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OTC VAGINAL DRUG PRODUCT MONOGRAPH PROPOSAL WITHDRAWN BY FDA

This article was originally published in The Rose Sheet

Executive Summary

OTC VAGINAL DRUG PRODUCT MONOGRAPH PROPOSAL WITHDRAWN BY FDA in a notice published in the Feb. 3 Federal Register. The agency said it has decided to withdraw an October 1983 advance notice of proposed rulemaking that would have been the basis for a monograph covering over-the-counter vaginal drug products after determining that "some of the recommended labeling indications and ingredients used for minor irritation, itching or soreness are not unique to the vaginal area and are already being considered" in other OTC rulemakings.

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