A new bill aims to fill a regulatory gap blamed for a deadly outbreak of fungal meningitis linked to tainted steroid injections.
The Massachusetts House bill, which was months in the making, would boost the oversight of compounding pharmacies in Massachusetts, like the now shuttered Framingham facility, whose drugs have been linked to 749 infections in 20 states.
Sixty-one people have died in the outbreak, which began in September 2012.
“This legislation will hold pharmacies to high standards in quality control and sterility,” Rep. Jeffrey Sánchez and chairman of the Joint Committee on Public Health said in a statement. “But these are achievable standards, and standards they must meet in order to prevent another tragedy like we witnessed with [the New England Compounding Center] and Ameridose.”
The NECC recalled all of its products and shut down operations Sept. 26, 2012, but as many as 1,400 people had already received injections of the fungus-tainted steroid used to treat back and joint pain.
Ameridose, a sister company of the NECC, also recalled its drugs citing sterility concerns.
Unlike drug manufacturers, which develop and distribute drugs under strict regulations from the U.S. Food and Drug Administration, compounding pharmacies concoct customized medicines for individual patients using FDA-approved ingredients under the more lenient supervision of state boards of pharmacy.
The new bill would establish an 11-person committee of unpaid industry experts — the majority of them pharmacists — to advise the Massachusetts pharmacy board, and require a “specialty license” for compounding pharmacies. It would also mandate surprise inspections of compounding facilities and stricter training standards for state pharmacy inspectors.
Sánchez, who spearheaded the measure, said it “recognizes the unique and necessary place specialty compounding holds in the delivery of modern health care as it strives to fill in the ‘grey area’ surrounding current state and federal oversight of compounding pharmacies.”
The bill would also require pharmacies to report the volume and types of drugs produced – a move aimed at curbing in the mass production of compounded drugs.