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Inactive ingredients

This article was originally published in The Tan Sheet

Executive Summary

FDA considering allowing additional public comment for provisions on the labeling of inactive ingredients in its pending final rule on OTC label reform, the agency announces in an updated guidance on OTC ingredient listings. The document clarifies FDA's implementation plans for provisions of the FDA Modernization Act dealing with active and inactive ingredients. A draft of the guidance was inadvertently published in the April 9 Federal Register ("The Tan Sheet" Feb. 23, p. 4). The new version is available on the agency's Web site (www.fda.gov)...
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