The U.S. Food and Drug Administration (FDA) 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 for use in certain over-the-counter (OTC) health care antiseptic products because no additional safety and effectiveness data for these ingredients were provided to the agency. Because, however, these active 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 effectiveness determination about these ingredients. While we await the data on the commonly used ingredients, the FDA recommends health care personnel continue to use the currently available products, consistent with infection control guidelines.
What changes is the FDA finalizing?
This rule finalizes the nonmonograph status of 24 active ingredients (including triclosan) intended 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
- chloroxylenol (PCMX)
Who is most affected by this regulation?
Most health care antiseptics are drug products that are used by health care professionals in a hospital setting or other health care situations outside the hospital. Some health care antiseptics, such as patient antiseptic skin preparations are used on patients for preparation of the skin prior to surgery (i.e., preoperative). Other health care antiseptics are used for preparation of skin prior to an injection (i.e., preinjection) and may also be used by patients outside the traditional health care setting, including for use at home (e.g., by diabetics).
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 and commonly used ingredients, the FDA recommends that health care personnel’s use of the currently available products that include any of these six active ingredients 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.
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.
What if I have questions?
Read additional information at Health Care Antiseptics or contact the FDA directly.
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