This week, ASCRS sent a letter to the Food and Drug Administration (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 traditional compounding facilities. This letter was in response to a revised FDA draft guidance, “Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act,” that attempted to address our concerns with policies related to office-use that require a physician to obtain a compounded drug from an 503B outsourcing facility if he or she does not have a patient-specific prescription. ASCRS expressed that while the revised policies may allow outsourcing facilities to produce smaller batches of compounded drugs more easily, the access issue will not be resolved since outsourcing facilities remain unwilling to compound in the small quantities needed by ophthalmologists to treat patients with emergent conditions.
The FDA will hold a public meeting on May 21, 2019, to solicit comments from stakeholders on the potential impact the policies will have on compounded drugs for office-use from outsourcing facilities. ASCRS will attend and provide a statement during the meeting. We will keep you updated.