US FDA Forecasts Monograph Program Activities As Overhaul Transitions From Construction Phase

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.

The list published on 30 September, the fourth for the program, likely will be the final annual nonbinding forecast under the first five-year authorization of the OTC monograph user fee program (OMUFA) Congress included in the 2020 legislation authorizing an overhaul of the FDA’s regulatory