The State of Massachusetts closed another compounding pharmacy over the
weekend after finding unspecified problems at the facility in the Boston
suburb of Waltham that is part of Infusion Resource, a Rhode Island-based
Madeleine Biondolillo of the state Department of Public Health said in a statement that inspectors found problems during an unannounced visit. She said the facility passed inspection in 2009, but not last week.
"Upon arrival," she said in a statement, "inspectors noted significant issues with the environment in which medications were being compounded, which has called into question the company's compliance with nationally accepted pharmacy standards and Massachusetts regulations."
The Associated Press reported that Infusion agreed to contact its 40 patients and their doctors and ask them to return any unused medication. Biondolillo said there was no indication any medication the company compounded was unsafe.
She said the company also had an area to administer intravenous drugs, which it was not licensed to do. She said the company voluntarily surrendered its pharmacy license this weekend.
Biondolillo was not specific, but the problem increased concern about large compounding pharmacies.
The New England Compounding Center is at the center of a national fungal meningitis outbreak. The U.S. Centers for Disease Control and Prevention said in its last update that there had been 355 cases in 18 states and 25 deaths.
Originally, compounding pharmacies were facilities where a pharmacist mixed a special combination of medicine to match a prescription. Using a gray area in the regulatory landscape, manufacturing-size operations have produced medicine in bulk, often without prescriptions.
The FDA released inspection reports that its investigators filed after looking at the NECC facility. The investigators said they saw multiple colors of goo and mold.
The FDA investigators found reports by NECC personnel regarding problems of mold, but not enough seems to have been done to fix them.
The first page of the report noted "greenish black foreign matter" in vials of methylprednisolone acetate, the injectable steroid that has been the biggest source of problems. Patients received the medication to treat pain. There was "white, filamentous" material in other vials of that medicine, and "greenish-yellow" discolorations in one of the machines that is supposed to help sterilize the medicine, according to the report.
The FDA investigators also tried to connect dots or at least point out possible sources of trouble at NECC.
"The firm is abutted to the rear and along the left parking area by a recycling facility that handles such materials as mattresses and plastics," the report said. On Oct. 2, "the area was observed to include large equipment (e.g. excavators and freight trucks) producing airborne particulates (e.g. dust). Rooftop units serving the [heating, ventilation, air-conditioning] system were estimated to be located approximately 100 feet from the recycling facility."
Two days later, "we observed what appeared to be dark particulate and white, filamentous covering the louvers of an HVAC return located behind the autoclave, located in the firm's Middle Room (ISO 7). This autoclave is used for the steam sterilization of formulated bulk drug suspensions, including preservative-free formulations of methylprednisolone and triamincinolone, which are intended for injection."
The investigation is continuing.
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