Patrick signs compounding pharmacy oversight bill
Gov. Deval Patrick on Thursday signed into law an oversight-focused bill that he said, through licensing and labeling requirements, addresses the “gray area” in the compounding pharmacy industry.
The bill is the direct result of a national outbreak of fungal meningitis that was traced to the New England Compounding Center in Framingham, which is now closed. The contaminated drugs led to the deaths of 64 people and put thousands at risk in 20 states in 2012.
According to the U.S. Food and Drug Administration (FDA), compounding pharmacies mix or alter drugs to create medication for an individual patient.
“Lives were lost, people are still sick,” said Rep. Jeffrey Sanchez, D-Jamaica Plain, one of the negotiators charged with hammering out a compromise.
Todd Brown, executive director of the Massachusetts Independent Pharmacists Association, said compounding practices have changed over the last decade due to advances in science and technology, and state laws have not kept up.
The bill signed by Patrick directs the state Board of Registration in Pharmacy to establish new state licenses for sterile, complex non-sterile, hospital and out-of-state pharmacies, and create new penalties and fines for pharmacies not in compliance with the law. The bill also requires labeling and the reporting of “adverse drug events” to the FDA.
The pharmacy board is also directed to conduct unannounced random and risk-based inspections of retail sterile compounding pharmacies.
“It is a bill that not only reacts to a situation that occurred in Framingham, but is proactive” through regulations, according to Sen. John Keenan, D-Quincy, who was also a negotiator on the compromise bill.
Andrew Stein, a compounding specialist at Bird’s Hill compounding pharmacy in Needham, attended the bill-signing ceremony at the State House and said he supports the legislation, which he called “well thought out and responsible.”
Stein said the law will increase costs for his pharmacy and the industry, but it will also “further safeguard the public we serve.”
The bill comes after state officials made their own moves to increase oversight by replacing members of Board of Registration of Pharmacy, appointing a special commission to review oversight procedures and implementing emergency regulations and increased inspections. A new federal law in 2013 created a system for the FDA to track and regulate compounding entities.
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