FDA Busy Sorting OTC Monograph Ingredients Anticipating System Overhaul

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.

FDA still is categorizing ingredients in its existing OTC drug monograph program so it would hit the ground running if Congress passes legislation to dramatically streamline its process for deciding whether an ingredient, indication or dosage format is generally regarded as safe and effective, says Theresa Michele, the agency's nonprescription drug products chief.

At the Consumer Healthcare Products Association’s Regulatory, Scientific & Quality Conference in Washington on May 18, Michele said assigning monograph...