This initiative by the US Food and Drug Administration (FDA) looks to provide ‘accessible learning tools’ which will support reliable production of compounded products that meet the regulator’s standards, Janet Woodcock, director of the agency’s Center for Drug Evaluation and Research, explained in a statement.
Moreover, Woodcock stated that the FDA plans to boost its engagement with outsourcing facilities through the operations of the Center.
The agency stated that compounded drugs present a greater risk for patients compared to FDA-approved products, since they are not required to undergo the premarket review for safety, effectiveness and quality.
Establishment of the Center of Excellence follows inspections of outsourcing facilities where production conditions concerned the agency, resulting in recalls of compounded drug products and enforcement action. The need to address this issue was highlighted earlier this year, when Woodcock announced plans for the agency to center the drug compounding regulatory operations in the Office of Compliance.
According to the announcement, the Center will have three main areas of focus:
- In-person and online education and training
- A conference to give outsourcing facilities, stakeholders, and the agency an opportunity to exchange ideas and best practices
- Market research to help inform the agency on key issues faced by outsourcing facilities
In-person training will begin in March of this year, with more courses scheduled throughout 2020. Training topics include sterile compounding, environmental monitoring, investigating quality issues, initiating corrective and preventive actions, and proper cleanroom design and practices.
Participants at the training programs would be registered outsourcing facilities and pharmacies that are considering becoming outsourcing facilities. Registrations for the March courses are already open.
The FDA pointed out that the focus of these programs will be put on key aspects of current good manufacturing practice (cGMP) and FDA policies, aiming to enhance the participants’ understanding of necessary procedures and guidelines.
Online education programs will also run, focusing on cGMP, as well as other facets of drug compounding, and they will be offered for free.
Finally, as part of the Center of Excellence initiative, the FDA will conduct market research in order to “better understand the possible barriers and opportunities outsourcing facilities may encounter.”
This refers to issues such as business growth and viability, adhering to cGMP regulations and interactions with the FDA.