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Epinephrine metered-dose inhalers are nonmonograph effective June 19 -- FDA final rule.

This article was originally published in The Tan Sheet

Executive Summary

AEROSOL METERED-DOSE BRONCHODILATORS ARE NONMONOGRAPH EFFECTIVE JUNE 19 under a final rule published in the May 20 Federal Register. The rule amends the 1986 final monograph for OTC bronchodilators by removing pressurized metered-dose aerosol dosage forms of epinephrine, epinephrine bitartrate, and racepinephrine hydrochloride. In addition, the rule adds "any ingredient(s) in a pressurized metered dose aerosol container" to the list of nonmonograph active ingredients for the category.

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