Traverse City Record-Eagle

Michigan

September 20, 2013

Tighter pharmacy rules planned after deaths

LANSING (AP) — New legislation announced Thursday would more closely regulate 470 compounding pharmacies in Michigan a year after the state became the epicenter of a deadly meningitis outbreak linked to contaminated steroids.

Though the deaths were blamed on a Massachusetts company outside the reach of Michigan regulations, state authorities said a review indicated more should be done to strengthen oversight of state compounding pharmacies.

“We owe it to the victims of this tragedy to ensure something of this magnitude does not happen again,” Attorney General Bill Schuette said in a news conference at his Lansing office, where he was joined by Department of Licensing and Regulatory Affairs Director Steve Arwood and Sen. Joe Hune, who will sponsor the measure.

The bill to be introduced would require compounding pharmacies and manufacturers to undergo an inspection at least once during each two-year licensing cycle.

They are not routinely inspected now.

Compounding pharmacies would have to keep detailed records of their products, and all pharmacies would be required to designate a licensed “pharmacist-in-charge” on site who is responsible for following state laws and rules. Pharmacy owners would need criminal background checks.

“If there is an issue, a known risk out there, this gives us the ability to immediately respond to that, get the detailed information and track it back very quickly,” Arwood said.

Compounding pharmacies mix customized injections, creams and other medications in formulas specified by doctors. They have long operated in a legal gray area between state and federal regulations.

The industry came under scrutiny after a 2012 fungal meningitis outbreak traced to tainted steroids produced at the now-shuttered New England Compounding Pharmacy in Framingham, Mass., killed 64 people and sickened nearly 700 others. The steroids were shipped to four Michigan clinics. Patients who became ill had received injections for neck or back pain.

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