Pseudoephedrine Will Be Behind The Counter Across The Country By October
This article was originally published in The Tan Sheet
Retailers will have to be prepared to enforce monthly gram purchase limits on pseudoephedrine products by mid-April, once meth control provisions of the Patriot Act reauthorization bill go into effect
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Phenylephrine doesn’t meet efficacy bar within “generally regarded as safe and effective” standard for OTC monograph drugs, agency says in briefing prepared for NDAC meeting on 11-12 September. FDA say it is “concerned about avoiding potential unintended consequences with regard to changing the GRASE status of oral PE.”
Nonprescription Drugs Advisory Committee will meet online 11-12 September to consider data regarding generally recognized as safe and effective status for oral phenylephrine as a nasal decongestant which have become available since FDA last examined ingredient.
Change noted without elaboration in update to FDA announcement on Nonprescription Drugs Advisory Committee meeting. CHPA also notes change, saying it’s best for Industry and for consumers.