Frequently Asked Questions for Pharmacists on Compounding for Animal Patients
MONDAY, JUNE 15, 2015
FDA Issues Draft Guidance on Use of Bulk Substances In Compounding for Animal Patients. On May 19, 2015 the Center for Veterinary Medicine of the Food and Drug Administration (FDA CVM) issued a draft Guidance for Industry (GFI) #230 Compounding Animal Drugs From Bulk Drug Substances and rescinded Compliance Policy Guide (CPG) 608.400 Compounding of Drugs For Use In Animals. CPG 608.400 has been in effect since its inception in 1996 and was revised in 2003. FDA CVM issued GFI #230 in response to sweeping changes in compounding regulation caused by the Drug Quality and Security Act of 2013 in order to bring regulatory enforcement for animal compounding more in line with that for humans. GFI #230 now represents FDA CVM’s current thinking on use of bulk drug substances when compounding for non-human patients.
Board staff thanks Gigi Davidson, BSPh, DICVP, Director of Clinical Pharmacy Services at the NC State College of Veterinary Medicine, for preparing this summary and FAQ guidance. Gigi also serves as Chair of the USP Compounding Expert Committee. Draft Guidance /FAQs on Use of Bulk Substances In Compounding for Animal Patients.