FDA Consumer Antiseptic Wash Final Rule Questions and Answers Guidance for Industry
标准简介
Consumer Antiseptic Wash Final Rule Questions and Answers Guidance for Industry[附网盘链接]由FDA于不久前发布，适用于US。标准截图
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标准文档类型为Consumer Antiseptic Wash Final Rule Questions and Answers Guidance for Industry[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。标准部分原文
Consumer Antiseptic Wash Final Rule Questions and Answers 1
Guidance for Industry (Small Entity Compliance Guide) This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA office responsible for this guidance as listed on the title page. I. INTRODUCTION This guidance is intended to help small businesses better understand and comply with the final rule establishing that certain active ingredients used in over-the-counter (OTC) consumer antiseptic wash products are not generally recognized as safe and effective (GRASE), and thus, are ineligible for inclusion in the OTC topical antiseptic monograph. On September 6, 2016, FDA published a final rule that finalizes the nonmonograph status of 19 active ingredients, including triclosan and triclocarban, which are intended for use in OTC consumer antiseptic wash products (81 FR 61106) (Consumer Antiseptic Wash Final Rule). Three active ingredients— benzalkonium chloride, benzethonium chloride, and chloroxylenol — were deferred from the final rule to allow more time for sponsors who proposed to complete the studies necessary to fill the safety and effectiveness data gaps identified for these ingredients. These deferrals are for one year, subject to renewal if adequate progress is made in filling the data gaps. The final rule applies to consumer antiseptic wash products that are intended for use with water and are rinsed off after use, including consumer hand washes and consumer body washes. No additional safety or effectiveness data were submitted to support monograph conditions for the 19 consumer antiseptic wash active ingredients. Therefore, with the exception of the three deferred active ingredients, this rule finalizes the nonmonograph status of the remaining 19 active ingredients which are found to be not GRASE for use in consumer antiseptic wash products. Consumer antiseptic wash drug products containing one or more of these non-
GRASE active ingredients will be considered new drugs for which approved new drug applications (NDAs) are required for marketing (21 USC 355(a)). The Consumer Antiseptic Wash Final Rule is effective September 6, 2017. 1
This guidance has been prepared by the Office of Regulatory Policy and Division of Nonprescription Drug Products in the Center for Drug Evaluation and Research at the Food and Drug Administration.
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