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FDA In Brief

This article was originally published in The Rose Sheet

Executive Summary

OTC drug labeling: FDA's toll-free MedWatch number will be required on all non-monograph OTC drug products, effective April 22, 2005, agency announces. Published April 22 in the Federal Register, the proposal recommends the statement be placed in the "Warnings" section of the Drug Facts panel, under the "Stop Use and Ask a Doctor If" subheading. FDA is recommending that the side effects statement first direct consumers to consult a doctor for medical advice if side effects occur. The labeling addition is required under Best Pharmaceuticals for Children Act, which became law in 2002. The agency estimates 522 OTCs will be subject to the rule, and predicts OTC drug manufacturers will incur a one-time cost of $1.2 mil.-$3.7 mil., depending upon the number of affected SKUs...

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