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Rulemaking For OTC Switch Process Changes Pushed To 2019

 
• By Malcolm Spicer

Target date moved from August 2018 to February 2019 for publishing an NPRM for allowing currently Rx drug ingredients to be available nonprescription under conditions of safe use. US HHS annual spring update on regulatory priorities for FDA and its other agencies also pushes back target dates for other OTC drug NPRMs, including FDA's long-delayed finalization of several monographs including sunscreen ingredients.

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FDA has pushed back the target date for the first step of rulemaking to change its rules for evaluating Rx-to-OTC switch proposals, changes that agency that have said are needed at once but won't come soon.

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