The FDA has formed the Compounding Quality Center of Excellence program to mitigate quality issues with compounded drugs, it announced this week.
Compounded drugs present a greater risk to patients because they aren't required to undergo the agency's premarket survey for safety, effectiveness and quality, the agency stated in its Dec. 19 announcement.
Those risks have become more evident in recent inspections of outsourcing facilities, where some production practices have led to recalls of compounded drug products and enforcement action against some companies, the agency wrote.
The Compounding Quality Center of Excellence is designed to enhance collaboration among outsourcing facilities and provide educational programs for them in order to improve the overall quality of compounded drugs.
The agency said the program, supported by a contract awarded to Deloitte, has 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 inform the agency on key issues faced by outsourcing facilities.
Participation in the program is voluntary, and in-person trainings will target registered outsourcing facilities and pharmacies considering becoming outsourcing facilities. The training sessions will have free registration in order to encourage participation.
The FDA will host a Center of Excellence conference in September 2020 in Dallas as a chance to give outsourcing facilities and related stakeholders a chance to offer feedback on policies and regulatory issues.
With market research, the agency can better understand the possible barriers and opportunities outsourcing facilities may encounter in such areas as business growth and viability, adhering to regulations and interactions with the FDA.
Read the full news release here.
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