FDA Corrects Proposal to Amend Monograph for OTC Bronchodilator Drug Products

Summary

The Food and Drug Administration (FDA) is correcting a proposal that proposed to remove pressurized metered-dose aerosol container dosage forms for the ingredients epinephrine, epinephrine bitartrate, and racepinephrine hydrochloride from the final monograph for over-the-counter (OTC) bronchodilator drug products, which was published with errors.