October 24, 2012 — Several weeks after New England Compounding Center (NECC) announced that they would be voluntarily rescinding their pharmacy license, the Massachusetts Health Department has announced that they have withdrawn NECC’s license and the licenses of three top pharmacists at the company. Investigations from state health officials have found “several health and safety deficiencies related to the practice of pharmacy.” The contaminated medicines have been implicated in an outbreak of fungal meningitis that has been linked to 317 illnesses and 24 deaths in 17 states.
Compounding pharmacies operate in a nebulous gray area of regulation between the U.S. Food and Drug Administration (FDA) and each state pharmacy board in which they operate. Soon after NECC recalled three lots of methylprednisolone acetate in September, the Massachusetts Pharmacy Board and the FDA began an investigation.
Investigators have found fungal contamination in dozens of sealed vials of medication from the company. Many medicines sold by NECC do not contain preservatives, which makes sterility and stringent testing extremely important — especially for epidural injections, which go directly into a patient’s central nervous system.
According to investigators, NECC did not sterilize their medications in “conformance with accepted standards.” Noted deficiencies included not sterilizing for enough time, failing to test sterilization equipment such as autoclaves, not cleaning visibly dirty powder hoods and mats outside the clean rooms, and not fixing a broken boiler outside the clean room.
The investigators also found at least 13 occasions when the NECC sent medicines to their customers before they received the results of sterility tests. In one case, the results of the sterility test were not sent to the customer until 11 days after NECC sent the medication to the customer.
The Massachusetts Pharmacy Board has outlined several steps they intend to take in the wake of the outbreak. Other compounding pharmacies in Massachusetts can expect surprise inspections in the future. The Board will also require compounding pharmacies to submit annual reports regarding the production, distribution, and volume of medications they are selling. This will help the Board determine whether a compounding pharmacy is mass-producing medications instead of creating custom medications for specific patients.
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