USP Suggests “Group Monographs” To Augment OTC Drug Review

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.

The U.S. Pharmacopeia suggests using “group monographs” defined by testing procedures to augment FDA’s current OTC monograph system defined by drug indications and the testing organization’s own drug ingredient compendium.

USP’s recommendation, in its comment to FDA on improving the agency’s over-the-counter drug review process, is similar to...