Two additional recalled products from the New England Compounding Pharmacy — the facility that produced the steroids responsible for the ongoing fungal meningitis outbreak — have tested positive for bacterial contamination.
FDA and CDC laboratories have identified bacteria in three lots of preservative-free betamethasone and a single lot of cardioplegia solution.
“These results and the finding of fungal contamination of methylprednisoloneacetate reinforce the FDA’s concern about the lack of sterility in products produced at NECC’s compounding facility and serve to underscore that hospitals, clinics and health care providers should not use any NECC-supplied products,” the agency said in a press release.
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In the meantime, nine additional cases have been identified in the fungal meningitis outbreak, including five in Michigan. In positive news, the death toll is not as high as was previously reported. There have been two deaths in Virginia, not three, as was mistakenly reported on Wednesday, the CDC confirms. The total number of fatalities since the outbreak began in late September is 28.
To date the CDC is reporting a total of 386 infections, including 377 cases of meningitis, stroke or other central nervous system infections, as well as nine cases of peripheral joint infections.
Michigan has surpassed Tennessee as the state hardest hit, with 112 cases and seven deaths. Tennessee now has 75 cases and 11 deaths, and Virginia is reporting 46 cases and two deaths.
Massachusetts state legislators are currently considering a bill that would give the FDA clearer authority to regulate compounding pharmacies, which traditionally provide custom drugs for individual patients when health-care providers request medications that are not commercially available.
But NECC was functioning more like a drug manufacturer than a licensed compounding pharmacy, health officials have reported.
“Compounding pharmacies have been governed by fragmented regulations for too long, leading to the worst public health disaster in recent memory,” Congressman Edward Markey (D-Mass.), said in a press release.
The Verifying Authority and Legality In Drug (VALID) Compounding Act, proposed by Congressman Markey, would:
- Allow the FDA to regulate compounding pharmacies that are operating as drug manufacturers in the same way it regulates standard drug makers, including inspecting them.
- Allow some compounding pharmacies, such as hospital pharmacies or small community firms, to request waivers to enable them to compound drugs before they get a valid prescription.
- Allow the FDA to waive the requirement for valid prescriptions for individual patients in the event of a drug shortage or to protect public health.
- Require the FDA to create and maintain a publicly available “Do Not Compound” list of drugs that are not safe or effective when compounded.
- Require compounded drugs to be labeled so consumers know they have not been tested by the FDA for either safety or effectiveness.
