APC: Hey CVM, we have a few more questions…

April 21, 2023

Hey CVM, we have a few more questions…

APC this week asked FDA’s Center for Veterinary Medicine to provide additional guidance on compliance with its GFI 256 on animal drug compounding. In a letter to the CVM’s Dr. Bill Flynn, APC raised several issues that have come up in our training sessions for members. 

The letter asks CVM to clarify whether compounded drugs should be allowed when a drug is not available due to supply chain issues or backorders. The FDA had previously said that compounders should contact the agency in case of a drug shortage but that the agency does not provide blanket enforcement discretion for compounding copies of drugs in shortage.

The letter also takes issue with CVM’s assertion that compounders are expected to know what ingredients may be harmful or cause side effects to the species for which the drug is being compounded. 

“Because they are not listed in the approved package insert, it simply is not possible for pharmacists to know the excipients in manufactured animal drug products,” the letter states.