Massachusetts has initiated a massive crackdown on compounding pharmacies in the wake of the recent nationwide fungal meningitis outbreak, where hundreds of people throughout the United States were sickened and at least 45 were killed due to medications mixed at a pharmacy in that state.
The Massachusetts Department of Public Health has ordered 11 compounding pharmacies to partially or completely shut down and has issued citations to 21 others following a wave of surprise inspections.
The inspections included 40 sterile compounding pharmacies statewide and were unannounced. The state announced the actions in a press release this week.
In addition to the inspections, the state has instituted a number of other compounding pharmacy crackdown measures, including a requirement that all of the state’s compounding pharmacies report volume and distribution to the state.
The inspecitons and new rules come following an outbreak of fungal meningitis infections, which sickened nearly 700 people nationwide late last year. The outbreak was traced back to epidural steroid injections sold by the New England Compounding Center (NECC), which issued an epidural steroid injection recall in early October 2012.
NECC sold an estimated 17,000 of the potentially tainted injections nationwide, which the state says was in violation of its compounding pharmacy license.
Compounding pharmacies are supposed to only create drugs on a per-patient basis for local hospitals when that particular product is not available from a licensed pharmaceutical company. NECC’s injections were not FDA approved or monitored, but were sold on a scale that many say made NECC a “stealth” drug manufacturer who avoided almost all of the FDA’s drug safety laws.
When investigators searched NECC’s Framingham, Massachusetts facility, they found vials of supposedly sterile drugs with visible pieces of fungus floating in them.
Almost all of the 11 compounding pharmacies that were shut down had sterility problems that the state believes could have lead to contaminated drugs. Eight of the 11 have since filed corrective action plans to address the problems found by investigators.
NECC faces a growing number of fungal meningitis lawsuits brought by survivors of the outbreak and the relatives of those who died due to their illnesses. The company also faces state and federal criminal probes into its activities.