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Registering as an outsourcing facility helps rid compounding safety stigma, Fagron

Dan Stanton

By Dan Stanton+

07-May-2015
Last updated on 11-May-2015 at 13:36 GMT2015-05-11T13:36:11Z

Registering as an outsourcing facility helps rid compounders of stigma

Compounding pharmacies must show they can produce high-quality medicines in order to overcome their safety stigma, according to Fagron which is opening a sterile facility in Kansas.

Fagron North America is investing $15m (€13m) into a new 50,000-square-foot facility inWichita,Kansas, close to the manufacturing facility run by JCB Laboratories, a fellow sterile compounding firm acquired by Fagron in December 2013.

The plant - set to open in November - will feature 12,000sq ft of clean room space and is described by the firm as "one of the largest 503B human drug outsourcing facilities in the US."

Compounding Problems

The compounding industry has been under the shadow of the meningitis outbreak - linked to contaminated methylprednisolone made by the New England Compounding Centre (NECC) in Massachusetts- in 2012 which killed over 60 people . A number of other cGMP failings haven't helped alleviate the stigma.

But Brian Williamson, president of JCB Laboratories and Fagron Sterile Services, told this publication the FDA's guidance and actions , following changes in law implemented by the Drug Quality and Security Act (DQSA) of 2013, are helping turning the industry around.

Fagron, therefore, went into the design of the new facility with cGMP in mind, and will use automated pharmaceutical compounding systems which are essential for a sterile manufacturer in registering a site as an outsourcing facility.

"Our operations and business have been able to adapt positively to the changes," he told Outsourcing-Pharma.com. "We have seen an increase in business and we feel that our customers now understand the complexities and costs associated with complying with cGMP guidelines. Overall, this has been a very positive experience for us."

While regulations are of course important, Williamson added: "The best way to overcome stigma is to demonstrate that safe, high-quality medications can be effectively produced by compounding pharmacies and outsourcing facilities, and that is what we do every day."

No organisation currently keeps a tally of compounding pharmacies in theUS, but the number of outsourcing facilities is currently about 50, according to the FDA.

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