Closure of Ameridose, Westborough drug company, extended 6 weeks in meningitis probe
A Westborough drug company with the same owners as the Framingham specialty pharmacy at the center of the national fungal meningitis outbreak will remain closed until at least February 22, public health regulators said Thursday.
Ameridose LLC, which voluntarily ceased operations Oct. 10, will remain shuttered while a joint investigation by state and federal authorities continues into “unsanitary conditions and questionable sterility practices at the facility,” according to a statement by the Massachusetts Department of Public Health.
Since October, the department has secured a series of voluntary, temporary closure agreements with Ameridose to give state and federal investigators “maximum flexibility to complete their work,” according to the statement.
A November report by federal inspectors detailed 15 problems found at Ameridose, a major hospital drug supplier, ranging from insufficient testing of the sterility and potency of the drugs it made to the presence of vermin in an area where sterile products were packaged and stored.
Ameridose agreed to recall all of its more than 2,000 products Oct. 31, after the US Food and Drug Administration said it had not found “adequate assurance of sterility” during an inspection.
An Ameridose spokesman said in a statement Thursday that the company submitted an initial response Dec. 4 to the Food and Drug Administration regarding the sterility and other problems inspectors found at the facility, and submitted a supplemental response on Dec. 31.
“The company remains committed to working cooperatively with both the Mass Board of Pharmacy and the FDA and, to that end, has agreed to extend its temporary closure agreement with the Mass Board through Feb 22, while it continues its communications with the FDA,” the statement said.
More than 650 people have been sickened, and at least 39 have died, in the fungal meningitis outbreak tied to contaminated steroids made at the New England Compounding Center. That company was closed in October and all of its products recalled.
Hospital leaders have said that the extended closure of Ameridose has exacerbated already existing shortages of a number of medications.
To address that issue, state health regulators adopted emergency regulations late last year that allow hospitals to share compounded drugs they make in their own pharmacies with other hospitals. The state health department said in its statement Thursday that regulators will be scheduling a vote “in the near future to make those regulations permanent.”Kay Lazar can be reached at email@example.com. Follow her on Twitter @GlobeKayLazar.