Jump to content
EZdrinking

FDA Temporary Policy for Compounding Sanitizer

Recommended Posts

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

Share this post


Link to post
Share on other sites

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

Share this post


Link to post
Share on other sites

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 ?

Share this post


Link to post
Share on other sites

Create an account or sign in to comment

You need to be a member in order to leave a comment

Create an account

Sign up for a new account in our community. It's easy!

Register a new account

Sign in

Already have an account? Sign in here.

Sign In Now

×
×
  • Create New...