As we reported last week, ASCRS submitted comments to the FDA urging it to ensure ophthalmologists have a pathway to secure compounded drugs for office-use by allowing physicians to access small quantities of compounded drugs needed to treat emergent conditions without a patient-specific prescription from 503A compounding facilities. This letter was in response to a revised FDA draft guidance for compounding practices in 503B outsourcing facilities that attempted to address our concerns with policies related to office-use that require a physician to obtain a compounded drug from an outsourcing facility if he or she does not have a patient-specific prescription by revising requirements related to stability testing, including flexibility in the assignment of beyond-use date (BUD), and testing requirements related to batch release. However, ASCRS is concerned that the revisions made in the revised draft guidance do not address the barriers in securing ophthalmic compounded drugs because many outsourcing facilities have indicated that it is not cost-effective to compound small-volume orders that ophthalmologists need for office-use drugs to treat emergent conditions.
ASCRS and the ophthalmic community are advocating together to ensure ophthalmologists have a pathway to obtain compounded drugs for office-use. Each organization plans to provide comments at the FDA public meeting on May 21, 2019, on the impact these policies will have on access to office-use drugs compounded by outsourcing facilities. We will keep you updated.