Practices at pharmacy in meningitis investigation were cited six years ago
The compounding pharmacy that made and distributed the injectable steroid that may be the source of a deadly outbreak of fungal meningitis was investigated by state public health officials in January 2006 for complaints made to the Food and Drug Administration (FDA) involving the same steroid.
Compounding pharmacies use FDA-approved medications from pharmaceuticals manufacturers to remix and customize prescriptions for patients, doctors and health care facilities. These pharmacies are not regulated by the FDA. Oversight is left to state agencies.
However, in 2006 the FDA issued a warning letter to Massachusetts-based New England Compounding Center (NECC) highlighting several alleged violations. The letter did not address compounding problems specific to the current meningitis outbreak, but it did inform NECC that “the moment a sterile container is opened and manipulated, a quality standard (sterility) is destroyed and previous studies supporting the standard are compromised and are no longer valid.”
NECC agreed at the time to a full inspection of its compounding practices by a third party. The agreement involved sterility, environmental monitoring, cleaning and sanitizing, and quality assurance programs.
Five months later, the state’s Board of Registration in Pharmacy sent NECC a letter confirming that the pharmacy had satisfactorily completed the terms and conditions in the agreement. NECC was still required to update its standard operating procedures every two years. The company was also put on probation for one year but that order was stayed as part of the agreement and no other fines or punitive actions were required.
NECC is currently being investigated for compounding vials of methylprednisolone acetate, a steroid commonly used to treat back pain, that may have been contaminated with a fungus that has caused five deaths and more than 40 cases of illnesses in seven states due to aspergillus meningitis. Fungal meningitis is not contagious but is extremely rare and difficult to treat.
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