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: 7) Cyclosporin(e) - In dogs, immune-mediated ocular surface disease (various types of conjunctivitis, various types of keratitis, dry eye disease) is common, often severe, often difficult to control, and can lead to discomfort, severe corneal opacification, corneal ulcers or perforations, vision loss, or loss of the eye. In cats and horses, immune-mediated ocular surface disease (eosinophilic keratitis, IMMK, other) is less common but still frequently observed in the veterinary ophthalmology specialty practice setting. Although some patients may respond to commercially available ophthalmic cyclosporine (Optimmune), patients presenting to veterinary ophthalmologists have often already failed “first-line” therapy with this drug or, for dogs and cats, the patients did not tolerate the administration of the ophthalmic ointment formulation. In order to allow for adequate compliance, avoid delays in necessary therapy, and promote improved treatment outcomes, it is essential to have compounded ophthalmic cyclosporine formulations available for in-office use. 8) Diclofenac sodium - 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). 9) Cidofovir – While feline herpesvirus-1 (FHV-1) is typically a self-limiting disease, this is not always the case. In these patients, FHV-1 can cause ocular pain, severe conjunctivitis, severe corneal ulcers or perforations, symblepharon, blindness, and loss of the eye without appropriate and timely anti-viral therapy. Although commercially available famciclovir is an excellent treatment option, this large and bitter pill is not tolerated by many cats. As such, poor compliance leads to negative outcomes for the patient. As such, compounded ophthalmic preparations of cidofovir available for in-office use are often the treatment of choice in cats with this disease; this leads to improved medication administration compliance and lower stress for the patient (which is an important component of FHV-1 therapy), and this avoids delay in treatment (which would be caused by waiting for a patient-specific prescription to be ordered and mailed).