Rep. Lewis Joins Public Health Committee in Approving Compound Pharmacy Oversight Bill

State Representative Jason Lewis, who serves as Vice Chair of the Joint Committee on Public Health, joined his Committee colleagues last week in reporting favorably legislation aimed at strengthening oversight of the state’s compounding pharmacies in order to protect patient safety.

The bill was crafted by the Public Health committee in response to a number of regulatory failures identified by a fungal meningitis outbreak last year that was traced to injectable steroids manufactured by New England Compounding Company, a Framingham compounding pharmacy that was licensed to produce small batches of pharmaceuticals for individual patients, but was making drugs wholesale. The outbreak sickened 749 people and killed 61 in 20 states, according to the Centers for Disease Control.

“This legislation is a vital response to protect the citizens of Massachusetts, as well as patients across the country who rely on drugs manufactured here in Massachusetts,” said Rep. Lewis.  “Unfortunately there is nothing we can do to reverse the tragedy that occurred last year, but at least we can take strong action to try and prevent such a tragedy from ever happening again.”

Among other provisions, the bill reconstitutes the Board of Registration in Pharmacy, creates specialty licenses for in-state and out-of-state sterile compounding pharmacies, mandates unannounced inspections of all sterile compounding facilities, requires reports of the type of drugs pharmacies produce and at what volume, and requires the state to collect and analyze data on adverse events related to pharmaceuticals.   

The bill is expected to be taken up by the full House of Representatives later this year.