APC Advocacy

503A and 503B Bulks Lists

The issue

The FDA has accepted nominations for substances for which there is a clinical need for compounding. Through an interim guidance document, the agency established criteria by which they will allow compounding by outsourcing facilities of some of the nominated substances while the list is finalized.

APC has expressed concerns that FDA’s review of nominated substances for 503B bulks list has taken a very restrictive view of the “clinical need” determination in a way that greatly favors the use of finished, manufactured product in compounding over bulk ingredients.