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 in-person and online 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.
- In-person trainings are tailored for outsourcing facility staff on several CGMP-related topics, including environmental monitoring, sterile drug compounding and cleanroom conditions. These courses will begin in March 2020 for outsourcing facility staff on a first come, first served basis, and offer continuing education credits. The training will open for state regulators and pharmacy compounders if space is available.
- 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 in 2020. These courses also offer continuing education credits.
Compounding Quality Center of Excellence Conference: Working Together for Patient Safety
The Compounding Quality Center of Excellence is hosting a conference from September 21-22, 2020 in Dallas to bring together current and future outsourcing facilities, regulators, and other compounding experts and stakeholders to discuss key topics and best practices. We are in the process of developing the conference agenda and would like your ideas and input. Please propose conference topics.