翻译： JULIA 来源：Julia法规翻译
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FDA宣布全面禁售抗菌皂，舒肤佳、滴露、蓝月亮、贝亲等都在列
31.08.2017
FDA Final Rule for Antiseptic Soaps
FDA抗菌皂规定定稿
InDecember 2013, the FDA issued a proposed rule to amend the 1994 tentative finalmonograph or proposed rule (the 1994 TFM) for over-the-counter (OTC) antisepticdrug products. It was proposed to establish conditions under which OTC consumerantiseptic products intended for use with water (generally referred to as consumerantiseptic washes) are generally recognized as safe and effective. Due to theongoing scientific developments the FDA considered that new safety data shouldbe evaluated for some products which were evaluated in 1994 as save for the useby consumers. Then, in 2016, the FDA issued a final rule on "Safety and Effectiveness of Consumer Antiseptics;Topical Antimicrobial Drug Products for Over-the-Counter Human Use" .They summarized:
在2013年12月，FDA曾发布一份拟定规定，对1994年OTC抗菌皂临时最终版各论或所似规定（1994年TFM）进行修订。当时提议制订与水一起使用抗菌产品的OTC消费者的通常认可为安全有效的条件（通常称为消费者无菌洗用品）。由于科学持续发展，FDA考虑到要评估一些曾经在1994年已评估认为患者使用安全的产品的新安全数据。因此，2016年，FDA签发了其“OTC人用消费者抗菌、局部抗微生物药品安全性和有效性”最终指南。他们总结如下：
"TheFood and Drug Administration (FDA, we, or the Agency) is issuing this finalrule establishing that certain active ingredients used in over-the-counter(OTC) consumer antiseptic products intended for use with water (referred tothroughout this document as consumer antiseptic washes) are not generallyrecognized as safe and effective (GRAS/GRAE) and are misbranded. FDA is issuingthis final rule after considering the recommendations of the NonprescriptionDrugs Advisory Committee (NDAC); public comments on the Agency's notices ofproposed rulemaking; and all data and information on OTC consumer antisepticwash products that have come to the Agency's attention. This final rule amendsthe 1994 tentative final monograph (TFM) for OTC antiseptic drug products thatpublished in the Federal Register of June 17, 1994 (the 1994 TFM). The finalrule is part of the ongoing review of OTC drug products conducted by FDA."
“FDA签发此规定终稿意在定义哪些与水共用OTC消费者抗菌药品中的特定活性成分（在本文件中称为消费用抗菌洗用品）被认为不是安全有效的（GRAS/GRAE），如有将作为冒牌产品处理。FDA是在考虑提交给FDA的非处方药品建议委员会（NDAC）的建议、公众对FDA所拟规定通知的建议、所有OTC消费用抗菌洗用品的数据和信息后签发此最终规定的。此最终规定修订了1994年6月17日发布在邦联公报上对OTC抗菌药品的临时最终各论（EFM）。最终规定是FDA对OTC药品持续审核的一部分。
Now,in July 2017, the authority published an additional "Guidance for Industry Consumer Antiseptic WashFinal Rule - Questions and Answers" . This new document is supposed togive guidance to small businesses for a better understanding and for complyingwith the final rule from 2016. This final rule and the additions are part ofFDA's ongoing rulemaking to evaluate the safety and effectiveness of OTC drugproducts marketed in the United States on or before May 1972 (OTC Drug Review).Nineteen ingredients were subject of the final rule: cloflucarban, fluorosalan,hexachlorophene, hexylresorcinol, Iodophors (Iodine-containing ingredients),iodine complex (ammonium ether sulfate and polyoxyethylene sorbitanmonolaurate), Iodine complex (phosphate ester of alkylaryloxy polyethyleneglycol), nonylphenoxypoly (ethyleneoxy) ethanoliodine, poloxamer-iodinecomplex, povidone-iodine, undecoylium chloride iodine complex,methylbenzethonium chloride, phenol4, secondary amyltricresols, sodiumoxychlorosene, tribromsalan, triclocarban, triclosan and triple dye. This willaffect up to 2100 products in the hand and body wash market.
2017年7月，FDA发布了另一份“行业指南—消费用抗菌洗用品最终规定—问答”。此新文件意在为小规模企业提供指南，更好理解和符合2016年以来的最终规定。该最终规定和增加部分是FDA持续管理评估1972年5月之前在美国上市的OTC药品安全性和有效性的一部分（OTC药品审核）。最终规定里有19种成分：卤卡班（Cloflucarban）、氟沙仑（Fluorosalan）、仲烷基甲基苯酚（Secondaryamyltricresols）、六氯酚（Hexachlorophene）、间苯二酚（Hexylresorcinol）、碘复合物（Iodinecomplex）：（铵醚硫酸盐、聚氧乙烯脱水山梨醇单月桂酸酯ammoniumether sulfate and polyoxyethylene sorbitan monolaurate）、碘复合物（Iodinecomplex）：烷基芳氧基聚乙二醇磷酸酯、壬基苯酚聚氧乙烯醚-碘复合物（Nonylphenoxypoly(ethyleneoxy)ethanoliodine）、泊洛沙姆- 碘配合（Poloxamer-iodinecomplex）、碘伏（Povidone-iodine）5％到10％、恩地氯铵碘（Undecoyliumchloride iodine complex）、氯化苄乙氧铵（Methylbenzethoniumchloride）、苯酚（Phenol，大于1.5％）、苯酚（Phenol小于1.5％）、氧氯苯磺酸钠（Sodiumoxychlorosene）、三溴沙仑（Tribromsalan）、三氯卡班（Triclocarban）、三氯生（Triclosan）、三重染料（Tripledye）。这将影响到2100多种在售洗手和洗浴产品。
