Ophthalmic organizations request FDA reconsider moxifloxacin removal from 503B bulk list
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Several major ophthalmic organizations requested the FDA reconsider its intention to remove moxifloxacin from the 503B bulk drug list, which identifies drug substances for which there is a clinical need.
The American Academy of Ophthalmology, the American Society of Cataract and Refractive Surgery, the American Glaucoma Society, the American Association for Pediatric Ophthalmology and Strabismus, the American Society of Retina Specialists, the Retina Society, the Macula Society and the Cornea Society formally requested the FDA retain moxifloxacin as Category 1 for 503B outsourcing facility use, according to a joint letter from the organizations.
A 5 mg/mL concentration of moxifloxacin is the most common concentration used for antibiotic prophylaxis of endophthalmitis after cataract surgery. In a 2019 ASCRS survey, half of respondents said they used intracameral antibiotics as part of their endophthalmitis prophylaxis regimen, according to the statement.
“Although we understand the FDA’s desire to promote the use of approved products as the basis for compounded products to protect the health of our patients, we believe that public safety will be reduced by loss of access to bulk moxifloxacin,” the statement said.
The organizations wrote there is only one manufactured moxifloxacin at 5 mg/mL finished drug product, topical Vigamox (moxifloxacin ophthalmic solution 0.5%, Novartis), and its authorized generic, Sandoz moxifloxacin 0.5% (Novartis). Vigamox is not approved for intraocular use and is not required to be compliant with USP <789>, which deals with particulate matter for ophthalmic solution or injectables.
If moxifloxacin is removed from the list, repacked moxifloxacin 5 mg/mL will be made by 503A pharmacies or by an individual surgeon’s preparation. Complications can arise from misuse of compounded moxifloxacin at too high a dose or prepared from an incorrectly formulated source product. These issues have not been associated with the quality of product from 503B facilities, according to the joint statement.
Moxifloxacin and ketorolac are two of 19 bulk drug substances the FDA is considering to not include on the list of active pharmaceutical ingredients.
Compounded moxifloxacin and ketorolac are used in a number of ophthalmic procedures and therapeutics. Moxifloxacin can be injected after cataract surgery as an antibiotic prophylaxis, and ketorolac is a common NSAID used preoperatively and postoperatively for ophthalmic procedures.
The FDA is accepting comments and input on the proposed changes. Comments are due by Sept. 29.
Perspective
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William F. Wiley, MD
Over recent years, ophthalmologists have integrated with greater frequency the use of compounded medications as part of their cataract surgery protocols to help increase the safety profile as it has been thought that intraoperative antibiotics can reduce infection. Currently, there are no commercial antibiotics labeled for intraocular use; thus, providers have resorted to compounding to fill this void. In addition to compounded medications, ophthalmologists have helped innovate this space with new commercially available medications; however, even with commercial innovation, compounded medication remains a large part of many providers perioperative regimen. To respond to the high demand of compounded medications, 503B compounding facilities have served ophthalmologists and their patients in a safe and regulated manner. 503B compounded medications have provided a great supplement and/or alternative to commercially available products. Furthermore, ophthalmologists have learned through reported/shared experiences that self-compounding one’s own medications or using commercially available medications off label can not only cross legal and ethical boundaries but it can also lead to adverse outcomes.
With that said, one of the most common options ophthalmologists have at their disposal for specialty ordered not commercially available ocular medication is 503B compounding. 503B compounded medication brings a secure level of guidelines via cGMP manufacturing that would not be available via self-compounding or 503A facility compounding.
I believe that the proposed exclusion of moxifloxacin HCl and ketorolac tromethamine from the 503B bulk list will negatively affect both physicians and patients. Physicians regularly use both active ingredients, which are compounded for intraocular injection from an FDA-registered outsourcing facility and not available commercially. Physicians have benefited from the quality of the cGMP products manufactured at 503B facilities. There is a potential that removal of active pharmaceutical ingredients from the 503B list will encourage the off-label use of similar topical drugs not intended for intraocular injections, and these may not be as safe and effective. There are first heard firsthand reports of surgeons using self-compounded commercially available Moxeza via off-label injections resulting in disastrous side effects.
Thousands of patients are benefiting from intraocular injections every year, and removal of these bulk ingredients from the 503B list will prevent these patients from receiving the benefits of these medications. Doctors will continue to innovate new solutions for intraocular administration for their patient base. As techniques change and adapt to the evolving environment, it will be important for patients to have access to physician-ordered medications. It is important that patients receive these medications from highly regulated environments such as 503B facilities when they are not commercially available in the necessary concentrations or combination.
In summary, I disagree with the proposal to not include these two important active pharmaceutical bulk ingredients on the 503B list and highly recommend that they remain on the list so that patients and physicians can continue to have access to these much needed and very important drugs.
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