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'Objectionable Conditions' Persist at Drug Compounding Facilities

Cheryl Clark, for HealthLeaders Media, August 8, 2013

The issues were serious to result in seven of the 31 pharmacies recalling "some or all of their sterile compounded products" produced under these observed conditions. For example:

"FDA sampled a compounded sterile injectable solution during one of its inspections in March 2013 and found bacteria in the product," resulting in a nationwide recall of over 50 sterile drug products.

"Another compounding pharmacy recalled its sterile drug products that had not yet reached the expiration date listed on the product because of a lack of sterility assurance." The products had supplied medical professional offices in that state. "However, some patients that received products from those medical professionals may live in other states."

Joseph Hill, director of federal legislative affairs for the American Society of Health-System Pharmacists, praised the GAO report saying it "provides further credence to the argument that the current regulatory environment around compounding is flawed and the gaps that currently exist enabled NECC to be licensed as a pharmacy while behaving more like a drug manufacturer."

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