Two new bits of Guidance were released today by the FDA in order to get hand sanitizer back in the hands on people that need it the most during our current COVID-19 health emergency. “These guidances provide flexibility to help meet demand during this outbreak,” said FDA Commissioner Stephen M. Hahn, M.D. “We will continue to work with manufacturers, compounders, state boards of pharmacy and the public to increase the supply of alcohol-based hand sanitizer available to Americans.”
Two new “guidance documents” were revealed today. Both of these documents will have rules that’ll remain in effect for the duration of the public health emergency declared by the Secretary of Health and Human Services (HHS) on January 31, 2020. One of these documents provides ingredients and preparation guidance for the preparation of alcohol-based hand sanitizers for consumer use. This first document goes by the name of Guidance for Industry: Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19).
The preparation of the first document was made because of the lack of products available in stores, and because people are, apparently, mixing their own sanitizers at home. Per the FDA: “We are also aware of reports that some consumers are producing hand sanitizers for personal use in their homes; the Agency lacks verifiable information on the methods being used to prepare such products and whether they are safe for use on human skin.”
This first document lists ingredients for hand sanitizer, as outlined by the World Health Organization in an earlier guide. The document says that hand santitizer “is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation)”. It’s important to note, dear readers, that this document is not meant to be released for regular, everyday citizens to start bootlegging their own hand sanitizer at home.
The list in the document is “consistent with” the recommendations of the WHO, re: two documents. One is the 1994 TFM, which they noted “is available at https://www.gpo.gov/fdsys/pkg/FR-1994-06-17/html/94-14503.htm.” The other document shows WHO’s recommendations, titled “Guide to Local Production: WHO-recommended Handrub Formulations,” – that was listed as available at the following URL: who.int/gpsc/5may/Guide_to_Local_Production.pdf. This URL must be copy/pasted because SlashGear does not generally link directly to document files listed online. You may copy and past at your own risk.
The second FDA guidance document was released focusing on “compounding.” This document is called “Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency.” This bit of documentation was made “for the temporary compounding of certain alcohol-based hand sanitizers by pharmacists in state-licensed pharmacies or federal facilities and registered outsourcing facilities.”
Again, none of this guidance was meant for everyday average citizens. It is a sign that the FDA is willing to bend some rules in order for this public health emergency to be dealt with in as efficient a manner as possible. For more information on coronavirus and the quarantine to which we’re all presently subject, stay tuned to the SlashGear main news feed or check out Coronavirus COVID-19 Resources: What should I do? Who do I trust?