A Westborough pharmacy and drug manufacturer with the same owners as the Framingham specialty phamacy at the center of the national fungal meningitis outbreak will remain closed until at least Nov. 19.
The temporary closure of Ameridose LLC, by mutual agreement with state regulators Friday, was extended two weeks to give investigators more time to complete an inspection of the facility, after the company recalled its products this week.
The Massachusetts Hospital Association released a statement saying the continued shutdown of Ameridose, which supplies more than 3,000 hospitals nationwide, “heightens Massachusetts hospitals’ concerns about the possibility of prolonged and serious shortages of important medications.”
Ameridose had been scheduled to reopen Monday, but this past Wednesday it agreed to recall all its products after federal investigators identified shortcomings in its safety testing. The company acted on the recommendation of the US Food and Drug Administration but said it issued the recall voluntarily and had not received any reports of illness.
A letter dated Friday and signed by the president of the Board of Registration in Pharmacy and a lawyer for Ameridose states that the “board finds it necessary to extend the Agreement to conduct a comprehensive investigation of the facility operations.”
Hospital leaders said the extended closure has forced hospital staff to work around the clock making drugs in their own pharmacies because many of the medications in short supply are routinely needed in operating rooms.
The hospital association said that the hospital community continues to work with state health officials “to address the escalating drug shortages, and Massachusetts hospitals are looking to the appropriate state and federal agencies to help identify and secure safe alternative sources for critically needed medications.”
The suspension agreement also applies to Alaunus Pharmaceutical a wholesale distributor in Framingham that shares ownership with Ameridose and New England Compounding Center.
Ameridose and Alaunus agreed to a voluntary shutdown Oct. 10, as public health officials said they wanted to look more deeply into businesses owned by the same families that own New England Compounding.
An injectable steroid pain medication produced at New England Compounding is believed to have now sickened more than 4o0 patients in 19 states. The US Centers for Disease Control and Prevention said Friday that 404 patients have fallen ill, most with fungal meningitis but also some with joint infections. The agency said the death toll had increased by one, to 29.
In New England, 11 cases have been reported in New Hampshire and 2 in Rhode Island.
The contamination problems at New England Compounding have raised questions about the state pharmacy board’s oversight of compounding companies. On Thursday, the Patrick administration unveiled new emergency regulations to more tightly oversee the industry, including rules that will allow the state to track the volume and distribution of drugs made by compounding pharmacies to determine whether they are operating more like a manufacturing facility subject to licensing by the US Food and Drug Administration.
“It is our sincere expectation that these progressive emergency regulations, coupled with more stringent federal oversight, will provide necessary and improved scrutiny over compounding pharmacy practices," board president James DeVita said in a statement Friday.
DeVita also said the board is committed to working in a “transparent manner” and pledged to post copies of board minutes from the past decade on its website this weekend. He also said board minutes will be posted after future meetings.