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May 10, 2021
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Fight continues to keep moxifloxacin on the 503B bulk drug list

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WAILEA, Hawaii — During the Hawaiian Eye complicated cataract case section here, Richard L. Lindstrom, MD, updated the audience on the fight to retain moxifloxacin as Category 1 for 503B outsourcing facility use.

Healio previously reported on this in September 2020.

“I was just on the phone with the FDA on that exact topic a week ago trying to convince them to simply make moxifloxacin still available for 503B compounding, because they want to take it away, which would not be in our best interest,” Richard L. Lindstrom, MD, said here at Hawaiian Eye.

Richard L. Lindstrom

“AAO, ASCRS, the Cornea Society, the Retina Society, every society has written to the FDA saying, ‘please don’t do that,’” he said. “Where we are is we are fighting with the government over having what we doctors should be allowed to have, which is having access and choice to do what we think is the right thing for our patients, and our government is trying to take it away.”

Organized ophthalmology is trying to fight it but “we might lose intracameral antibiotics from a 503B facility,” he said, noting that it could still be available from a 503A pharmacy which would require a prescription for each patient.

A 5 mg/mL concentration of moxifloxacin is the most common concentration used for antibiotic prophylaxis of endophthalmitis after cataract surgery.