Comment from Kendall McDaniel

I am concerned that the proposed requirements related to this regulation will have significant negative effects on veterinary practices and compounding pharmacies, particularly high-volume clinics and small businesses. As written, this regulation should not move forward. The operational and financial burden of compliance is underestimated. High-volume clinics will experience meaningful losses in efficiency due to increased documentation and reporting requirements, diverting staff time away from patient care. These time losses translate directly into financial strain, and many practices would be forced to substantially revise or completely overhaul existing policies and procedures in order to comply. For already stretched clinics and pharmacies, this represents a costly and disruptive change with limited demonstrated benefit. More broadly, this guidance places substantial restrictions on veterinary compounding without a clear congressional mandate, limiting veterinarians’ clinical judgment and restricting access to necessary compounded medications. Compounded drugs are essential in veterinary medicine when FDA-approved options are unavailable or inappropriate for individual patients. If FDA proceeds, this regulation should be significantly revised to reduce unnecessary burden, improve transparency, incorporate appropriate subject matter expertise, and respect the realities of veterinary practice. As currently proposed, the regulation imposes high costs in time, efficiency, and operational change with unclear practical benefit, and therefore should not be adopted.