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503B Outsourcing Facility

Minnesota regulations currently require that 503B Outsourcing Facilities be licensed as both a drug manufacturer and a drug wholesaler.  In addition, if your 503B Outsourcing Facility will be filling patient specific prescriptions, you will also need to be licensed as a non-resident pharmacy.  Please click on the links below for relevant laws, rules and application for each type of license.

Drug Manufacturer

Drug Wholesaler

Pharmacy

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