{"abstract":"The Food and Drug Administration (FDA, the Agency, or we) is issuing this final rule establishing that certain active ingredients used in nonprescription (also known as over-the-counter or OTC) antiseptic products intended for use by health care professionals in a hospital setting or other health care situations outside the hospital are not generally recognized as safe and effective (GRAS/GRAE). FDA is issuing this final rule after considering the recommendations of the Nonprescription Drugs Advisory Committee (NDAC); public comments on the Agency's notices of proposed rulemaking; and all data and information on OTC health care antiseptic products that have come to the Agency's attention. This final rule finalizes the 1994 tentative final monograph (TFM) for OTC health care antiseptic drug products that published in the Federal Register of June 17, 1994 (the 1994 TFM) as amended by the proposed rule published in the Federal Register (FR) of May 1, 2015 (2015 Health Care Antiseptic Proposed Rule (PR)).","action":"Final rule.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2017/12/20/2017-27317.html","cfr_references":[{"chapter":null,"citation_url":null,"part":310,"title":21}],"citation":"82 FR 60474","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective December 20, 2018.","disposition_notes":null,"docket_ids":["Docket No. FDA-2015-N-0101"],"dockets":[],"document_number":"2017-27317","effective_on":"2018-12-20","end_page":60503,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2017/12/20/2017-27317.xml","html_url":"https://www.federalregister.gov/documents/2017/12/20/2017-27317/safety-and-effectiveness-of-health-care-antiseptics-topical-antimicrobial-drug-products-for","images":{"ER20DE17.001":{"large":"https://img.federalregister.gov/ER20DE17.001/ER20DE17.001_large.png","original_size":"https://img.federalregister.gov/ER20DE17.001/ER20DE17.001_original_size.png"},"ER20DE17.000":{"large":"https://img.federalregister.gov/ER20DE17.000/ER20DE17.000_large.png","original_size":"https://img.federalregister.gov/ER20DE17.000/ER20DE17.000_original_size.png"}},"images_metadata":{"ER20DE17.001":{"large":{"identifier":"ER20DE17.001","content_type":"image/png","size":60060,"width":823,"sha":"2ad206362b2123a77e4c4cb9f41d7856","url":"https://img.federalregister.gov/ER20DE17.001/ER20DE17.001_large.png","height":731},"original_size":{"identifier":"ER20DE17.001","content_type":"image/png","size":144205,"width":3855,"sha":"e43750d46343743db219f5addffac16a","url":"https://img.federalregister.gov/ER20DE17.001/ER20DE17.001_original_size.png","height":3425}},"ER20DE17.000":{"large":{"identifier":"ER20DE17.000","content_type":"image/png","size":66814,"width":823,"sha":"3169dbfde4ab5eba0387955dbac73305","url":"https://img.federalregister.gov/ER20DE17.000/ER20DE17.000_large.png","height":715},"original_size":{"identifier":"ER20DE17.000","content_type":"image/png","size":137296,"width":3870,"sha":"652fa91a5b86812ab10071cb66d39b45","url":"https://img.federalregister.gov/ER20DE17.000/ER20DE17.000_original_size.png","height":3360}}},"json_url":"https://www.federalregister.gov/api/v1/documents/2017-27317?publication_date=2017-12-20","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2017-12-20/2017-27317/mods.xml","not_received_for_publication":null,"page_length":30,"page_views":{"count":54098,"last_updated":"2026-04-04 12:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2017-12-20/pdf/2017-27317.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2017-27317.pdf?1513691133","publication_date":"2017-12-20","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2017/12/20/2017-27317.txt","regulation_id_number_info":{"0910-AH40":{"issue":"201710","html_url":"https://www.federalregister.gov/regulations/0910-AH40/safety-and-effectiveness-of-healthcare-antiseptics-topical-antimicrobial-drug-products-for-over-the-","title":"Safety and Effectiveness of Healthcare Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use ","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201710&RIN=0910-AH40&operation=OPERATION_EXPORT_XML","priority_category":"Other Significant"}},"regulation_id_numbers":["0910-AH40"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Response Letter from FDA CDER to American Cleaning Institute","document_id":"FDA-2015-N-0101-1315"},{"title":"Reference 143 - Heller & Burd, Review of Ethanol Dispersion Distribution and Elimination from the Fetal Compartment re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record","document_id":"FDA-2015-N-0101-1051"},{"title":"Reference 39-59 - FDA-1975-N-0012-0227 --- CP7 Tab_12_Appendix_D_Chlorhexidine_Gluconate_Healthcare_Personnel_Handwash_Studies_Tables_1_Thru_9 re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record","document_id":"FDA-2015-N-0101-0903"},{"title":"Reference 39-62 - FDA-1975-N-0012-0227 --- CP7Tab_5_Section_3_The_Relationship_of_Benefit_to_Efficacy_Tables_1_Thru_3 re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record","document_id":"FDA-2015-N-0101-0868"},{"title":"Reference 12-86 - FDA-1975-N-0012-0170 --- PR8 13 Week Dermal Toxicity Study inMice re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record","document_id":"FDA-2015-N-0101-0647"},{"title":"Reference 12-78 - FDA-1975-N-0012-0159 --- C58 re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record","document_id":"FDA-2015-N-0101-0639"},{"title":"Reference 12-76 - FDA-1975-N-0012-0151 --- C52 re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record","document_id":"FDA-2015-N-0101-0637"},{"title":"Reference 12-71 - FDA-1975-N-0012-0143 --- LET13 re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record","document_id":"FDA-2015-N-0101-0632"},{"title":"Reference 12-68 - FDA-1975-N-0012-0139 --- MM4 FDA_CDER_and_NIPA_Hardwicke_Inc_September_22_1997_Memorandum_of_Meeting re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record","document_id":"FDA-2015-N-0101-0629"},{"title":"Reference 12-7 - FDA-1975-N-0012-0062 --- C4 Domani_Laboratories_Comment re Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record","document_id":"FDA-2015-N-0101-0568"}],"regulatory_plan":{"html_url":"https://www.federalregister.gov/regulations/0910-AF69/over-the-counter-otc-drug-review-topical-antimicrobial-drug-products","title":"Over-the-Counter (OTC) Drug Review--Topical Antimicrobial Drug Products"},"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2015-N-0101","supporting_documents_count":1353,"docket_id":"FDA-2015-N-0101","regulation_id_number":"0910-AF69","title":"Safety and Effectiveness for Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use","checked_regulationsdotgov_at":"2018-01-09T06:00:22Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":60474,"subtype":null,"title":"Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use","toc_doc":"Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use","toc_subject":null,"topics":["Administrative practice and procedure","Drugs","Labeling","Medical devices","Reporting and recordkeeping requirements"],"type":"Rule","volume":82}