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Compounding Updates in MinnesotaDefinitions-Compounding vs Manufacturing: Compounding is differentiated from manufacturing by the existence of a “practitioner-patient-compounder relationship”, per USP 795 and 797, which MN Rules 6800.3300 requires be followed in Minnesota. When a drug product is prepared for office or clinic-use and a specific patient is not named, no such relationship exists – since the pharmacist has no idea who the drug will be administered to at the time he or she is preparing it. This, therefore, is not compounding- it is manufacturing, and the sale would be a wholesale transaction. Pharmacies in Minnesota must be licensed by the Board and registered with the FDA as a wholesaler and a manufacturer, and are then subject to good manufacturing procedures. Also, following the ‘1 drug from 1 physician for 1 patient’ rule, if a physician writes out an order on a prescription pad (or as part of an electronic prescription or chart order) that is “for office use”, the order is not a legally valid prescription. A pharmacy is allowed to sell prescription drugs to a physician or clinic IF licensed as a wholesaler. Why this is important: Most of us are probably familiar with the October 2012 outbreak of fungal meningitis traced to epidural methylprednisolone acetate injections. As of January, there were 678 reported cases of fungal infection across 19 states, 375 of which included meningitis, and 44 patients have died. These have all been traced and confirmed to be products packaged and marketed by the New England Compounding Center (NECC). We had 12 cases in Minnesota with 1 death. As a result, there are both state and national discussions taking place to tighten compounding safety practices, including Minnesota.New England Compounding Center: It is important to note that the NECC was not compounding, they were manufacturing and wholesaling.Changes the Board of Pharmacy is considering:Board of Pharmacy to vet third-party entities that provide certifications and other verification services for pharmacies engaging in sterile compounding.Additional requirements for nonresident compounding pharmacies, including requiring that copies of recent inspection reports be submitted.Current Language:Compounding: Only allowed pursuant to a prescription for an individual patient, while compounding for wholesale distribution or office use is prohibited. A pharmacy may compound a limited amount of medication in anticipation of its own prescription needs, but must receive a prescription for a specific patient before dispensing the medication. All pharmacies located within Minnesota are inspected prior to being granted a new license. In addition to conducting opening inspections, the Board regularly inspects all pharmacies located within the state. Minnesota’s surveyors, most of whom are already knowledgeable in United States Pharmacopeia Chapter 797 standards, will be receiving additional training in this area.?Manufacturing: Entities producing drug products for wholesale distribution within the state must be licensed by the Board as a manufacturer and must also?register?with Food and Drug Administration (FDA) as manufacturers, or submit to the Board a letter from FDA indicating why the entity does not need to register as a manufacturer. A nonresident entity seeking licensure for wholesale distribution of compounded drug products into Minnesota must also submit proof of appropriate licensure in its resident state, or documentation indicating why they are not required to be licensed.? ................
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