Updated: 10/10/2012 7:10 PM KSTP.com By: Leslie Dyste
The Massachusetts specialty pharmacy that mixed and supplied a steroid blamed for a deadly meningitis outbreak isn't licensed to distribute the drug in Minnesota, a state official said Wednesday.
Minnesota Pharmacy Board director Cody Wiberg said the New England Compounding Center should have been licensed as a wholesaler and manufacturer in order to sell the drug in bulk to clinics. He said the company has a Minnesota pharmacy license that allows only for the filling of individual prescriptions - not bulk distribution of mixed drugs.
"It's not acceptable to compound large batches and start selling it at wholesale" without obtaining the proper licenses, Wiberg said.
Wiberg wouldn't comment on whether the board is investigating the pharmacy. The company's license status was first reported by the Star Tribune.
The fungal meningitis outbreak has sickened more than 100 people and killed 12. In Minnesota, three women have become ill after steroid shots for back pain.
Minnesota law bans out-of-state drug wholesalers from selling or distributing drugs without a valid state license.
Wiberg said the state also would require a manufacturing license for bulk drug compounding, or custom mixing. Licensed pharmacies are allowed to mix drugs on their premises to fill individual prescriptions, but not to distribute or sell to clinics or other pharmacies. A state manufacturing license also would require a pharmacy to register with the U.S. Food and Drug Administration.
Wiberg said an out-of-state pharmacy would stay within state law if it mixed and shipped drugs only to fill individual prescriptions.
Marsha Thiel, CEO of the Minnesota clinics that administered the steroid, said last week that the clinics received two batches of the drug from the New England Compounding Center. The clinics in the Minneapolis-St. Paul area are Medical Advanced Pain Specialists and the Minnesota Surgery Center.
The Minnesota Pharmacy Board can investigate and take disciplinary action against those it licenses, including suspending or revoking licenses and imposing civil penalties of as much as $10,000 per violation. Wiberg said each shipment of an unlicensed compounded drug could be considered a separate violation. He added that medical professionals licensed by other state boards also could face disciplinary action if they violated state law.
Violations of pharmacy laws also are considered criminal misdemeanors, which state law punishes with jail time of up to 90 days, fines of up to $1,000, or both.
State Health Department spokesman Buddy Ferguson said officials have contacted about 830 Minnesota patients who got the steroid at the clinics, and spoken with all but about 30. He said several hundred were referred to their doctors for evaluations, including those with mild symptoms.
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