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Pain relievers label final rule not ready

This article was originally published in The Tan Sheet

Executive Summary

FDA says it "inadvertently, mistakenly posted" a Jan. 23 pre-publication notice indicating that a final rule for OTC internal analgesic product labels would be published in the Jan. 26 Federal Register. The rule would amend labels for non-steroidal anti-inflammatory drugs and acetaminophen-containing products to include warnings of gastrointestinal and liver injuries associated with improper use (1"The Tan Sheet" Jan. 26, 2009, In Brief). FDA announced the posting error Jan. 26, but did not say when the rule will be published

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Final rule for pain reliever labels

FDA has prepared a final rule to require that acetaminophen-containing and non-steroidal anti-inflammatory OTC drugs carry updated warnings on adverse gastrointestinal and hepatic side effects linked to improper use. The 1rule slated for publication in the Jan. 26 Federal Register amends FDA's labeling regulations and the tentative final monograph on nonprescription internal analgesic, anti-pyretic and anti-rheumatic drug products. The compliance deadline is one year from the date of publication. FDA's December 2006 proposed rule raised industry concerns that more flexibility was needed and that some of the changes were not supported by science (2"The Tan Sheet" June 11, 2007, p. 3). While some of the Consumer Healthcare Products Association's comments were not adopted for the rule, the trade group said Jan. 23 that its members already voluntarily have implemented "many of these label changes," including highlighting the active ingredient





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