When federal inspectors toured the Massachusetts compounding pharmacy responsible for the meningitis outbreak sweeping the nation, they discovered “greenish-black” foreign matter in vials that were supposed to be sterile. The defective shots have led to 338 cases of fungal meningitis and 25 deaths from the dangerous condition. The company responsible, New England Compounding Center, has recalled all of the vials and shut down the Framingham, Massachusetts, facility.
A compounding pharmacy is intended to create custom medications based on individual prescriptions. They are often used to provide medications at unusual doses or in unusual delivery systems for patients with allergies or other special needs. Among the accusations leveled at the NECC are that it was mass producing drugs without tailoring them to specific prescriptions.
FDA investigators found the greenish-black substance in 83 of the 331 vials they inspected. They found white filamentous material in an additional 17 vials. FDA analysis showed that 50 out of 50 vials they tested had microbial growth, despite the fact that the sample taken by the NECC gave a sterile result. The outbreak has led many to conclude that greater oversight is necessary in the case of compounding pharmacies.
More than 14,000 people received shots that may have been contaminated with fungus. Such a massive outbreak is bound to draw attention to the laws and testing procedures surrounding such facilities. It is not clear if the NECC is unusual in the industry or if it reflects the state of compounding pharmacies as a whole.
Source: USA Today, “‘Greenish-black’ material tied to meningitis deaths,” by Elizabeth Weise, 26 October 2012