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OTC cough/cold dosing proposal on FDA agenda

This article was originally published in The Tan Sheet

Executive Summary

FDA plans to publish a proposed rulemaking regarding pediatric dosing of OTC cough/cold products in June 2010, according to the Department of Health and Human Services' semi-annual regulatory 1agenda published Dec. 7. The agency intends to publish in May a final rule on the OTC sunscreen monograph and a final rule for OTC weight-control products containing benzocaine, and in September a proposed rule regarding OTC antihistamine labeling claims for the common cold. Other longer-term actions with undetermined completion dates include a proposed rule on oral care products to reduce or prevent plaque and gingivitis, and a final action on OTC drugs containing bismuth subsalicylate for relieving upset stomach caused by overeating. The HHS agenda released in May targeted September for the pediatric cough/cold and sunscreen actions (2"The Tan Sheet" May 25, 2009). Regulatory agendas are not binding on agencies and often list repeatedly delayed rulemakings
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