Ophthalmologists Urge FDA to Create Exemption for Compounding of Office Stock

Three eye surgeons asked FDA officials May 21 to create an exemption that would allow ophthalmologists to obtain certain compounded drugs for office stock from state-regulated pharmacies, an action that is currently banned.

The surgeons were the only doctors from any specialty to speak at an FDA public hearing to review regulations for compounding of office stock.

They said current laws are limiting their ability to treat patients in emergency situations. Approved antibiotics, antivirals, and antifungals for certain eye emergencies don’t exist, and the doctors are no longer able to get eye-appropriate compounded versions for office stock at state-regulated 503A pharmacies, as they have in the past.

The doctors said they keep small quantities of these formulations on hand and replace them regularly as they expire.

The Drug Quality and Security Act of 2016 prevents 503A pharmacies from compounding drugs for office stock; pharmacies must have a patient-specific prescription. The law shifts compounding of office stock to the new category of 503B outsourcing facilities, overseen by the FDA and held to the same lengthy and expensive testing requirements as drug manufacturers.

The doctors said the 503B outsourcing facilities won’t make the drugs they need in small quantities due to the expense.

Cornea specialist David Glasser, MD, represented the American Academy of Ophthalmology; cornea specialist Damien Goldberg, MD, spoke for the American Society of Cataract and Refractive Surgery; and retina specialist John Thompson, MD, made a presentation for the American Society of Retina Specialists.

The drugs they need customized for eye use include acyclovir, amikacin, amphotericin, clindamycin, foscarnet, gancyclovir, and voriconazole.

Intravitreal formulations of two antibiotics, vancomycin and ceftazidime, are available from 503B facilities for bacterial endophthalmitis, Thompson said, but there are no 503B-available agents for fungal or viral infections or for when a patient is allergic to vancomycin or cephalosporins.

Glasser said non-ocular drugs cannot be used in the eye without customization because they contain preservatives or they’re the wrong concentration.

He said there is a strong argument to be made that the risk of vision loss in patients who cannot get a needed drug in an emergency is greater than the risk of harm from a contaminated drug compounded with less testing.

Thompson said some retina specialists may return to do-it-yourself mixing of antibiotics, as they did 20 years ago, with little training and below-standard techniques. He said this would represent a major step backward in safety.

Goldberg said his busy cornea practice in Los Angeles may see four patients needing one of these drugs per year; a practice’s compounding needs for emergencies are small but critical.

Robert P. Nickell, CEO of outsourcing facility Nubratori Rx, in Torrance, California, spoke at the hearing and said he has turned down a request by Goldberg to compound these drugs because the cost per drug could run as high as $1 thousand per bottle for a product that likely would be thrown away, and doctors can’t get reimbursed for these drugs.

Another representative for outsourcing facilities said at the end of the meeting that having all the stakeholders in the same place at the same time already had led to productive suggestions during the lunch break.

FDA officials did not provide a timeline for when they might act on the ophthalmologists’ request for an exemption.