March 15, 2024

OMB concludes review of FDA ‘demonstrably difficult’ proposed rule

On Monday, OMB announced they concluded their review of FDA’s proposed rule on Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A and 503B of the Federal Food Drug and Cosmetic Act and returned the proposed rule to FDA with changes. 

APC and others have raised procedural concerns with FDA proposing categories of drugs for the list prior to the criteria for evaluation being finalized. We’re watching closely for OMB’s changes to be posted in the Federal Register and will update you once we know more. Stay tuned.