In a follow-up meeting Wednesday with APC leaders, the FDA’s Center for Veterinary Medicine’s Dr. Bill Flynn acknowledged that questions raised by APC about the practical implications of certain provisions of GFI #256 may result in tweaks to the document, reiterating that the agency was focused on making it a GFI that works and does not impede animal healthcare.

APC had shared with CVM in advance a list of questions, seeking to understand how FDA intends to enforce certain provisions of the GFI.

“While we continue to question the agency’s authority to regulate animal drug compounding via this GFI, we do understand the positive role a well-structured GFI could play in protecting animal health,” APC’s Scott Brunner told CVM officials in the meeting. “But we’re just not yet confident that you’ve fully vetted the implications of this GFI, and we believe without some amendment and clarifications, it’s premature to finalize it.”

A few highlights of the conversation:

• To tutor compounders on the provisions of the GFI, CVM pointed to this Checklist for Pharmacists: Compounding Animal Drugs and to this online resource for nominators in submitting substances for the office-administration bulks list.
• CVM’s Flynn noted that the bulk compounding list to be created under the GFI was for office-administration compounds only, and not for patient-specific compounding.
• Related to questions about ambiguity in the definition of adverse events in the GFI, CVM said they would expect reporting on “atypical reactions that are not known side effects.” APC urged a more specific, robust definition, saying, “Too ambiguous a definition will lead to reporting of huge amounts of useless information on routine effects that will cast the compounder in a negative light.”
• APC also raised liability concerns about beginning with a manufactured drug for which the pharmacist only knows the active ingredient. “What is the compounder’s liability – or FDA’s liability when an adverse event occurs as a result of an excipient the compounder did not know was in the manufactured drug?” an APC leader asked.
• APC urged CVM leaders to engage NABP and conduct training on the GFI for state boards of pharmacy to help align state policies with FDA’s intentions.

The leaders agreed to continue the dialogue on this issue in coming days.