Sunday, April 19, 2015

Minnesota Board of Pharmacy Issues Urgent and Emergency Veterinary Compounding Guidance

Urgent and Emergency Veterinary Compounding Guidance After discussion with the Minnesota Veterinary Medical Association, and based on staff analysis and recommendations, the Board adopted the following position statement at its March 4, 2015 meeting. “The Minnesota Board of Pharmacy will temporarily exercise enforcement discretion by not requiring a pharmacy to become licensed as a manufacturer when it compounds and distributes a limited supply of veterinary products that are needed in urgent or emergency situations; where the health of an animal is threatened, or where suffering or death of the animal is likely to result, from failure to treat.” The Board also issued the following guidance, pursuant to Minnesota Statutes §214.108, which states that a “health-related licensing board may offer guidance to current licensees about the application of laws and rules the board is empowered to enforce.” Note that this guidance will remain in effect only until the Board can promulgate appropriate rules related to this issue. 1. Pharmacies licensed by the Board can already compound and dispense drugs, pursuant to a patientspecific prescription received in advance of the dispensing, provided that such compounding and dispensing is done according to Minnesota Statutes §151.253 and the applicable rules of the Board. (Note that only those pharmacies that have selected the nonsterile and/or sterile compounding licensing categories are allowed to compound drugs.) Compounding done pursuant to a patient-specific prescription is not the subject of this guidance. 2. The Board will exercise enforcement discretion and not take action against a pharmacy that, in good faith, provides a compounded drug to a veterinarian, at wholesale and without first receiving a patientspecific prescription, only when: a. The compounded drug is needed to treat animals in urgent or emergency situations; that is, where the health of an animal is threatened or where suffering or death of an animal is likely to result from failure to treat. b. Timely access to a compounding pharmacy is not available, as determined by the prescribing veterinarian. c. There is no Food and Drug Administrationapproved, commercially manufactured drug that is suitable for treating the animal; or there is a documented shortage of such drug. d. The compounded drug is to be administered by a veterinarian or a bona fide employee of the veterinarian; or dispensed to a client of a veterinarian in an amount not to exceed what is necessary to treat an animal for a period of five days. e. The pharmacy is licensed by the Board as a drug wholesaler. (Except that a pharmacy may distribute compounded drugs as described in this guidance until June 1, 2015, without being licensed as a drug wholesaler.) f. The pharmacy has selected the sterile or nonsterile compounding licensing category. g. The pharmacy is appropriately registered by the United States DEA when providing compounded products that contain CS.

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