AG calls for regulation of drug compounding centers
September 19, 2013 | MPRN At least 264 people were infected by an adulterated pain medication, and 19 died. Michigan suffered more casualties from the outbreak than any other state.
“We owe it to the victims of this tragedy to ensure something of this magnitude does not happen again,” Schuette said at a press conference. “It is my hope that passage of this legislation combined with the outcome in our justice system provides some level of closure to this unfolding healthcare emergency.”
However, these proposed rules would not have prevented last year’s outbreak because the compounding center was in Massachusetts. Schuette says Congress should also enact nationwide standards.
Compounding pharmacies mix customized medicines based on doctors’ prescriptions. They are not regulated by the U.S. Food and Drug Administration. There are 470 compounding pharmacies operating in Michigan.
Schuette endorsed legislation to be introduced in the Michigan Senate to require compounding centers to be inspected every two years, and that the centers have a chief pharmacist on staff to take charge of record-keeping. The legislation would also subject center owners to criminal background checks.
Michigan Department of Licensing and Regulatory Affairs Director Steve Arwood says a “pharmacist-in-charge” could help quickly identify the source and path of an adulterated drug.
“In any regulation, our department must ensure that the highest priority is given to situations where citizens’ health and safety is exposed to high risk,” he said. “Clearly this is one of those situations.
“Our residents have every right to expect that compounded pharmaceuticals made or coming into our state are safe.”
Arwood says the state embarked on inspections in the immediate aftermath of the outbreak.
The clinics that administered the tainted medication are in Brighton, Grand Blanc, Traverse City, and Warren.
A multi-count grand jury is also examining whether the Massachusetts compounding company or the clinics can be charged with criminal wrongdoing in Michigan.
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