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Compound interest? US FDA sets up compounding pharmacy advisory committee

Dan Stanton

By Dan Stanton+

Last updated on 17-Dec-2014 at 12:37 GMT2014-12-17T12:37:19Z

Compounding the problem? US FDA sets up committee for compounding pharmacies
Compounding the problem? US FDA sets up committee for compounding pharmacies

The US FDA has set up a committee to provide advice on scientific, technical and medical issues concerning drug compounding.

After the Drug Quality and Security Act (DQSA) became law last November, the US Food and Drug Administration (FDA) issued guidance in which it defined compounding pharmacies as outsourcing facilities in order to ensure such firms comply with current Good Manufacturing Practices (cGMP).

Yesterday the agency announced it had selected a committee of 12 voting and two non-voting members - comprising experts in pharmaceutical compounding and manufacturing, pharmacy, medicine, and pharmaceutical regulation - taken from over 100 nominations.

“This is a key step toward implementing the compounding provisions of the Drug Quality and Security Act,” director of the FDA’s Center for Drug Evaluation and Research Janet Woodcock said, adding compounders and the agency “will benefit greatly from the advice and recommendations the members of the committee provide.”

One area the Committee will advise on is Section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) added earlier this year which lays out specifics on facility design, environmental and personnel monitoring, equipment, production and process controls, release testing, lab controls and other areas of concern.

The need to address compounders on quality issues came to light after an outbreak of fungal meningitis which affected 751 patients and killed 64 in 2012 was traced back to medication packaged and marketed by the New England Compounding Center (NECC), a compounding pharmacy in Framingham, Massachusetts.

Glenn Chin, a supervising pharmacist at the company, was arrested by US authorities in September as part of an ongoing investigation.

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