FDA’s Compounding Quality Center of Excellence is focused on improving the quality of compounded drugs, primarily those made at outsourcing facilities.
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. Through the Center of Excellence FDA will explore new ways to engage and collaborate with outsourcing facilities, including trainings on current good manufacturing practice (CGMP) requirements, to improve the overall quality of compounded drugs.
CGMP requirements for outsourcing facilities are particularly important because their compounded drugs reach many patients across the country. These trainings aim to enhance understanding of and adherence to quality standards to improve the overall quality of compounded drugs for patients who need them. These efforts are intended to help bolster the outsourcing facility industry.
The Center of Excellence also will foster information sharing between FDA and outsourcing facilities and other stakeholders to enhance FDA’s policy development.
Contact CompoundingQualityCoE@fda.hhs.gov with questions.
- Virtual, interactive trainings are tailored for outsourcing facility staff on several current good manufacturing practice (CGMP) topics, including environmental monitoring, sterile drug compounding and cleanroom conditions. These courses are offered on a first come, first served basis, and continuing education credits are available. The training will open for state regulators and pharmacy compounders if space is available.
- Self-guided online trainings are for outsourcing facility staff, compounders that want to register as outsourcing facilities and other stakeholders on topics related to current good manufacturing practice (CGMP) requirements and policies. These courses also offer continuing education credits.
- Compounding Quality Center of Excellence Virtual Conference: Working Together for Patient Safety
The Compounding Quality Center of Excellence is hosting a conference online, September 21 and 22, 2020, to bring together current and future outsourcing facilities, regulators and other compounding experts and stakeholders to discuss key topics and best practices.