Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                Information by Drug Class

Information by Drug Class

                        Prescription Stimulant Medications


                        Human Immunodeficiency Virus (HIV) Home
          Drugs
          Drug Safety and Availability
          Information by Drug Class
          Q&A for Health Care Professionals: Health Care AntisepticsInformation by Drug Class Q&A for Health Care Professionals: Health Care Antiseptics
  
  	
    Share
    Post
    Linkedin

    Email
    PrintQ&As for Health Care Professionals: Health Care Antiseptics12/19/2017*The U.S. Food and Drug Administration (FDA) has issued a final ruledetermining 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;povidone-iodine;benzalkonium chloride;benzethonium chloride; andchloroxylenol (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.What’s nextThis 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.**Questions?**Read additional information at Health Care Antiseptics or contact the FDA directlyToll Free (855) 543-3784, or (301) 796-3400, druginfo@fda.hhs.govRelated InformationHealth Care Antiseptics

                                                                                  Content current as of:
      12/19/2017Information by Drug Class

          
                        Prescription Stimulant Medications


                        Human Immunodeficiency Virus (HIV)
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop