On May 21, the FDA released a draft “Guidance for Industry (GFI) #230, Compounding Animal Drugs from Bulk Drug Substances.” The guidance outlines specific conditions under which the agency generally does not intend to take action against state-licensed pharmacies, veterinarians, and facilities registered as outsourcing facilities when drugs are compounded for animals from bulk drug substances.
This week, mymedsmatter.com released results of a survey of veterinary practices that administer and prescribe customized medications for their patients. A coalition of compounding pharmacies that specialize in veterinary medicine commissioned the research to learn how practicing veterinarians would be affected if they were to apply FDA’s guidelines as detailed in the draft proposal.
The survey results, based on 2,359 veterinary professionals in the United States, indicate a high percentage of veterinarians believe their practices would be negatively affected by the proposed guidance.
For 99 percent of respondents, access to compounded medications when they are necessary in their medical judgment is important, while 90 indicated it “very important.” Ninety-four percent of respondents indicated their ability to maintain office stock of compounded medications to be administered as needed to patients is important or very important to their patients’ health and medical outcomes.
While the FDA’s guidance recommends eliminating office use of compounded medications from compounding pharmacies, 89 percent of respondents say that they order compounded medications compounding pharmacies for office stock, which they administer to patients often in emergency situations. In states that require patient-specific prescriptions for compounded medications, 78 percent say that this restriction has a negative impact on their ability to practice medicine.
Among respondents to the survey, 73 percent practice in small businesses with four or fewer veterinarians and 72 percent treat primarily companion animals.
The full report is available online from MyMedsMatter.com.