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Healthy Supply Chain Leads FDA to Withdraw COVID-19 Ethanol Sanitizer Provisions

America’s hand sanitizer supply chain is off the ropes and again running like a fine-tuned machine.

The U.S. Food & Drug Administration has essentially issued a cease and desist directive to manufacturers of ethanol hand sanitizers prepared under COVID-19 Public Health Emergency policies to manufacture a finished alcohol-based hand sanitizer.

The federal mandate is clear: If a hand sanitizer is not currently FDA compliant, it must be off the shelves. The distribution deadline was March 31, 2022.

The U.S. Food and Drug Administration (FDA) instituted the March 31 deadline when it withdrew three guidance documents outlining temporary policies for manufacturing alcohol-based hand sanitizer products during the COVID-19 PHE. The policies previously provided flexibility regarding FDA regulations for certain hand sanitizers in response to increased demand for these products during the COVID-19 PHE.

The FDA’s new mandate is a refreshing sign of the country’s continued sanitizer supply chain recovery from the height of the COVID-19 pandemic. Any hand sanitizer manufactured under COVID-19 PHE policies must have complied with FDA regulations as of December 31, 2021 if continued manufacturing was intended.

Basically, as Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research, notes, the COVID-19 flexibility guidelines were no longer needed as the U.S.’s supply of alcohol-based hand sanitizers has rebounded and is now healthy. The supply chain rebound is a sharp contract to the empty shelves and allocation mandates of the dark early days of the Pandemic in 2020 when the nation was in dire need of sanitizer to protect against the then-mysterious coronavirus.

“The FDA is committed to providing timely guidance to support continuity and response during the COVID-19 pandemic,” Cavazzoni said. “Throughout the pandemic, the agency has continuously accessed the needs and circumstances related to hand sanitizers and issued temporary flexibility to certain firms to help meet the increased demand.

“As relevant needs and circumstances evolve, the FDA updates, modifies or withdraws policies as appropriate. In recent months, the supply of alcohol-based hand sanitizer from traditional suppliers has increased, and now, most consumers and healthcare personnel are no longer having difficulty obtaining these products.”

The country’s now healthy sanitizer supply line initiated the FDA’s policy change.

“We have determined it’s appropriate to withdraw the temporary guidances and are providing manufacturers time to adjust their business plans related to the production of these products under these temporary policies.”

The FDA surveyed various hospitals across the country and assessed results before arriving at the conclusion. The survey data showed American hospitals are no longer experiencing a disruption on hand sanitizer supply and the majority do not foresee experiencing another shortage. The study also confirmed traditional manufacturers currently supply most of the country’s hospital hand sanitizer.

“FDA regulates hand sanitizers as over-the-counter (OTC) drug products,” Register Corp reports. “These guidances enabled firms that were not drug manufacturers at the time to manufacture and distribute certain hand sanitizers to meet high demand during the COVID-19 PHE. Manufacturers needed to follow the policies outlined in the guidances to manufacture and distribute hand sanitizers that did not meet the FDA’s applicable regulations.

“Since the temporary policies’ inception, traditional manufacturers that were producing alcohol-based hand sanitizer before the COVID-19 PHE have increased their supply while public demand for these products has decreased. Because consumers and health care facilities no longer face challenges obtaining alcohol-based hand sanitizer, the FDA has concluded that temporary policies helping to increase supply are no longer necessary.”

And that’s great news for both the country’s hand sanitizer supply chain and America’s continued recovery from the COVID-19 pandemic.


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