Policy for temporary compounding of certain alcohol-based hand sanitizer products during the public health emergency: immediately in effect guidance for industry
- 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):
- Drug Compounding -- methods 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:
- Due to the Coronavirus Disease 2019 (COVID-19) pandemic, the Food and Drug Administration (FDA or Agency) has received a number of queries concerning compounding of alcohol-based hand sanitizers. This document updates the guidance of the same title issued in August 2020 (previous versions June, April, and March 2020). The Agency is issuing this guidance to communicate its policy for the temporary compounding of certain alcohol-based hand sanitizer products by pharmacists in State- or territory-licensed pharmacies or Federal facilities and registered outsourcing facilities (referred to collectively in this guidance as compounders) 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)). 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 (ii,16 pages)).
- NLM Unique ID:
- 9918227353906676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918227353906676