Pharmacy at Center of Fungal Meningitis Outbreak Violated its Licence

Boston, MAAs concern grows over the multi-state fungal meningitis outbreak, and with the death toll mounting, it now appears that the compounding pharmacy that produced the steroid injection thought to be the cause of the outbreak is in violation of its state licence requirements.

The New England Compounding Center in Framingham, MA, shipped over 17,000 vials of the steroid which is used to treat patients suffering from chronic back pain. Pain clinics in 23 states received shipments of the drug. At least 50 vials have been found to contain the fungus, investigators said.

According to a report on Medpagetoday, Madeleine Biondolillo, MD, director of Massachusetts’s Bureau of Health Care Safety and Quality, said the New England Compounding Center was supposed to make up drugs on a per patient basis in response to a doctor's prescription. "This organization chose to apparently violate the licensing regulations under which they were allowed to operate," Biondolillo told reporters in a telephone news conference Thursday.

In 2006, the Food and Drug Administration (FDA) reportedly sent a warning letter to the New England Compounding Center, charging the company with acting more like a drug manufacturer than a compounding pharmacy. A spokesperson for the FDA has said that the agency does have legal recourse, should it be necessary. The agency had been watching the pharmacy for some time, Medpagetoday reported.

On Thursday, the first fungal meningitis class action lawsuit was filed, in the state of Minnesota.