Ingredient officially not OTC
This article was originally published in The Tan Sheet
Executive SummaryFDA removes carbetapentane citrate from its regulation that exempts some drugs from being limited to prescription sale, according to a Nov. 30 Federal Register notice. Although carbetapentane citrate is no longer used in U.S. OTC products, FDA says it made the change because the ingredient has not been shown to be effective at the OTC doses stated in the exempting regulation. The agency says the amendment is technical because carbetapentane citrate should have been removed from the prescription-only exempting regulation when the ingredient was classified as not generally recognized as safe and effective in FDA's 1987 antitussive OTC monograph...
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