United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2016_register executive 2018-02-09 article Rules and Regulations D09002ee1c7f4314c D09002ee1c7f431bc United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA, we, or the Agency) is issuing this final rule establishing that certain active ingredients used in over-the-counter (OTC) consumer antiseptic products intended for use with water (referred to throughout this document as consumer antiseptic washes) are not generally recognized as safe and effective (GRAS/GRAE) and are misbranded. 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 consumer antiseptic wash products that have come to the Agency's attention. This final rule amends the 1994 tentative final monograph (TFM) for OTC antiseptic drug products that published in the Federal Register of June 17, 1994 (the 1994 TFM). The final rule is part of the ongoing review of OTC drug products conducted by FDA. 81 FR 61106 https://www.govinfo.gov/app/details/FR-2016-09-06/2016-21337 2016-21337 fr06se16-5 RIN 0910-AF69 4164-01-P Docket No. FDA-1975-N-0012 Formerly Part of Docket No. 1975N-0183H https://www.govinfo.gov/app/details/FR-2016-09-06/2016-21337 https://www.govinfo.gov/content/pkg/FR-2016-09-06/html/2016-21337.htm https://www.govinfo.gov/content/pkg/FR-2016-09-06/pdf/2016-21337.pdf Administrative Practice and Procedure Drugs Labeling Medical Devices Reporting and Recordkeeping Requirements 25 p. 61106 61130 81 FR 61106 Title 21 Part 310 21 CFR Part 310 RIN 0910-AF69 Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Federal Register Vol. 81, Issue RULE 2016-21337 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2017-09-06 Docket No. FDA-1975-N-0012 Formerly Part of Docket No. 1975N-0183H 4164-01-P 2016-21337 Final rule.

The Food and Drug Administration (FDA, we, or the Agency) is issuing this final rule establishing that certain active ingredients used in over-the-counter (OTC) consumer antiseptic products intended for use with water (referred to throughout this document as consumer antiseptic washes) are not generally recognized as safe and effective (GRAS/GRAE) and are misbranded. 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 consumer antiseptic wash products that have come to the Agency's attention. This final rule amends the 1994 tentative final monograph (TFM) for OTC antiseptic drug products that published in the Federal Register of June 17, 1994 (the 1994 TFM). The final rule is part of the ongoing review of OTC drug products conducted by FDA.

This rule is effective September 6, 2017. Pranvera Ikonomi, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 5418, Silver Spring, MD 20993-0002, 240- 402-0272. 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of the Federal Register, National Archives and Records Administration 2016-09-06 continuing daily deposited born digital 492 p. 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