Compounding for animal patients: contemporary issues.

OBJECTIVES: To provide background information relating to the growth observed in veterinary compounding, discuss positive contributions made to animal health via compounding, present compounding practices that are in the best interest of patient care, present documents available to pharmacists to use for guidance when practicing veterinary pharmacy, and emphasize the need for education among stakeholders on the subject of veterinary compounding. DATA SOURCES: The Animal Medicinal Drug Use Clarification Act of 1994, compliance policy guide section 608.400, the American Veterinary Medical Association Position Statement on Compounding and Extralabel Drug Use Algorithm; supporting data from veterinary and pharmacy literature documenting the practice of veterinary compounding are referenced (SilverPlatter Medline 1966-2002 and International Pharmaceutical Abstracts; 1970 through December 2002; no restrictions; search terms, veterinary AND compounding). STUDY SELECTION: By the author. DATA EXTRACTION: By the author. DATA SYNTHESIS: Requests for compounding of products for veterinary uses are common in community pharmacy, and these preparations fill many clinical, dosing, and drug-administration needs in the care of companion animals. However, like other elements of pharmacy compounding, preparation of veterinary products falls into a legally gray area that is the subject of current scrutiny by the U.S. Food and Drug Administration (FDA). Pharmacists involved in this practice should keep the best interests of the animal in mind; recognize limitations about safety, effectiveness, and stability of compounded formulations; and avoid preparing products similar in ingredients and purpose as commercially available, FDA-approved products. Situations in which compounding becomes manufacturing invites enforcement action by FDA. The dispensing of compounded products should be based on a valid veterinarian-client-patient relationship and comply with federal acts, FDA's compounding compliance policy guide, and other such resources.
CONCLUSION: All pharmacists and pharmacies engaged in any type of veterinary pharmacy practice must be aware of the contemporary issues facing their profession. Best patient care practices, education, and open communication among stakeholders will play a critical role in the practice and future regulation of veterinary compounding.