By Brian Craig, J.D.
The FDA has issued a Final rule on over-the-counter (OTC) antiseptics used in health care based on new data that suggests systemic exposure to active ingredients is higher than previously thought. The Final rule, which is effective on December 20, 2018, applies only to OTC health care antiseptics that are intended for use by health care professionals and does not cover consumer antiseptics. The rule applies to 24 antiseptic active ingredients. The FDA has deferred further rulemaking on six active ingredients commonly used in OTC health care antiseptic products, including benzethonium chloride and alcohol (Final rule, 82 FR 60474, December 20, 2017).
New drugs. The 24 antiseptic active ingredients under the rule are used in patient antiseptic skin preparation, health care personnel hand wash, health care personnel hand rub, surgical hand scrub, and surgical hand rub. The OTC health care antiseptic drug products containing the active ingredients will require approval under a new drug application (NDA) or an abbreviated new drug application (ANDA) prior to marketing. The FDA has deferred further rulemaking on six active ingredients used in OTC health care antiseptic products to allow for the development and submission to the record of new safety and effectiveness data for these ingredients. These active ingredients include benzalkonium chloride, benzethonium chloride, chloroxylenol, alcohol (also referred to as ethanol or ethyl alcohol), isopropyl alcohol, and povidone-iodine. Benzethonium chloride is an active ingredient commonly used as a health care personnel hand rub or a surgical hand rub.
Scope. The Final rule covers only OTC health care antiseptics that are intended for use by health care professionals in a hospital setting or other health care situations outside the hospital. This final rule does not cover consumer antiseptic washes, consumer antiseptic rubs, antiseptics identified as "first aid antiseptics," or antiseptics used by the food industry.
Risk. OTC health care antiseptic active ingredients have occurred since the FDA’s 1994 safety evaluation. Improved analytical methods now exist that can detect and more accurately measure these active ingredients at lower levels in the bloodstream and tissue. Consequently, new data suggest that the systemic exposure to these active ingredients is higher than previously thought, and new information about the potential risks from systemic absorption and long-term exposure is now available. New safety information also suggests that widespread antiseptic use could have an impact on the development of bacterial resistance. To support a classification of generally recognized as safe (GRAS) for health care antiseptic active ingredients, the FDA proposed that additional data were needed to demonstrate that those ingredients meet current safety standards. Data also suggests pregnant women, children, and the elderly may be particularly sensitive to exposure.
Proposed rule. In response to the 2015 Health Care Antiseptic Proposed Rule (80 FR 25166), the FDA received approximately 29 comments from drug manufacturers, trade associations, academia, testing laboratories, health professionals, and individuals. The FDA also received additional data and information for certain deferred health care antiseptic active ingredients. The FDA responded to these comments in the Final rule (see FDA proposes getting the bugs out of its over-the-counter antiseptic standards, May 1, 2015).
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