Massachusetts Regulators Discover Widespread Failings at Sterile Manufacturing Sites

Posted 05 February 2013 | By

Crises are rarely ones of regulators' own choosing. So in 2012 when pharmaceutical compounding became the topic de jure after a massive outbreak of fungal meningitis, state and federal regulators seemed blindsided, and were scrambling not only to trace the outbreak to its point of origin, but also to answer a more basic, troubling question: could an outbreak of this scale happen again?

A new report just published by the Boston Globe seems to indicate that not only could it happen again, but Massachusetts and US regulators are probably fortunate that it hasn't.

The Massachusetts Department of Health conducted 40 surprise inspections of compounding facilities operating in the state. Of those 40, 11 were ordered to shut down all or some of their manufacturing capabilities. Another 21 were cited for "minor" violations. Just four of the 40 compounding pharmacies were found to be in full compliance with state and federal compounding law, The Globe noted.

The vast majority of problems were related to sterile injectable drugs. Eight of the 11 pharmacies ordered to be shut down had problems directly related to sterile compounding, while an additional pharmacy had issues related to the "Structure and engineering of the clean room."

Of potential interest to US Food and Drug Administration (FDA) officials is the inclusion of PharMerica, a chain of compounding pharmacies that in November 2012 made clear that it was compounding hydroxyprogesterone caproate (17P), a hormone approved as a rare disease drug by FDA in 2011. Marketed under the trade name Makena by KV Pharmaceuticals, the drug was allowed to be compounded by FDA officials so long as it adhered to quality standards.

In PharMerica's November 2012 statement, it said that it had in place "rigorous quality standards" for the drug's formulation. It is not clear if any 17P was compounded at the company's Brockton, MA-based facility. The company has already submitted a "plan of correction," The Globe said.

Regulatory Focus has reached out to FDA for comment and will update this space if we hear back.

Read The Globe's article here.


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