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OTC pediculicides

This article was originally published in The Tan Sheet

Executive Summary

FDA announces availability of "background documents" related to the agency's response to two NDMA petitions on the regulation of pediculicides in a Dec. 6 Federal Register notice. In December 1993, FDA published a final rule that announced that FDA would assume the Environmental Protection Agency's role in regulating pediculicides. After NDMA requested a one-year extension of the Dec. 14, 1994 effective date for complying with FDA (and not EPA) labeling requirements for anti-lice products, FDA told the association that extensions would be granted on a case-by-case basis only ("The Tan Sheet" June 27, p. 14). The agency said it is making its correspondence with NDMA publicly available "to ensure that all interested persons are aware of the issues that were raised" by NDMA

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