FDA Busy Sorting OTC Monograph Ingredients Anticipating System Overhaul
This article was originally published in The Pink Sheet & The Rose Sheet
Executive Summary
FDA has yet to finalize about one-third of its OTC monographs and several hundred ingredients do not have a final GRASE determination. Sorting will help the agency determine which of the 800 active OTC monograph ingredients are designated as needing more information to establish GRASE under a faster system based on administrative orders.