New FDA guidance on hand sanitizer production
Alcohol-based hand sanitizer products are in very high demand now, both in the medical space and in the consumer goods space. And, it seems that every business that’s equipped to make sanitizer, from local craft breweries to multinational fragrance companies, is doing so.
Due to the influx of requests to allow for temporary production, the “FDA is issuing this guidance in response to a number of queries from entities that are not currently licensed or registered drug manufacturers that would like to prepare alcohol-based hand sanitizers, either for public distribution or for their own internal use,” explains the introduction to the new guidance for manufacturers.
The FDA is acting fast to address the current Public Health Emergency
“Public Health Emergency” is the agency’s term; and during this time the FDA is working to keep regulations and guidelines for all the industries it covers up to date and applicable. In recent days the FDA has issued guidance for conducting clinical trails during the public health emergency, suspended some grocery store and supply chain regulations that travel limitations have made impractical, expanded the use of remote monitoring of patient vital signs, alerted the public of fraudulent COVID-19 testing kits, and much more.
2 new FDA guidance documents on hand sanitizer production
“We are aware of significant supply disruptions for alcohol-based hand sanitizers,” says FDA Commissioner Stephen M. Hahn, M.D., in a media release about the 2 new FDA guidance documents.
“Many manufacturers make hand sanitizers, and several have indicated that they are working to increase supply,” notes Hahn. “In the meantime,” he says, “these guidances provide flexibility to help meet demand during this outbreak. 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.”
The agency’s new guidance for compounders covers “sanitizer products by pharmacists in State-licensed pharmacies or Federal facilities and registered outsourcing facilities,” according to the FDA. That document can be found online here. And, the new FDA guidance for manufacturers of alcohol-based hand sanitizer can be found here.
As Editor of CosmeticsDesign.com, Deanna Utroske writes daily news about the business of beauty in the Americas region and regularly produces video interviews with cosmetics, fragrance, personal care, and packaging experts as well as with indie brand founders. Find out what Deanna Utroske sees being disrupted in the beauty industry—in both good and challenging ways—by the CoronaVirus in this recent #duviews video.