Today, the FDA released the final guidance, “Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and 3 Cosmetic Act,” which addresses FDA policies for developing the 503B Bulks List and how it intends to evaluate nominating bulk drug substances. The 503B Bulks List identifies bulk substances that may be used by 503B outsourcing facilities for compounding. The FDA maintains that outsourcing facilities must use FDA-approved drug products for compounding unless it is demonstrated there is a “clinical need” to compound using a bulk drug substance, or if the drug compounded appears on the FDA’s drug shortage list. In ASCRS comments on the proposed guidance, we expressed concern that compounding from an FDA-approved product presents more risk because there are many unknowns in terms of resultant pH, stability, and osmolality that could lead to dangerous drug interactions that may have the potential to harm patients. Additionally, we explained that they are many situations, considered standard of care, such as long-term use of preservative-free compounded medications for glaucoma patients that need to be compounded from bulk drug substances.
ASCRS plans to comment on the final guidance. We will keep you updated.