The rule was first proposed in 2015, and the FDA notes that since then it has not received additional safety and effectiveness data to support the use of these 24 active ingredients in OTC healthcare antiseptic products.
Products containing the active ingredients are not allowed to be marketed without pre-market review. These products will be considered new drugs requiring new drug applications for marketing. Manufacturers have one year to comply with this rule by reformulating or removing their products from the market.
“Ensuring the safety and effectiveness of over-the-counter health care antiseptics has been a priority for the FDA, not only because these products are an important component of infection control strategies in health care 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, MD, in a statement.
However, this rule does not apply to all healthcare antiseptic ingredients. The FDA has deferred final rulemaking for one year on six specific active ingredients that are most commonly used in OTC antiseptic products currently on the market — alcohol, isopropyl alcohol, povidone-iodine, benzalkonium chloride, benzethonium chloride and chloroxylenol. The FDA is deferring rulemaking for these ingredients to give manufacturers more time to conduct safety and efficacy studies for the ingredients.
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