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USP Suggests “Group Monographs” To Augment OTC Drug Review

This article was originally published in The Tan Sheet

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.

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