The New England Compounding Center is under scrutiny as investigators try to determine how a steroid solution supplied by the pharmacy apparently became contaminated with a fungus.(Photo: Stephan Savoia, AP)
BOSTON -- A state board is
setting new rules for compounding pharmacies in the wake of a deadly
U.S. outbreak of fungal meningitis linked to a specialty pharmacy in
The Massachusetts Board of Pharmacy on Thursday
approved emergency regulations which, among other things, will require
Massachusetts pharmacies to submit reports twice annually to prove they
are not acting as manufacturers.
Pharmacies would be required to
sign, under penalty of perjury, affidavits that they are only mixing and
dispensing prescriptions for individual patients.
officials have previously said New England Compounding Center violated
its license by distributing drugs in batches as a manufacturer would.
new regulations would also require pharmacies to report any
disciplinary actions by any other states or the federal government, and
stiffens penalties for breaking the rules.