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Plan B Rulemaking Intended To Establish Enforcement Procedures – Crawford

This article was originally published in The Tan Sheet

Executive Summary

The question of how to enforce an age-limit for OTC availability of Barr Labs' Plan B - rather than whether dual status for the drug could exist at all - was the main driver behind FDA's initiation of a rulemaking on the Rx-to-OTC switch application for the emergency contraceptive, according to former FDA Commissioner Lester Crawford

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