October 24, 2012 — Massachusetts Heath Department officials have rescinded the pharmacy license of New England Compounding Center (NECC), a compounding pharmacy linked to an outbreak of fungal meningitis. Officials have also found evidence of “several health and safety deficiencies related to the practice of pharmacy.” As of today, the outbreak has sickened at least 317 people, of whom 24 have died in 17 states.
The Massachusetts Board of Pharmacy began their investigation on September 25, soon after NECC recalled three lots of methylprednisolone acetate, an injectable steroid shot that had been associated with the first cases of fungal meningitis. The Board’s ongoing investigation has revealed ample evidence of unsanitary conditions and improper procedure.
NECC was selling the steroid shots without any preservatives, which makes sterilization extremely important. Fungal spores grow aggressively in methylprednisolone and other injectable medications.
Investigations found evidence that NECC did not sterilize medication in “conformance with accepted standards.” The products were not sterilized for an acceptable length of time, nor did NECC test sterilization equipment (such as autoclaves). The powder hoods were visibly dirty, mats outside the clean room were visibly dirty, and there was a leaking boiler next to a clean room.
Other investigations have found evidence that NECC shipped lots of medications before they received the results of sterility tests. This occurred on at least 13 occasions. In some cases, results of sterility tests were not received until 11 days after the drugs were shipped to customers.
The Massachusetts Pharmacy Board also announced that they will begin conducting surprise inspections of other compounding pharmacies in the state. They will also require annual reports on volume, production, and distribution of medications to get an idea which compounding pharmacies have large-scale operations.
There has been growing criticism about the practices of compounding pharmacies mass-producing medications and then introducing them in interstate commerce. Although compounding pharmacies are supposed to only mix custom medications for specific patients, there is a growing practice of mass-producing medications.