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The US Food and Drug Administration (FDA) released Thursday a final rule banning the use of certain active ingredients whose safety and efficacy are not demonstrated in hand sanitizers on sale.
Specifically, the Regulations finalize a proposal in 2016 prohibiting the inclusion of 28 active ingredients, including triclosan and benzethonium chloride, in the FDA's list of over-the-counter drugs for use in hand sanitizers consumers, and finalize a final 1994 final monograph for these products.
The FDA has indicated that it has not received any information since the publication of the proposed rule, which could support the inclusion of any of the 28 ingredients in its OTC monograph for disinfectants for hands for consumers.
According to the FDA, the final rule will affect less than 3% of the consumer hand sanitizer market, as most of the hand sanitizers currently marketed use ethyl alcohol as the active ingredient.
Companies wishing to market over-the-counter hand sanitizers containing these ingredients will be required to submit a New Drug Application (NDA) or an Abbreviated New Drug Application (ANDA) for review by the agency.
In the final rule, the FDA also details the types of studies to be conducted to demonstrate that an active ingredient is safe and effective in hand sanitizers intended for consumers.
According to the FDA, the final rule "complements a series of actions" over the past six years to more closely regulate the active ingredients of antiseptic soaps to ensure their safety and effectiveness. The actions follow the steps taken by the FDA in the 1990s to update the monograph published in the 1970s on various topical antiseptics.
In 2017, the FDA finalized another rule banning the use of 24 active ingredients in over-the-counter antiseptic lacquers, rubs and surgical scrubs for hands used in health care facilities.
"Our action today is aimed at giving consumers confidence that the over – the – counter hand sanitizers they use are safe and effective when they are not used. do not have access to water for soap washing, "said Janet, director of the Center for Evaluation and Drug Research. Woodbad said.
For the moment, the FDA postpones the adoption of rules on the use of three other active ingredients, benzalkonium chloride, ethyl alcohol and isopropyl alcohol, in order to give more time in the industry to submit data to support their use.
According to Woodbad, the industry has made great strides in providing this data to the agency.
FDA, final rule
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