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AER final rule for application OTCs

This article was originally published in The Tan Sheet

Executive Summary

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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