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FDA’s Proposal to Remove Oral Phenylephrine from the OTC Monograph Isn’t a Surprise but What is Left “Over-the-Counter”?

FDA Law Blog: Biosimilars

Comments on the proposed order are due May 25, 2025. Whether those products will be reformulated to include pseudoephedrine and then held behind-the-counter is unknown but seems unlikely as well as unwelcome from the standpoint of pharmacy management. That means almost certainly no sooner than the second half of 2026.