USP Suggests “Group Monographs” To Augment OTC Drug Review
This article was originally published in The Pink Sheet Daily
Executive Summary
Compiling drug product monographs, “particularly for the ever-changing” OTC monographs, “has proved daunting,” USP says in comments to FDA. The organization says “group monographs” would be defined by applicability to assay and impurity procedures and those for identity.