Temporary policy for preparation of certain alcohol-based hand sanitizer products during the public health emergency (COVID-19)
- Collection:
- Health Policy and Services Research
- Series Title(s):
- Guidance for industry
- Contributor(s):
- United States. Department of Health and Human Services. issuing body. United States. Food and Drug Administration. issuing body. Center for Drug Evaluation and Research (U.S.), issuing body.
- Publication:
- [Silver Spring, MD] : Center for Drug Evaluation and Research, February 10, 2021
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Ethanol Hand Sanitizers COVID-19 United States United States. Department of Health and Human Services. United States. Food and Drug Administration.
- Genre(s):
- Technical Report
- Abstract:
- The Food and Drug Administration (FDA or Agency) plays a critical role in protecting the United States from emerging infectious diseases, such as the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support continuity and response efforts to this pandemic. This document updates the guidance of the same title issued in August 2020 (previous versions June, April, and March 2020). FDA is issuing this guidance in response to a number of queries from entities that are not currently licensed or registered drug manufacturers that would like to prepare alcohol-based hand sanitizers, either for public distribution or for their own internal use. The Agency is issuing this guidance to communicate its policy for the temporary preparation of certain alcohol-based2 hand sanitizer products by firms that register their establishment with FDA as an over-the-counter (OTC) drug manufacturer, re-packager, or re-labeler to prepare alcohol-based hand sanitizers under the circumstances described in this guidance ("firms") for the duration of the public health emergency declared by the Secretary of Health and Human Services (HHS) on January 31, 2020, including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service Act (PHS Act) (42 U.S.C. 247d(a)(2)). At such time when the public health emergency is over, as declared by the Secretary, FDA intends to discontinue this enforcement discretion policy and withdraw this guidance. FDA is continually assessing the needs and circumstances related to this temporary policy, and as relevant needs and circumstances evolve, FDA intends to update, modify, or withdraw this policy as appropriate.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (i, 17 pages)).
- NLM Unique ID:
- 9918227352906676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918227352906676