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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

As those of us of a certain age remember, prior to 2005/2006, pseudoephedrine was the decongestant of choice for OTC multi-symptom cold medicine. Then, Congress passed, and the President signed the Combat Methamphetamine Epidemic Act of 2005. a); OTC Monograph M012: § M012.20. a); OTC Monograph M012: § M012.20.