Guidance on the Compounding of Veterinary Drugs
The Minnesota Board of Pharmacy staff have held discussions with representatives of the Minnesota Veterinary Medical Association and the Minnesota Board of Veterinary Medicine about the issue of compounding drugs for use in urgent and emergency situations. Based on these discussions, the Board of Pharmacy is issuing the following guidance:
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.
- 1. Pharmacies licensed by the Board can already compound and dispense drugs, pursuant to a patient-specific prescription received in advance of the dispensing, provided that such compounding and dispensing is done according to MN Stats. Â§151.253 and the applicable rules of the Board. (Note that only those pharmacies that have selected the non-sterile 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.
- 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 patient-specific prescription, only when:
- 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.
- Timely access to a compounding pharmacy is not available, as determined by the prescribing veterinarian.
- There is no FDA-approved, commercially manufactured drug that is suitable for treating the animal; or there is a documented shortage of such drug.
- 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.
- 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).
- The pharmacy has selected the sterile or non-sterile compounding licensing category.
- The pharmacy is appropriately registered by the United States Drug Enforcement Administration when providing compounded products that contain controlled substances.
Cody Wiberg, Pharm.D., M.S., R.Ph.
Minnesota Board of Pharmacy
The above information is a summary. For a complete copy of the guidance document and background information developed by the Minnesota Board of Pharmacy please contact the MVMA office (615-645-7533 or email@example.com) If you are continuing to have problems accessing compounded drugs relative to the issuance of this directive from the Board of Pharmacy please contact the MVMA or the Minnesota Board of Pharmacy.