Minnesota Board Implements Plan to Strengthen Regulation of Compounding Pharmacies

Topics: Compounding

The Minnesota Board of Pharmacy, which already has strong compounding regulations and requirements in place, is in the process of considering additional requirements, some of which will require the passage of new legislation. If the Minnesota Legislature approves an increased appropriation, the Board plans to hire additional surveyors. The Board will also begin vetting third-party entities that provide certifications and other verification services for pharmacies engaging in sterile compounding. To further protect the public, the Board is considering additional requirements for nonresident compounding pharmacies, including requiring that copies of recent inspection reports be submitted as a requisite for licensure, and requiring documentation of how past violations were resolved. Facilities located in states in which regular inspections are not performed may be required to submit to an inspection by a Board-approved entity that is qualified to perform such inspections, with NABP being one possibility. 

Currently, Minnesota law (PDF) clearly distinguishes compounding from manufacturing or wholesale distribution. By statute and rule, compounding in Minnesota is 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. 

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.