{"id":"AGY-FED-HEALTH-OTHER-041","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), 502(f)(1), 505, 582; enforcement discretion","instrument":"Guidance for Industry: Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) (Mar. 19, 2020; updated Mar. 27 and Apr. 15, 2020, and later)","title":"Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19)","dateIssued":"2020-03-19","effective":"2020-03-19 (immediately in effect)","end":"2021-12-31 (FDA withdrawal announced Oct. 12, 2021; products made under the policy to be sold out by Mar. 31, 2022)","startDate":"2020-03-19","endDate":"2021-12-31","quarters":["2020Q2","2020Q3","2020Q4","2021Q1","2021Q2","2021Q3"],"types":["SUPPLY","OTHER"],"addressees":["firms preparing hand sanitizer (pharmacies, compounders, distillers, manufacturers)"],"clause":"Because of the public health emergency posed by COVID-19, FDA does not intend to take action against firms that prepare 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, provided the following circumstances are present","enforcement":"Enforcement discretion under 21 U.S.C. 331 for violations of the listed sections","functions":["PF production floor (converted lines)","SC supply chain","RT retail products"],"notes":"Reached distilleries, breweries, cosmetics and chemical manufacturers that converted production; a compelled-substitute predicate for employers\u0027 sanitation supply under State orders.","sourceUrl":"https://www.fda.gov/media/136289/download","snapshot":"https://web.archive.org/web/20200320212601/https://www.fda.gov/media/136289/download","fileExists":true,"fileBytes":173144,"grade":"primary","character":"context","description":"","collection":"AGY-FED-HEALTH-OTHER","url":"/library/AGY-FED-HEALTH-OTHER-041","exhibitUrl":"/exhibit/AGY-FED-HEALTH-OTHER-041","citation":"Food and Drug Administration, CDER, Guidance for Industry: Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) (Mar. 19, 2020; updated Mar. 27 and Apr. 15, 2020, and later) (Ex. AGY-FED-HEALTH-OTHER-041)","stateName":"","related":["AGY-FED-HEALTH-OTHER-042"]}