* Regulators continue to examine company's facilities
* Massachusetts announces stricter regulations
* FDA tries to plug supply gaps left by Ameridose shutdown
(Adds statement from Massachusetts regulators)
By Toni Clarke
BOSTON, Nov 2 Ameridose LLC, sister company to
the pharmacy at the heart of a meningitis outbreak in the United
States, agreed on Friday to extend its closure by two weeks
while state and federal investigators continue to examine its
The company will remain closed until Nov. 19, according to
an agreement between Ameridose and Massachusetts regulators, a
copy of which was obtained by Reuters.
Ameridose has the same owners as the New England Compounding
Center (NECC), which distributed a tainted steroid used for back
pain that has killed 28 people in the meningitis outbreak. On
Thursday, the U.S. Centers for Disease Control and Prevention
said the toll was revised down from 29 deaths.
Separately, Massachusetts regulators said they had approved
emergency regulations to strengthen the oversight of so-called
compounding pharmacies such as NECC.
Two days ago, Ameridose issued a voluntary recall of all its
products following a U.S. Food and Drug Administration directive
to improve its sterility testing process.
Westborough, Massachusetts-based Ameridose closed on Oct.
10. It said on Wednesday that it had not received any reports of
adverse reactions to the drugs it is recalling. NECC's
injectable steroids turned out to be contaminated with fungus
and as of Thursday, were blamed for 377 cases of fungal
The FDA has said it is in contact with other manufacturers
about filling the supply gap left by the shutdown of Ameridose,
which makes and ships sterile injectable drugs.
In a blog post on Friday, FDA Commissioner Dr. Margaret
Hamburg said the agency has identified a number of Ameridose
products, including drugs used during surgery and to treat
conditions that include congestive heart failure, that were on
the current drug shortages list before the recall.
"We also know that the supply of other drugs may be affected
by the Ameridose recall," she said. "FDA is doing everything we
can to minimize the impact this recall may have on current drug
shortages, and to prevent other shortages from occurring."
James DeVita, president of the Massachusetts Board of
Registration in Pharmacy, said that new regulations adopted by
the body would help "fill the grey area" between state and
federal oversight for compounding pharmacies.
The changes include giving the state board, for the first
time, the ability to track the volume and distribution of
"This action will assist the Board in determining whether
compounding pharmacies are operating in a traditional and
necessary role rather than in a manner analogous to that of a
manufacturing facility," DeVita said.
(Additional reporting by Ros Krasny; Editing by Gerald E.
McCormick, Grant McCool, Steve Orlofsky and Lisa Shumaker)