Massachusetts Mulls New Rules for Compounding Pharmacies
State health officials want Massachusetts – where a deadly fungal meningitis outbreak originated – to lead the nation with new rules for compounding pharmacies.
On April 2, interim Public Health Commissioner Lauren Smith outlined Gov. Deval Patrick’s proposed legislation that would beef up inspections, require special licenses for sterile compounders, institute a system of fines for violations, and reduced the number of pharmacists serving on the state’s regulatory board.
Smith and others testified for more than three hours before the Legislature’s Joint Committee on Health Care, which held a public hearing on several bills filed in the wake of health and safety problems at the New England Compounding Center in Framingham, Mass. IACP representatives were in attendance at this hearing. The following is a recap of the hearing:
“I am more concerned now than ever,” said Rep. Jeffrey Sanchez, a Democrat and House chairman of the legislative committee.
Pharmacists urged lawmakers not to “water down” the board and instead infuse it with more expertise and resources.
“Decreasing the number of pharmacist members would be a serious mistake. The practice of pharmacy is becoming more complex and diverse,” stated Todd Brown, executive director of the Massachusetts Independent Pharmacists Association. “The Governor’s legislation ignores his own (special) commission, which recommends a minimum of six pharmacists.”
There was strong support for annual inspections of compounding pharmacies. Smith said the fiscal 2014 state budget includes $1 million to “nearly double” the current inspection force of five full-time equivalent positions. She also highlighted a whistleblower provision to encourage pharmacy employees to bring violations to the board.
“We are shifting away from a complaint-driven structure and towards one suited to be preventative instead of reactive,” Smith said.
Timothy Hudd, president of the Massachusetts Pharmacists Association, supported the governor’s plan to license out-of-state pharmacies but said the bill should be expanded to require a “manager of record” listed by name for each licensee; annual inspections; and reporting of any “action” by the FDA or out-of-state regulators to the Massachusetts Board of Pharmacy.
Kevin Outterson, associate professor of health law at Boston University School of Law, called for making the top people at compounding pharmacies “personally liable” – similar to the Sarbanes-Oxley/SEC requirement that CEOs and CFOs sign off on their financial statements so they “can’t hide behind a corporate shield.”
Smith said the “borders” between FDA and state board authority are still being determined, and that a state-only approach will be limited in its effectiveness. “If a compounding pharmacy is creating the equivalent of an FDA-overseen product, then you have a dilemma,” she said.
Several hospital representatives noted drug shortages and greater difficulty in obtaining compounded drugs in the wake of NECC, including Boston Children’s Hospital.
“We are now scrambling to find this,” Patterson said, referring to a recent recall of sterile compounded medications, including those used to treat bladder ailments in children.
Smith noted that non-sterile compounding is a “very important activity that we wouldn’t want to constrain in any way.” IACP is closely following legislation in Massachusetts and will keep our members informed of new developments.