EZdrinking Posted March 27, 2020 Share Posted March 27, 2020 FDA is issuing this guidance for immediate implementation in accordance with 21 CFR 10.115(g)(2). Comments may be submitted at any time for Agency consideration. Submit written comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit electronic comments to https://www.regulations.gov. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register. For questions regarding this document, contact FDA’s human drug compounding team (CDER) at compounding@fda.hhs.gov. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) March 2020 https://www.fda.gov/media/136118/download Hand-Sanitizers-Immediately-in-Effect-Guidance-3-20-2020-345pm.pdf Link to comment Share on other sites More sharing options...
EZdrinking Posted March 27, 2020 Author Share Posted March 27, 2020 Updated FDA Guidence 3/24/20 This guidance is being issued to address the Coronavirus Disease 2019 (COVID-19) public health emergency. This is being implemented without prior public comment because FDA has determined that prior public participation for this guidance is not feasible or appropriate (see section 701(h)(1)(C)(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR 10.115(g)(2)). This guidance document is being implemented immediately, but it remains subject to comment in accordance with the Agency’s good guidance practices. Download full doc below. Ethanol-for-Hand-Sanitizer-FINAL-3.24.20.pdf Link to comment Share on other sites More sharing options...
KRS Posted April 2, 2020 Share Posted April 2, 2020 Allelujah! I was considering defiant action, but reason prevails on both sides! Additionally, although the possibility of illicit use by those in desperate need of an alcoholic beverage, the issue of children accidentally ingesting it made me cough. I used to work in a profession where contact with the Poison Control Center was on speed dial. Since children have been known to wilfully ingest Drano, what could we possibly do to ethyl alcohol to top that for an unpleasant taste deterrent ? Link to comment Share on other sites More sharing options...
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