FDA sets up centre to improve quality of compounded drugs

Generics and biosimilars Initiative

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FDA sets up centre to improve quality of compounded drugs

Genéricos/General | Posted 24/01/2020 0 Post your comment

The US Food and Drug Administration (FDA) has established a Center of Excellence to improve the quality of compounded drugs, which are created by combining two or more drugs and are not FDA-approved.

Compounding is the creation of a drug to meet the needs of a patient by combining of processing ingredients. Compounded drugs can, for example, be made from mixing two or more drugs and are used by patients whose needs cannot be met by FDA-approved drug.

Compounded drugs can be essential for patients with unique medical needs but, because they are not approved by FDA, are associated with efficacy and safety concerns.

In a statement last year [1], the Administration outlined plans to work with industry to reduce the risks associated with these products. In a recent follow-up, FDA has announced the establishment of a new Center of Excellence to improve the quality of compounded drugs.

Compounded drugs are often produced by outsourcing facilities, the number of which has increased since the passage of the Drug Quality and Security Act in 2013. Inspections of some outsourcing facilities have revealed concerning practices, in some cases even leading to product recalls and enforcement action.

The FDA’s new ‘Compounding Quality Center of Excellence’ will provide educational programmes for outsourcing facilities to help improve the quality of the products they produce.

Director of FDA’s Center for Drug Evaluation and Research Dr Janet Woodcock commented on the voluntary programme: ‘By providing comprehensive, accessible learning tools, we will support outsourcing facilities in reliably producing high-quality compounded products that meet FDA’s standards […] This initiative will provide an increased awareness and understanding of common issues and provide innovative ways to address challenges outsourcing facilities may face’.

The Center will be managed by Deloitte and will offer in-person and online training; a conference to allow exchange between outsourcing facilities, stakeholders and FDA; and market research to identify the key issues faced by facilities.

In-person training will begin in March and will focus on current good manufacturing practice (cGMP) and FDA policies. Specific topics for the training will include sterile compounding, environmental monitoring and proper cleanroom design.

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Reference
1. GaBI Online - Generics and Biosimilars Initiative. FDA pledges to improve quality of compounded drugs [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 January 24]. Available from: www.gabionline.net/Guidelines/FDA-pledges-to-improve-quality-of-compounded-drugs

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Source: US FDA