the agency for safety, effectiveness or quality before they are marketed for patient use. Our top priority is to help ensure that compounded drugs are safe by focusing on quality. Patient safety is the shared responsibility of FDA, state regulators, pharmacy associations and compounders, including outsourcing facilities.
The Center of Excellence engages and collaborates with outsourcing facilities, compounders and other stakeholders to improve the overall quality of compounded drugs. The Center of Excellence promotes collaboration to help compounders implement robust quality management systems that are better for patient safety and business.
The Center of Excellence offers training and development opportunities on manufacturing quality and other policies pertaining to outsourcing facilities, including current good manufacturing practices (CGMPs). CGMPs for outsourcing facilities are particularly important because their compounded drugs reach many patients across the country. These efforts are intended to help bolster the outsourcing facility industry’s ability to provide quality compounded drugs to patients who need them.
The Center of Excellence also will host its second virtual conference in 2021 to bring together current and future outsourcing facilities, regulators and other compounding experts and stakeholders to discuss key topics and best practices. Details to be announced.
Contact CompoundingQualityCoE@fda.hhs.gov with questions.