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A New Breed of Pharmacy Compounding Has Outgrown the Law

FDA must have new authorities to regulate these facilities

Margaret A. Hamburg
Mon, 03/25/2013 - 11:27
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The deadly outbreak, in October 2012, of fungal meningitis associated with a compounded medication was a horrible tragedy. I’ve asked myself many times if and how it could have been prevented. I speak for everyone at the FDA when I say that our hearts go out to the many victims, including those still struggling with this devastating infection, and their loved ones.

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Although our investigation of this deadly outbreak has been a top priority, our responsibility at the FDA is also to help make sure this doesn’t happen again. We are currently deploying resources to work with states to inspect certain state-licensed pharmacies that produce sterile drug products, which we believe may present the highest risk. During the past two months we have inspected more than 30 facilities, and we will continue to work to protect public health.

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Submitted by umberto mario tunesi on Tue, 04/02/2013 - 02:10

Worst Practice Outbreak

One: we all do excessively rely on pharmaceuticals: pharmacies' shoppers weigh far more than supermarkets'. Two: pharmaceuticals' business is continuosly increasing at dramatic rates. I wonder how the human gender has lived for millennia without pills. The Law must not have new authorities: the Law must instead silence the charlatans and shamans who sells the pills, once for all. Because it's us who pay for the pills, and for the Law, too.

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