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Closure of Ameridose, sister company of pharmacy in meningitis outbreak, extended 2 weeks

A Westborough pharmacy and drug manufacturer with the same owners as the Framingham specialty pharmacy 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, was extended two weeks Friday to give investigators more time to complete an inspec­tion of the facility, after the company recalled its products this week.

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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 it agreed Wednesday to recall all its products after federal investigators identified shortcomings in its safety testing. The company acted on the recommendation of the Food and Drug Administration but said it issued the recall voluntarily and had not received any ­reports of illness.

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 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 now believed to have sickened more than 400 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 oversight of compounding companies by the state Board of Registration in Pharmacy.

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 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.

Kay Lazar can be reached at klazar@globe.com. Follow her on Twitter @GlobeKayLazar.
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