FDA: 30 compounding pharmacies have safety hazards

April 12, 2013 at 8:10 AM
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WASHINGTON, April 12 (UPI) -- The Food and Drug Administration announced it found potentially dangerous safety issues at 30 compounding pharmacies across the United States.

After a fungal meningitis outbreak killed 53 people and sickened 680 from the contamination of an injectable steroid at the New England Compounding Center, dozens of "priority inspections" at such pharmacies were conducted between February and April, The Washington Post reported Thursday.

The FDA focused on compounding firms that produce high-risk sterile products. These companies do not have to meet the same safety standards as drug manufacturers.

FDA officials said Congress should give the agency more authority over compounders, the newspaper said.

At one Florida company, FDA inspectors found "black particles of unknown origin" in seven vials of injectable medicine. In other facilities they found rust and mold in clean rooms.

Five pharmacies initially prevented investigators from entering the facilities and making copies of records, the Post reported.

"This shows us that there are facilities out there that are producing products that have significant sterility failures, ones that could represent a serious risk to health," FDA Commissioner Margaret Hamburg said. "Sadly, it also demonstrates, even in light of this tragedy and all of the focus on the issue, that we are still being challenged in our attempt to enter these facilities."

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