Crackdown on drug compounders spurring more recalls

October 9, 2014

Following the 2012 fungal meningitis outbreak that killed 64 people and sickened hundreds, FDA tightened regulations on compounders like the New England Compounding Center in Massachusetts to which the tainted drugs were linked.

Following the 2012 fungal meningitis outbreak that killed 64 people and sickened hundreds, FDA tightened regulations on compounders like the New England Compounding Center in Massachusetts to which the tainted drugs were linked.

A result of that crackdown has been an unprecedented number of drug recalls and citations against compounders for bad practices, according to a report by USA Today.

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According to the newspaper’s analysis, compounding pharmacies have issued more than 50 recalls in the past two years, with 20% of those being classified as dangerous or defective products that could cause serious health problems or death.

 

"We are out there doing more inspections … (and) a substantial portion of the recalls are linked to problems we discovered during those inspections," Ilisa Bernstein, deputy director for compliance at the FDA's Center for Drug Evaluation and Research, told the newspaper. “The seriousness of the findings (in) the inspection reports we've issued suggests there also were many problems prior to 2012."

According to the report, FDA performed nearly 150 inspections of compounding pharmacies between October 2012 and September 2014. In 90% of those inspections safety or sanitary issues were found. Those violations ranged from workers wearing dirty gloves to visible mold growth in medications.

 Since October 2012, FDA has issued more than 30 warning letters to compounding pharmacies for “serious” deficiencies, the report said.