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Ameridose must remain shut down

Ameridose LLC, the sister company of the Framingham specialty pharmacy that is at the root of a national meningitis outbreak, will now be shut down until at least the end of the year, under an agreement reached Friday with state regulators.

The company is a major supplier for hospitals across the country. To aid hospitals grappling with drug shortages in Massachusetts, state regulators will propose emergency regulations next week that would allow hospital pharmacies to safely share compounded drugs with other hospitals in need.

In the aftermath of the public health crisis caused by contaminated pain drugs made by New England Compounding Center, Westborough-based Ameridose agreed with state regulators to initially suspend operations on Oct. 10. There have been no infections linked to Ameridose's drugs, but the closure has now been extended three times.


The company had been rescheduled to open this Monday, but it recalled all its more than 2,000 drugs at the end of October after US Food and Drug Administration inspectors found problems with cleanliness and procedures to ensure the sterility of drugs. On Monday, the FDA released a report detailing problems at Ameridose that ranged from the presence of insects and a bird in an area where sterile drugs were packaged and stored, to issues with testing intended to ensure that drugs are sterile and potent.

"Ameridose will remain closed while the joint investigation by state and federal authorities continues into unsanitary conditions and questionable sterility practices at the facility," Alec Loftus, a spokesman for the administration of Governor Deval Patrick, said in a statement. "The FDA's preliminary findings on Ameridose are deeply troubling."

Numerous hospitals depended on Ameridose for critical medications, and Loftus said that next week, the Public Health Council will consider proposed regulations that are intended to help hospitals dealing with drug shortages that have been exacerbated by Ameridose's extended closure. The state is also creating a team of clinical specialists to provide advice to the state on shortages and drug supply.


The company was a major supplier of injectable medications, and during congressional testimony this week, the FDA commissioner said six of its products were already on the agency's shortage list before the company stopped production.

The closure agreement includes Alaunus Pharmaceutical, a wholesale distributor in Framingham with the same owners as Ameridose and New England Compounding, which has closed. Next month, state regulators will review whether Ameridose and Alaunus can reopen in January.

An Ameridose spokesman declined to comment, saying the agreement speaks for itself.

Carolyn Y. Johnson can be reached at cjohnson@globe.com. Follow her on Twitter @carolynyjohnson.