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FDAAA Requires Toll-Free Number For Side Effect Reports On Application OTCs

This article was originally published in The Tan Sheet

Executive Summary

A rule mandated by the FDA reauthorization Congress passed in 2007 that requires a toll-free number for reporting side effects on packaging for non-monograph OTC products and all Rx drugs went into effect Jan.1, but the agency likely will not enforce it until 2009

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