{"id":"AGY-FED-HEALTH-OTHER-042","kind":"context","level":"federal","jurisdiction":"United States (federal); Food and Drug Administration, Center for Drug Evaluation and Research","state":"","metro":"","industry":"","agency":"FED-HEALTH-OTHER","eco":"","issuer":"Food and Drug Administration, CDER","authority":"FD\u0026C Act ss. 501(a)(2)(B), 501(b), 502(f)(1), 505, 582; enforcement discretion","instrument":"Guidance for Industry: Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) (Mar. 24, 2020; updated Mar. 27 and Apr. 15, 2020, and later)","title":"Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19)","dateIssued":"2020-03-24","effective":"2020-03-24 (immediately in effect)","end":"2021-12-31","startDate":"2020-03-24","endDate":"2021-12-31","quarters":["2020Q2","2020Q3","2020Q4","2021Q1","2021Q2","2021Q3"],"types":["SUPPLY","OTHER"],"addressees":["alcohol production firms (distillers, fuel-ethanol producers)"],"clause":"Because of the public health emergency posed by COVID-19, FDA does not intend to take action against alcohol production firms that manufacture alcohol (i.e., ethanol or ethyl alcohol) for use as the Active Pharmaceutical Ingredient (API) in alcohol-based hand sanitizers for consumer use and for use as health care personnel hand rubs for the duration of the public health emergency declared by the Secretary of HHS on January 31, 2020","enforcement":"Enforcement discretion under 21 U.S.C. 331","functions":["PF production floor","SC supply chain"],"notes":"","sourceUrl":"https://www.fda.gov/media/136390/download","snapshot":"https://web.archive.org/web/20200413183121/https://www.fda.gov/media/136390/download","fileExists":true,"fileBytes":188037,"grade":"primary","character":"context","description":"","collection":"AGY-FED-HEALTH-OTHER","url":"/library/AGY-FED-HEALTH-OTHER-042","exhibitUrl":"/exhibit/AGY-FED-HEALTH-OTHER-042","citation":"Food and Drug Administration, CDER, Guidance for Industry: Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) (Mar. 24, 2020; updated Mar. 27 and Apr. 15, 2020, and later) (Ex. AGY-FED-HEALTH-OTHER-042)","stateName":"","related":["AGY-FED-HEALTH-OTHER-041"]}