FDA quietly steps in to inspect a second Massachusetts pharmacy

FDA quietly steps in to inspect a second Massachusetts pharmacy

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

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.

She said 38 pharmacies in Massachusetts identified themselves as performing sterile compounding — making products that must be sterile enough to be used as injections or infusions. Officials said earlier they believed there were roughly 25 such companies.

At least four compounding companies have been issued cease and desist orders since the unannounced inspections started, including one that was temporarily closed.

Biondolillo briefed the state pharmacy board about the inspections and the FDA’s involvement in one inspection after the board approved regulations, to go into effect Feb. 1, that tighten oversight of the compounding industry in Massachusetts.

The rules keep the most controversial aspect of temporary emergency regulations, adopted Nov. 1, despite protests from several pharmacy groups. They allow the state to shut down a pharmacy for up to 21 days without a hearing if a problem is found, to “protect the public health, safety or welfare.”

Iyah Romm, policy director of the Bureau of Healthcare Safety and Quality, which oversees the pharmacy board, said bureau staff conducting unannounced inspections of compounders have found they need 21 days to thoroughly investigate a facility.

Closure under a cease and desist order is intended to give the pharmacy and state regulators time to address concerns and help the company reopen, whereas a license suspension is more serious, Romm said.

But some board members said they remained concerned that such a long closure would be interpreted as a disciplinary action, particularly in other states, even though the rules say that the move is not disciplinary in nature.

“It’s incumbent on the board and staff to communicate the distinction,” Romm said. “The intent is to get a pharmacy back up and running” while a summary suspension is “leading down a very different path.”

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