FDA Lists Planned OTC Monograph Activities for Next Three Years

The FDA posted its second annual forecast of planned over-the-counter (OTC) monograph activities, adding two new items to the list for the next three years.

The agency’s OTC drug monographs establish conditions such as active ingredients, indications, doses, routes of administration, labeling and testing, under which an OTC drug in a given therapeutic category is generally recognized as safe and effective (GRASE) for its intended use.

The nine-item list now includes planned safety orders on the GRASE status of ipecac labeled for poison treatment and dosing for pediatric cold/cough products. Other planned topics include the risks associated with codeine‐containing cough medicine and pediatric acetaminophen dosing.

Read the annual forecast here: bit.ly/3fxuRoa.