Friday, September 20, 2013

Michigan Attorney General Bill Schuette announces new push for tighter regulations on compounding pharmacies

LANSING -- State regulators are pushing for tighter controls on pharmacies that produce individualized medications for patients in the wake of an incident with a Massachusetts pharmacy that caused hundreds of meningitis infections.

Attorney General Bill Schuette was joined by Sen. Joe Hune (R-Hamburg) and Steve Arwood, director of the Michigan Department of Licensing and Regulatory Affairs at a news conference Thursday morning to announce new legislation targeted at compounding pharmacies.

The proposal comes in response to a 2012 incident involving the now-defunct New England Compounding Center in Massachusetts, where unsanitary conditions resulted in tainted injectable steroids being distributed to more than 260 patients in Michigan, causing 19 deaths.

Schuette said the legislation, which Hune is sponsoring in the Michigan Senate, will increase oversight over compounding pharmacies, which produce medications for individual patients, often by combining medications or converting pill or tablet medicine to liquid or other preparations.

The proposal would give Licensing and Regulatory Affairs additional inspection authority over compounding pharmacies, require each pharmacy to have an on-site pharmacist in charge of record-keeping and would mandate criminal background checks for those pharmacists.

Arwood said the new regulations would allow the agency to trace disease outbreaks or other incidents back to a particular pharmacy "in real time" to prevent widespread injury.

Compounding pharmacies would be required to undergo a site inspection before each two-year renewal of their licenses, Arwood said.

Hune said he was sponsoring the bill to help protect Michigan residents. "We're here to make certain that this awful situation, this crap, never happens again," Hune said.

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