In 2012, patients developed fungal meningitis after receiving injections into the spinal column of a product prepared by the New England Compounding Center (NECC), according to the Centers for Disease Control and Prevention (CDC) and FDA.
A number of things went wrong with these preparations. Because the compounded preparation was a suspension (with visible particles) rather than a solution (a dispersion of the drug at the molecule level), the liquid could not be filtered in a way that would have removed bacteria and fungi. Because the preparation was being injected directly into the spine, no preservative or other additives that might have prevented fungal growth could be added. The drug itself was a type of steroid, and these agents decrease the body’s response to microorganisms, and this might have prevented some patients from fighting off the fungi on their own. Finally, because NECC was distributing the preparation to many states in large quantities—something that compounding pharmacies are not permitted to do under state and federal laws—some of these preparations remained unused for a long time in some cases (allowing the fungi to grow), and a large number of patients were affected.
Inspections of NECC by FDA and the Massachusetts State Department of Health found unsanitary conditions at NECC facilities and violations of the USP<797> standard as well as local law.
The report also found that NECC was distributing large quantities of compounded preparations “apparently for general use rather than requiring a prescription for an individual patient.” State law requires a prescription for compounding and dispensing medication.
“Manufacturing and distributing sterile products in bulk was not allowed under the terms of its state pharmacy license,” the report said. “If NECC was appropriately licensed as a manufacturer with the FDA, the company would have been subject to additional levels of scrutiny.”