Massachusetts officials said Sunday they had closed another pharmacy as part of a crackdown after an outbreak of fungal disease that has killed 25 people and made 344 sick.
They said a surprise inspection turned up unsaniitary conditions at Infusion Resource, a compounding pharmacy in Waltham, Massachusetts that prepares sterile, injectable medications. The facility was also administering injections, something it wasn’t licensed to do, said Dr. Madeleine Biondolillo, director of the state department of health’s Bureau of Healthcare Safety and Quality. Biondolillo did not say any products from the pharmacy were in any way linked to the ongoing outbreak linked to pain injections.
The Centers for Disease Control and Prevention on Saturday reported six new cases of fungal disease in the outbreak traced to steroid injections made by the New England Compounding Center in Massachusetts, bringing the total to 344 cases of infection in 18 states, with 25 deaths. Officials have closed NECC and a separate pharmacy with common ownership, Ameridose, has also closed.
The fungus causes an unusual type of meningitis in some patients who got injections directly into their spines, and patients must undergo weeks or months of treatment with antifungal drugs that themselves can be dangerous, with severe side-effects. State and federal regulators are working to find out how the drugs got contaminated and how the pharmacy managed to operate at such a large scale for so long.
On Friday, the Food and Drug Administration released details of some of its inspections of NECC, and said it found greenish black matter growing in some of the products. The FDA doesn’t regulate compounding pharmacies like it does drug manufacturers, but can look for unclean conditions. The FDA said it found dirt, puddles of water and improper sterilization practices at NECC.
State health agencies are supposed to regulate compounding pharmacies but Massachusetts officials say they didn’t have the power they needed to keep tabs on NECC, which had received several state and federal warnings in recent years. Smith said her department was preparing regulations to require compounding pharmacies to submit frequent reports about sterile, injectable medications -- especially how much they are making and distributing. “This reporting will allow us to better identify large-scale operations acting more as a manufacturer, which requires federal licensure and additional scrutiny,” she said.
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