Policy for testing of alcohol (ethanol) and isopropyl alcohol for methanol, including during the public health emergency (COVID-19)

Policy for testing of alcohol (ethanol) and isopropyl alcohol for methanol, including 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.
Center for Biologics Evaluation and Research (U.S.), issuing body.
Center for Veterinary Medicine (U.S.), issuing body.
Publication:
[Silver Spring, MD] : Center for Drug Evaluation and Research, January 2021
Language(s):
English
Format:
Text
Subject(s):
2-Propanol
Drug Compounding
Ethanol
Methanol
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 guidance is intended to alert pharmaceutical manufacturers and pharmacists in Statelicensed pharmacies or Federal facilities who engage in drug compounding to the potential public health hazard of alcohol (ethyl alcohol or ethanol) or isopropyl alcohol contaminated with or substituted with methanol. FDA is aware of reports of fatal methanol poisoning of consumers who ingested alcohol-based hand sanitizers that were manufactured with methanol or methanol-contaminated ethanol. FDA has also received numerous reports of dermal toxicity associated with such products.
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:
1 online resource (1 PDF file (10 pages)).
NLM Unique ID:
9918250311506676 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/9918250311506676