A Massachusetts hospital is one of 14 compounding pharmacies nationwide that has voluntarily registered with the Food and Drug Administration as the federal agency pushes states to inform businesses of new regulations passed in the wake of a deadly fungal meningitis outbreak.
Marlboro Hospital, a member of UMass Memorial Health Care alliance, is the only Bay State facility on the FDA's list of 14 compounding pharmacies registered by the federal agency.
Candra Szymanski, the hospital's chief operating officer who oversees its pharmacy, said the small community hospital sought FDA licensing of its pharmacy more than two years ago to increase supervision and boost quality when they began looking to provide compounded drugs to other hospitals in their affiliated group.
"We decided to up the ante a little bit and to be sure of the quality of the drugs we produce at our hospital and for the system if we do so," Szymanski said.
The new registration was a natural continuation of the FDA licensing Marlboro Hospital took on voluntarily, Szymanski said, which led to the hospital's pharmacy mixing drugs, not only for its own patients, but also for those at UMass Memorial Medical Center campuses.
In November, Congress enacted new regulations under which compounding pharmacies can voluntarily register with the FDA and submit to federal inspections in response to last year's fungal meningitis outbreak that was traced to the New England Compounding Center in Framingham that killed 64 people and sickened 751.
U.S. FDA Commissioner Margaret A. Hamburg last week sent letters to state officials who regulate compounding pharmacies on the local level to push the companies to seek federal registration, thereby voluntarily submitting to FDA oversight.
"States have a critical role to play in the oversight of pharmacy compounding," Hamburg wrote in her Jan. 8 letter to state health officials. "One new opportunity afforded states by (the new law) is the ability to encourage compounding pharmacies located outside of the state that ship compounded drugs into the state to register with FDA as outsourcing facilities. Once facilities are registered, states could be assured that FDA will inspect the facilities on a risk-based schedule."
She said there are more than 15,000 compounding pharmacies across the U.S. and federal food and drug officials continue to find problems at some of them.
Massachusetts lawmakers continue to work to come up with state regulations on compounding pharmacies. A conference committee met for the first time last week to sort out differences between House and Senate versions of a bill.
"When Governor Patrick launched his series of aggressive pharmacy reforms last fall, our mission was to ensure every patient can feel confident in knowing that their medicine is safe," state Department of Public Health spokeswoman Anne Roach said in a statement. "We look forward to continuing our work with leaders at the state and federal level to advance additional reforms that continue this mission."
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