The U.S. Food and Drug Administration (FDA) has issued a final rule determining that certain active ingredients in over-the-counter topical antiseptics used in health care settings are not considered generally recognized as safe and effective due to insufficient data. As part of the FDA’s ongoing review of topical antiseptic active ingredients used in nonprescription antiseptic drug products, the FDA has issued a final rule determining that triclosan and 23 other active ingredients are not generally recognized as safe and effective used in certain over-the-counter (OTC) health care antiseptic products because no additional safety and effectiveness data for these active ingredients were provided to the agency. Because these ingredients are not used in the majority of currently marketed OTC health care antiseptic products, the agency expects little change to currently available products. The FDA has deferred for one year rulemaking on six active ingredients (benzalkonium chloride, benzethonium chloride, chloroxylenol, ethyl alcohol, isopropyl alcohol, and povidone-iodine) that are the most commonly used in OTC health care antiseptic products to provide manufacturers more time to complete the scientific studies necessary to fill the data gaps identified so that the agency can make a safety and efficacy determination about these ingredients. While we await the data on these commonly used active ingredients, the FDA recommends that health care personnel continue to use currently available products, consistent with infection control guidelines.
What is FDA finaling?
This rule finalizes the nonmonograph status of 24 active ingredients (including triclosan) for use in OTC health care antiseptics because no additional data were submitted to make a safety and efficacy determination for these ingredients. Additionally, based on requests from manufacturers, the final rule reflects the deferral of six active ingredients:
- alcohol (ethanol);
- isopropyl alcohol;
- benzalkonium chloride;
- benzethonium chloride; and
- chloroxylenol (PCMX).
What products are affected?
Of the 24 active ingredients that we have determined are not generally recognized as safe and effective, triclosan is the only active ingredient currently being used in marketed health care antiseptic products today that is affected by this final rule. Therefore, this rule will result in the removal of only a small number of products from the market.
This rulemaking does not apply to health care antiseptics approved under a New Drug Application (e.g., those containing chlorhexidine gluconate); to consumer antiseptics such as antibacterial washes and consumer antiseptic hand rubs and wipes; to food handler antiseptics; or to first aid antiseptics.
Is the FDA concerned that these products are not safe and effective? Should I still use them?
While we await the data on the six deferred active ingredients, the FDA recommends no changes at this time to health care personnel’s use of the currently available products that include any of these six active ingredients, and health care workers should continue to adhere to their work places’ infection control guidelines on this issue. The Joint Commission and the CDC have made recommendations for hand hygiene in the health care setting.
Why is the FDA taking this action?
FDA is responsible for determining whether all drug products, including antiseptics, are safe and effective. Since the FDA began review of health care antiseptics in the 1970s, many things have changed, including the frequency of use of some of these products, hospital infection control practices, new technology that can detect low levels of antiseptics in the body, the FDA’s safety standards and the scientific knowledge about the impact of widespread antiseptic use. As the science-based regulatory agency responsible for determining whether drug products are safe and effective for use by the public, the FDA seeks to ensure that its safety and efficacy evaluations for antiseptic ingredients, including health care antiseptic active ingredients, are consistent, up to date, and appropriately reflect current scientific knowledge and patterns of use by health care professionals.
This final rule is effective December 20, 2018. The monograph or nonmonograph status of the six deferred active ingredients will be addressed, either after completion and analysis of ongoing studies to address the safety and effectiveness data gaps of these ingredients or at a later date, if these studies are not completed.