ASCRS FDA Committee Member Speaks on Access to Compounded Drugs

ASCRS FDA committee member Damien Goldberg, MD, urges FDA to allow access to compounded drugs from traditional compounders without a patient-specific prescription.

During an FDA public meeting this week, Damien Goldberg, MD, a member of the ASCRS FDA Committee, joined with the ophthalmic community and urged the FDA to ensure ophthalmologists have a pathway to obtain compounded drugs for office-use by allowing physicians to obtain small quantities of drugs needed to treat emergent conditions without a patient-specific prescription. The meeting was hosted in response to a revised FDA draft guidance, “Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act," which attempted to address ASCRS concerns with policies related to office-use that require a physician to obtain a compounded drug from a 503B outsourcing facility if he or she does not have a patient-specific prescription. 

Dr. Goldberg explained that while the revised draft guidance may allow outsourcing facilities to compound small batches, the majority of outsourcing facilities have indicated that they do not intend to change their current practices and will not compound to fill small-volume orders that ophthalmologists need for office-use drugs. Representatives from the American Academy of Ophthalmology and the American Society of Retina Specialties echoed our concerns and urged the FDA to prioritize the needs of patients with emergent conditions by allowing physicians to access compounded drugs for office-use from 503A compounding pharmacies in limited supply without a patient-specific prescription. We will keep you updated.

View the full article by ASCRS

Professional Disclosure: Dr. Goldberg is the Chief Medical Officer at Ocular Science® (an OSRX affiliate) and has a financial interest in the company.

OSRX operates in full compliance with Section 503A regarding compounded drugs as defined in the FD&C Act.

*Compounded drugs are not FDA-approved, which means they have not undergone FDA premarket review for safety, effectiveness, and quality. 503A compounding pharmacies are not required to comply with cGMP requirements but can be inspected by FDA. References available upon request.

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