Nonprescription drugs are available in the US “non-application,” or without premarket approval, by complying with the Food and Drug Administration’s OTC monograph for formulations, indications and delivery formats.
US FDA Wants Six-Month Premarket Notice Before Manufacturers’ First Monograph OTC Launches
Agency wants time to ensure compliance with GMP regulations before drug makers, such as an Indian firm which provided artificial tear eye drops currently on recall in the US after the products were linked to serious adverse events, distribute OTC monograph drugs for the first time.
