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OTC office would have sole responsibility for Rx-to-OTC switches under PhRMA draft bill.

This article was originally published in The Tan Sheet

Executive Summary

FDA OTC OFFICE WOULD HAVE SOLE RESPONSIBILITY FOR Rx-TO-OTC SWITCHES and all other matters related to OTC drugs under draft FDA reform legislation recently prepared by the Pharmaceutical Research and Manufacturers of America (PhRMA). The draft legislation states that "all applications or petitions requesting that a drug be switched from prescription to nonprescription status and all other matters relating to nonprescription drugs shall be reviewed and acted upon solely by a single office in the center for drugs, and that office shall report directly to the center director."
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