Comment from Tara Czepiel

Docket No. FDA-2018-N-4626 for “Lists of Bulk Drug Substances for Compounding: Office Stock Drugs for Use in Nonfood-Producing Animals or Drugs for Use in Food-Producing Animals or Free-Ranging Wildlife Species.” I am a veterinary ophthalmologist (DVM, DACVO), and compounded medications available for in-office use/dispensing are an essential component of rapid and effective therapy of ocular disease, improved treatment outcomes for ocular disease, and better medication administration compliance by the clients. I strongly recommend that the following bulk drug substances currently under review be permitted for office use: 10) Flurbiprofen - In horses, administration of eye drops (ophthalmic solutions or suspensions) is notoriously difficult-to-impossible and, potentially, unsafe (due to a large animal resisting or reacting negatively to the sudden sensation of a drop on the ocular surface) for both the patient and the handler/owner. Although the use of a subpalpebral lavage system allows for easier and safer administration of eye drops and, therefore, may address some of the above administration barriers, placement of this system requires a sedated surgical procedure that carries its own risk of complications/sequelae, is only indicated in select disease conditions, and is only indicated for shorter-term use (typically in a hospital or long-term care setting but not an at-home setting). As such, ophthalmic ointments are often the preferred formulation; these allow for improved compliance, better treatment outcomes, and greater patient/handler safety. Since inflammatory ocular disease (uveitis) often progresses quickly and any delay in therapy can lead to blindness, pain, and systemic issues (like colic), it is strongly preferable to begin treatment immediately with an ointment anti-inflammatory medication permitted for office use (instead of waiting for a patient-specific prescription to be ordered and mailed).