Codeine’s status as an OTC drug under US federal regulations continues as an item on the Food and Drug Administration’s latest annual list of planned OTC monograph activities it intends to initiate over the next three years.
US FDA Forecasts Monograph Program Activities As Overhaul Transitions From Construction Phase
Nonbinding forecast, fourth for the program, includes risks associated with codeine-containing cough medicine as a topic FDA will include in ongoing evaluation of GRASE for pediatric cough cold drug products marketed under monograph for cold, cough, allergy, bronchodilator and anti-asthmatic OTC drugs.
