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Regulatory News | 19 December 2017 | By Michael Mezher
The US Food and Drug Administration (FDA) on Tuesday finalized a rule barring the use of 24 active ingredients, including triclosan, from use in over-the-counter (OTC) antiseptic washes and rubs such as hand washes and surgical hand scrubs used in health care settings.
The rule was first proposed in 2015, and finalizes a 1994 tentative final monograph for OTC antiseptics as amended by the 2015 proposed rule.
"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.
FDA says it has determined that the 24 ingredients subject to the final rule are not generally recognized as safe and effective (GRASE) and are no longer appropriate for OTC use. The agency also notes that the final rule does not apply to consumer antiseptic washes or rubs, first aid antiseptics or antiseptics used in the food industry.
Under the final rule, manufacturers will have one year to remove the 24 ingredients from their products. Of the 24, FDA says triclosan is the only one currently marketed and that going forward manufacturers will need to submit a new drug application (NDA) before marketing antiseptics containing any of the other ingredients.
FDA also said it is deferring a rulemaking on six of the most commonly used antiseptic ingredients—alcohol (ethanol), isopropyl alcohol, povidone-iodine, benzalkonium chloride, benzethonium chloride, and chloroxylenol (PCMX)—to give manufacturers more time to gather data on their use.
"Given the public health importance of these products, the FDA is deferring final rulemaking on the six most commonly used ingredients while manufacturers collect the data needed to properly weigh their safety and efficacy," Gottlieb said, noting that manufacturers have known for two years that the agency wanted additional information on antiseptic ingredients.
The move also comes more than a year after the agency issued a final rule restricting 19 antiseptic ingredients from use in consumer antiseptic washes. FDA also issued a guidance earlier this year to assist small businesses in complying with the 2016 final rule.
The agency issued a separate proposed rule requesting additional information from manufacturers on consumer antiseptic rubs in June 2016.
Federal Register Notice, FDA
Tags: Antiseptics, OTC, Final Rule, Triclosan