Under the rule, which was first proposed in 2015, manufacturers will have one year to remove the active ingredients, take the product off the market or file a new drug application.
The FDA determined the 24 banned ingredients are no longer appropriate for over-the-counter use since they are not recognized as safe and effective.
“Ensuring the safety and effectiveness of over-the-counter healthcare antiseptics has been a priority for the FDA, not only because these products are an important component of infection control strategies in healthcare settings, but also because of the role these products may play in contributing to antimicrobial resistance if they’re not manufactured or used appropriately,” said FDA Commissioner Scott Gottlieb, according to RAPS.
At this time the FDA is deferring its decision on six of the most commonly used antiseptic ingredients — ethanol, isopropyl alcohol, povidone-iodine, benzalkonium chloride, benzethonium chloride, and chloroxylenol — while manufacturers test the safety and efficacy of those ingredients.
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