Comment from Hays Veterinary Hospital, PA - Mark A. Meier, DVM (Owner)

I knew this would happen. I said it in my last comment. This ridiculous regulatory capture / overreach of compounded medication (pimobendan). A patient just died because they have been without heart medications for a month because we were waiting for their prescription to be compounded individually. We used to be able to have the medication compounded for in office use and keep it on hand before this short-sided FDA guidance went into effect. Pimobendan is a medically necessary pharmaceutical that is needed for patients with heart disease. Pimobendan works by helping the heart pump blood more efficiently throughout the body by increasing contractility of the heart muscle and dilating the veins and arteries. The tiny tablet formulation that we kept in office from the compounding pharmacy is necessary because a majority of dogs with heart disease are small breeds and are difficult to pill and/or are picky eaters. When comparing the tiny tablet formulation to the FDA-labeled medication (Vetmedin - by BI), the size difference of the tablets are significant. When pimobendan tiny tablet formulations were available for office use, a 500 count bottle would be in a 60 dram bottle. BI sells Vetmedin as 50 tablets in a 30 dram bottle. Use that as a size comparison. Anyways a patient has died now in part on the owner for not planning ahead for their pet's medications to run out, and for us not being allowed to carry the medication on-hand in the office for a situation such as this. FDA regulation for the win. Please allow pimobendan to be compounded for office use. Sincerely, Dr. Mark A. Meier Hays Veterinary Hospital