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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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In Brief

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AER final rule for application OTCs

FDA finalizes its interim final rule requiring application, or non-monograph, OTC products, and all Rx drugs to include toll-free numbers for reporting adverse events on packaging, effective Nov. 28. The rule, which also applies to private-label products, was mandated by the Food and Drug Administration Amendments Act of 2007 (1"The Tan Sheet" Jan. 21, 2008, p. 13). According to an Oct. 28 Federal Register notice, labels should explain the numbers are for AE reporting only. The compliance deadline is July 1, 2009

AER final rule for application OTCs

FDA finalizes its interim final rule requiring application, or non-monograph, OTC products, and all Rx drugs to include toll-free numbers for reporting adverse events on packaging, effective Nov. 28. The rule, which also applies to private-label products, was mandated by the Food and Drug Administration Amendments Act of 2007 (1"The Tan Sheet" Jan. 21, 2008, p. 13). According to an Oct. 28 Federal Register notice, labels should explain the numbers are for AE reporting only. The compliance deadline is July 1, 2009

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