The FDA finalized a rule(s3.amazonaws.com) Dec. 20 that it first proposed in 2015, finding that triclosan and 23 other active ingredients aren't generally recognized as safe and effective (GRASE) for use in OTC health care antiseptic products. These include health care personnel hand washes and rubs, surgical hand scrubs and rubs, and patient antiseptic skin preparations.
No other safety and effectiveness data were provided to the FDA to support monograph conditions for these 24 active ingredients.
This means that products containing these active ingredients that are intended for use in OTC health care antiseptics by health care professionals -- in a hospital setting or other health care situations -- may no longer be marketed without undergoing premarket review.
Of the 24 active ingredients that the FDA found to be non-GRASE, triclosan is the only one currently being used in any marketed health care antiseptic products, the FDA said, so most currently marketed health care antiseptics will not be impacted by this final rule.
"Ensuring the safety and effectiveness of OTC 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, M.D., in a news release. (www.fda.gov)
"Health care providers are on the front lines of care. They need and deserve to have safe and effective means for preventing the spread of infection. That's why the FDA has been vigilant in seeking the data to support the continued use of 30 active ingredients used in OTC health care antiseptics."
Gottlieb said the FDA's decision was based on a lack of sufficient safety and efficacy data supporting use of these ingredients.
"However, it's important to note that this action does not impact all health care antiseptic ingredients," he said. "Rather, 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."
In response to industry requests, the FDA has deferred final rulemaking for one year, subject to renewal, on these six active ingredients that are the most commonly used in currently marketed OTC health care antiseptic products:
- alcohol (ethanol),
- isopropyl alcohol,
- benzalkonium chloride,
- benzethonium chloride, and
- chloroxylenol (PCMX).
The FDA said this move is intended to provide manufacturers more time to complete the scientific studies necessary to fill data gaps and allow the agency to make a determination about the safety and efficacy of these ingredients.
"Importantly, this doesn't mean that products containing these six ingredients are ineffective or unsafe," Gottlieb said in the release. "These antiseptic products remain an important resource in health care settings. Personnel should continue to use these products consistent with infection control guidelines while the additional data are gathered."
Additionally, the final rule doesn't affect health care antiseptics that are currently marketed under new drug applications and abbreviated new drug applications.
Health care antiseptic drug products containing one or more of the non-GRASE active ingredients will be considered new drugs for which marketing will require approved new drug applications.
Manufacturers will have one year to comply with this final rule by reformulating these products or removing them from the market. Based on the proposed rule, the FDA said manufacturers have already started removing these ingredients from their products.
This final rule is part of the FDA's continued comprehensive review of OTC antiseptic active ingredients to ensure safety and efficacy. The agency previously issued final rulemaking on consumer antiseptic washes(www.federalregister.gov) in September 2016 and a proposed rule on consumer antiseptic rubs(www.fda.gov) in June 2016.
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