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Law360 (March 20, 2020, 3:35 PM EDT ) The U.S. Food and Drug Administration on Friday took steps to boost the production of alcohol-based hand sanitizers, which have flown off store shelves during the coronavirus outbreak.
The FDA said that while the outbreak lasts, it won't be taking action against companies that make hand sanitizers, as long as ethanol or isopropyl alcohol is used in the correct amount and the product is made under sanitary conditions and is properly labeled. The FDA said that it had heard requests for guidance from companies that aren't currently regulated drug manufacturers about making sanitizers in response to their demand.
"We are aware of significant supply disruptions for alcohol-based hand sanitizers. Many manufacturers make hand sanitizers, and several have indicated that they are working to increase supply," FDA Commissioner Stephen M. Hahn said in a statement. "In the meantime, these guidances provide flexibility to help meet demand during this outbreak."
Companies will also have to register with the FDA and will receive automatic confirmation once the registration is complete, according to the guidance.
The FDA cautioned that companies need to use ingredients consistent with World Health Organization recommendations — alcohol, glycerol, hydrogen peroxide and sterile water — and not make substitutions.
Washing hands often with soap and water for at least 20 seconds is essential to combating the spread of the novel coronavirus, but if soap and water are not readily available, the Centers for Disease Control and Prevention has said a hand sanitizer that contains at least 60% alcohol can act as a substitute, the FDA said.
The World Health Organization last week declared COVID-19 a pandemic — a disease that has spread across the world.
According to the Johns Hopkins University Coronavirus Resource Center, which is tracking the pandemic, there have been 209,839 confirmed COVID-19 cases and 8,778 deaths worldwide as of Friday afternoon. There are 10,442 cases in the U.S. and 150 deaths nationwide.
The FDA also said that it won't take action against pharmacy compounders who make hand sanitizers during the pandemic, as long as they follow the same protocols outlined for manufacturers.
"The agency realizes that manufacturers and compounders will need time to ramp up production as they obtain the ingredients needed to make these hand sanitizers," the FDA said. "During this time the FDA will work to assist them as they develop hand sanitizers to make available for the American public."
Last week, New York state Attorney General Leticia James ordered two New York City merchants to stop charging excessive prices for hand sanitizers and disinfectant sprays. According to James' office, Ace Hardware in Midtown Manhattan was charging customers nearly $80 for 1,200 milliliters of hand sanitizer, while City Fresh Market in Astoria, Queens, was charging almost $15 for a 19-ounce bottle of disinfectant spray.
The FDA and the Federal Trade Commission have also cracked down on supplement companies and televangelist Jim Bakker for pushing unapproved drugs that purport to treat the coronavirus.
--Additional reporting by Hailey Konnath and Kevin Stawicki. Editing by Alyssa Miller.
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