Fed Regist. 2016 Sep 6;81(172):61106-30.
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.
美国食品药品监督管理局（FDA、我们或该机构）发布本最终规则，规定用于与水一起使用的非处方（OTC）消费者抗菌产品（在本文中统称为消费者抗菌洗液）中使用的某些活性成分通常不被认为是安全有效的（GRAS/GRAE），并且存在标签错误。FDA在考虑了非处方药咨询委员会（NDAC）的建议、公众对该机构拟议规则制定通知的评论以及该机构所关注的有关OTC消费者抗菌洗液产品的所有数据和信息之后，发布了本最终规则。本最终规则修订了1994年6月17日在《联邦公报》上发布的非处方抗菌药品暂定最终专论（TFM）（1994年TFM）。该最终规则是FDA对OTC药品正在进行的审查的一部分。
