Tests On Professional Antiseptics Could Influence Consumer Hand Wash Market
Executive Summary
Responding to industry's requests, US FDA's rulemaking on six health care personnel antiseptics remaining in the OTC drug monograph is delayed one year to allow firms to demonstrate the ingredients are GRASE. ACI says the research could impact whether ingredients remain available for consumer hand washes.
You may also be interested in...
Rulemaking For OTC Switch Process Changes Pushed To 2019
Target date moved from August 2018 to February 2019 for publishing an NPRM for allowing currently Rx drug ingredients to be available nonprescription under conditions of safe use. US HHS annual spring update on regulatory priorities for FDA and its other agencies also pushes back target dates for other OTC drug NPRMs, including FDA's long-delayed finalization of several monographs including sunscreen ingredients.
Rulemaking For OTC Switch Process Changes Pushed To 2019
Target date moved from August 2018 to February 2019 for publishing an NPRM for allowing currently Rx drug ingredients to be available nonprescription under conditions of safe use. US HHS annual spring update on regulatory priorities for FDA and its other agencies also pushes back target dates for other OTC drug NPRMs, including FDA's long-delayed finalization of several monographs including sunscreen ingredients.
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.