Another Mass. compounder shut down
BOSTON — Massachusetts shut down another compounding pharmacy after a surprise inspection last week found alarming conditions that called into question the sterility of its products, state officials have said.
The pharmacy, Infusion Resource in Waltham, voluntarily surrendered its license over the weekend, said Dr. Madeleine Biondolillo, director of the Bureau of Health Care Safety and Quality at the Massachusetts Public Health Department. Inspectors who visited Infusion Resource on Tuesday found “significant issues with the environment in which medications were being compounded,” Biondolillo said during a news conference here on Sunday.
She would not disclose details, but said that in another troubling discovery, patients had apparently been receiving intravenous medications at the pharmacy, against state regulations.
The findings led the state to immediately issue a cease-and-desist order, Biondolillo said. But she added that as of yet, there was no evidence of any contaminated drugs produced there.
In an e-mailed statement, Bernard Lambrese, the chief executive of Infusion Resource, said, “No issues were cited relating to the integrity of our products nor to the quality of our compounding practices.”
He added that the pharmacy was working to address concerns cited by the inspectors, including the condition of the flooring in the room where the pharmacy mixes drugs, and would then seek to be re-licensed.
The latest shutdown comes amid an ongoing investigation of New England Compounding Pharmacy, the company believed responsible for a national meningitis outbreak in which 25 people have died, at least 344 others have fallen ill and as many as 14,000 people are thought to have been exposed.
State and federal inspections in recent weeks found unsanitary conditions at New England Compounding, from surfaces coated with mold and bacteria to residue on sterilization equipment.
New England Compounding has suspended operations and laid off most of its employees.
Gov. Deval Patrick last week directed the state’s Board of Registration in Pharmacy to immediately start unannounced inspections of compounding pharmacies that prepare sterile, injectable medications.
There are 25 such pharmacies in Massachusetts, and Patrick has acknowledged that the state rules governing them were insufficient.
Although the Food and Drug Administration can inspect compounding pharmacies and issue warnings, the agency says states have ultimate jurisdiction.
At the news conference on Sunday, Dr. Lauren Smith, the interim commissioner of the Massachusetts Department of Public Health, said the state was bringing on five additional inspectors to help with unannounced visits to compounding pharmacies.
The goal is to inspect all of them by Jan. 1, she added.