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FDA Consumer Antiseptic Rub Final Rule Questions and Answers Guidance for Industry

蒋千琴 12/25/2021 浏览 319 FDA 美国

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Consumer Antiseptic Rub Final Rule Questions and Answers Guidance for Industry[附网盘链接]由FDA于过去发布，适用于美国。

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Consumer Antiseptic Rub Final Rule Questions and Answers Guidance for Industry[附网盘链接]
Consumer Antiseptic Rub Final Rule Questions and Answers Guidance for Industry[附网盘链接](截图)

 

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Consumer Antiseptic Rub 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 understand and comply with the Consumer Antiseptic Rub Final Rule; Finding of Ineligibility for Inclusion in Final Monograph (Consumer Antiseptic Rub FR) (84 FR 14847, April 12, 2019), which applies to active ingredients used in over-the-counter (OTC) consumer antiseptic rub products that are sometimes referred to as rubs, leave-on products, or hand sanitizers. The Consumer Antiseptic Rub FR also applies to active ingredients used in OTC consumer antiseptic wipes. The Consumer Antiseptic Rub FR established that 28 active ingredients used in nonprescription consumer antiseptic rub products are not eligible for evaluation under FDA’s ongoing rulemaking to evaluate the safety and effectiveness of OTC drug products marketed in the United States on or before May 1972, which is known as the OTC Drug Review. Drug products containing these active ingredients will require approval under a new drug application (NDA) or an abbreviated new drug application (ANDA) before they can be marketed. The Consumer Antiseptic Rub FR also established that three active ingredients used in consumer antiseptic rub products—benzalkonium chloride, ethyl alcohol, and isopropyl alcohol—are 2

eligible for evaluation under the OTC Drug Review. In response to several requests submitted to the 2016 Consumer Antiseptic Rub Proposed Rule (Consumer Antiseptic Rub PR) (81 FR 42912, June 30, 2016), FDA temporarily deferred further rulemaking on making a generally recognized as safe and effective (GRAS/GRAE) determination for these three eligible active 1

This guidance has been prepared by the Office of Regulatory Policy and the Division of Nonprescription Drug Products in the Center for Drug Evaluation and Research at the Food and Drug Administration. 2

On March 27, 2020, the Over-the-Counter Monograph Safety, Innovation, and Reform Act (OMSIRA) was signed into law as part of the newly enacted Coronavirus Aid, Relief, and Economic Security Act (CARES Act) (Public Law No. 116-136, 134 Stat. 281 (March 27, 2020)). OMSIRA is intended to modernize the process by which FDA regulates over-the-counter monograph drugs. FDA is in the process of implementing the changes set forth in OMSIRA, however, OMSIRA does not revise the findings in the Consumer Antiseptic Rub FR.

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