By Steven Reinberg and Margaret Steele
HealthDay Reporters
MONDAY, Oct. 29 (HealthDay News) -- Massachusetts officials have closed a second compounding pharmacy after a snap inspection last week revealed conditions that might threaten the sterility of its products.
According to The New York Times, Waltham, Mass.-based Infusion Resource voluntarily surrendered its license over the weekend after inspectors found "significant issues with the environment in which medications were being compounded," Dr. Madeleine Biondolillo, director of the Bureau of Health Care Safety and Quality at the Massachusetts Public Health Department, said at a press briefing.
While she did not release details of what the inspection found, Biondolillo did say that patients had been receiving intravenous medications at the pharmacy, violating state law.
The pharmacy shutdown came after revelations of unsanitary conditions at the Framingham, Mass., facility of New England Compounding Center, the plant at the center of the ongoing meningitis outbreak. On Friday, federal investigators said their tour of the plant found foreign, "greenish-black" material in some vials of the injectable steroid suspected as the cause of the illnesses.
The contaminated product was one of a host of potential violations discovered during a recent inspection of the New England Compounding Center's plant in Framingham, Mass., U.S. Food and Drug Administration officials said during a Friday press briefing.
"The investigators observed approximately 100 vials of the steroid drug, which purports to be a sterile injectable drug, that had a greenish-black foreign material and a white filamentous [containing filaments] material inside," Steven Lynn, director of the U.S. Food and Drug Administration's Office of Manufacturing and Product Quality, said during a news conference Friday afternoon.
As of Saturday, the U.S. Centers for Disease Control and Prevention said that 25 people have now died and 344 people in 18 states have been sickened in the nationwide fungal meningitis outbreak.
Vials from the lot Lynn described were shipped by the company to customers this year, he said. The FDA tested 50 of these vials and all were contaminated with fungus, he added.
The FDA also found the company was not able to keep its "clean room" clean, Lynn said. "A clean room is a space designed to maintain a controlled environment with low levels of airborne particles and surface contamination," he explained.
According to the report, the company failed to keep the air conditioner in the clean room running at night, which is standard practice to maintain the room's humidity and temperature control. In the past, the company itself had found mold and bacteria in the clean room, Lynn said.
"In addition, the investigators observed a dark, hair-like discoloration in a transition room that connects directly to a room used to formulate and fill the injectable products," Lynn said.
Massachusetts officials said Tuesday that they had begun a criminal investigation into New England Compounding Center. They added that the company functioned as a drug manufacturer, producing drugs for broad use, rather than filling individual prescriptions for individual doctors, in violation of its state license, CBS News reported.
According to published reports, state records show that the New England Compounding Center was plagued by problems as far back as 2006. Those records, obtained by the Associated Press under a public documents request, showed there was evidence of inadequate contamination control and no written standard operating procedures for using equipment, among other problems, at the facility.
New England Compounding Center and Infusion Resource are both compounding pharmacies. These pharmacies combine, mix or alter ingredients to create drugs to meet the specific needs of individual patients, according to the FDA. Such customized drugs are frequently required to fill special needs, such as a smaller dose, or the removal of an ingredient that might trigger an allergy in a patient.
Compounding pharmacies aren't subject to the same FDA oversight as regular drug manufacturers are, but some members of Congress now say the meningitis outbreak highlights the need for more regulatory control.
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