FDA quietly steps in to inspect a second Massachusetts pharmacy after determing it has federal authority

January 9th, 2013 // 3:58 pm @ jmpickett

Federal regulators have quietly stepped in to inspect another Massachusetts pharmacy similar to New England Compounding Center, the Framingham compounding company blamed for the national fungal meningitis outbreak that has sickened more than 660 people and killed 40.
Inspectors from the US Food and Drug Administration recently joined state officials in their ongoing surprise inspections of compounders to inspect one pharmacy because the regulators determined the company’s actions fell under federal jurisdiction, Dr. Madeleine Biondolillo, director of the state’s Bureau of Health Care Safety and Quality, said in an interview Tuesday.
Biondolillo declined to name the pharmacy inspected by the FDA, or discuss the precise reason the FDA stepped in, but said, “The FDA has authority over certain things and if they feel this registrant is performing business practices in their domain, that’s their call.
Investigators have said that New England Compounding violated state laws by mass producing drugs, behaving more like a manufacturer, which would fall under federal jurisdiction.
Biondolillo said the surprise inspections of sterile compounding pharmacies, ordered in October by Governor Deval Patrick, are nearly complete.
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