Mass. lawmakers OK compounding pharmacy crackdown
Oct. 02, 2013
BOSTON (AP) — The Massachusetts House on Wednesday unanimously approved tougher state regulations on drug compounding pharmacies like the one blamed for a deadly nationwide meningitis outbreak.
The bill, which now goes to the Senate, would require special licenses for compounding pharmacies and require by law that they be subject to unannounced inspections — something that state public health officials had already begun after the aftermath of the outbreak linked to the now-shuttered New England Compounding Center in Framingham.
According to the most recent figures from the federal Centers for Disease Control and Prevention, 64 people had died and 750 others had been sickened in 20 states by a tainted steroid distributed by NECC.
"It's an absolute tragedy that this happened. It was an absolute failure of government," said state Rep. David Linsky, D-Natick, one of several lawmakers who took to the House floor to urge passage of the bill.
Linsky said the combined lack of state and federal oversight of compounding pharmacies led directly to the outbreak.
The pharmacies mix customized injections, creams and other medications in formulas specified by doctors.
Rep. Jeffrey Sanchez, a Boston Democrat who co-chairs the Legislature's public health committee, noted that the U.S. Food and Drug Administration does not regulate compounded drugs in the same manner as it does other pharmaceuticals, leaving oversight of compounding pharmacies to state boards with operating with less resources than the federal agency.
The U.S. House of Representatives advanced a bill last week that would provide the FDA with greater authority to monitor large volume drug compounders.
Critics said these companies, including NECC, had been acting more as drug manufacturers in recent years, producing medications in bulk and shipping them across state lines, rather than acting as specialty pharmacies.
The measure approved by state lawmakers on a 155-0 vote incorporates several of the recommendations made by Gov. Deval Patrick in the aftermath of the meningitis outbreak, including a requirement that compounders report their drug production by type and volume.
Patrick said Wednesday he hoped the recent legislative and congressional actions would clear up "the gray areas between where the FDA's authority left off and ours picked up."
Other highlights of the bill include a requirement that the state track all sterile compounded drugs made by state-licensed pharmacies; whistleblower protection for pharmacy workers; clear labeling of compounded drugs; a requirement that compounding pharmacies report "adverse events," such as illnesses or unintended drug reactions; enhanced training for state pharmacy inspectors and changes in the makeup of the state pharmacy board to reflect a more diverse mix of professional backgrounds.
Two organizations, the Massachusetts Pharmacists Association and the Massachusetts Independent Pharmacists Association, praised the legislation, saying in a joint statement that it would help restore public confidence in compounded drugs and validate to health insurers the importance of covering the costs of the medications.