Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use; Amendment of Monograph for OTC Bronchodilator Drug Products

Resumo

The Food and Drug Administration (FDA) is amending the final monograph for over-the-counter (OTC) bronchodilator drug products by removing pressurized metered-dose aerosol container dosage forms for the ingredients epinephrine, epinephrine bitartrate, and racepinephrine hydrochloride. This action is being taken because the OTC marketing of such drug products will require an approved application containing certain information not required by the monograph. The agency is also amending the regulation that lists nonmonograph active ingredients by adding any ingredient(s) in a pressurized metered-dose aerosol container for OTC bronchodilator drug products. This final rule is part of the ongoing review of OTC drug products conducted by FDA.