Friday, September 20, 2013

Compounding pharmacy regulations proposed

Michigan compounding pharmacies would face stricter state oversight and new licensing and recordkeeping requirements under legislation announced Thursday in Lansing.

The legislation follows a fungal meningitis outbreak a year ago this month linked to tainted steroids produced at a Massachusetts compounding pharmacy and distributed across the country, resulting in 19 Michigan deaths to date.

The legislation, which will be introduced by state Sen. Joe Hune, R-Hamburg Township, would require every compounding pharmacy in Michigan to have a “pharmacist in charge” who would be responsible for all activity at the location.

Compounding pharmacists would be required to maintain records detailing all compounding drugs, including the product’s name, strength, formula to compound, date of preparation, identifying prescription number, name of the person who prepared the compound and the name of the pharmacist who approved the compound.

Background checks would be required for unlicensed compounding pharmacy owners and those licensed before Oct. 1, 2008, under the proposal.

All those engaged in compounding medications would be required to submit to state inspections at least once during every two-year licensing cycle.

The tainted steroids that led to the meningitis outbreak have been linked to New England Compounding Center, also referred to as NECC. The outbreak as of Monday had resulted in eight Livingston County deaths.

Hune on Thursday stood alongside state Attorney General Bill Schuette and Steve Arwood, director of the state Department of Licensing and Regulatory Affairs, in announcing the proposal.
“The NECC was reckless in their actions, and I find that pursuing legislation to strengthen oversight over compounding pharmacies is the least we can do to provide safeguards (to keep) this foolishness from happening in our state again,” Hune said in a statement.

“It is a necessary and imperative action to assure the safety of the citizens of the great state of Michigan. Our citizens cannot afford to fall victim to such ridiculous imprudence,” he added.
Livingston County Circuit Judge David Reader is overseeing a 13-member grand jury that will determine whether NECC broke Michigan law by distributing the tainted steroids. The grand jury, which includes four county members, was empaneled in April for a six-month term, which may be extended if needed.

Congress, meanwhile, is debating whether to give the U.S. Food and Drug Administration more oversight of compounding pharmacies.

Three additional deaths of Michigan residents who received treatment at an Indiana clinic are listed in Indiana patient counts because of where they received the tainted treatments.

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