The deadline for discontinuing distribution of certain alcohol-based hand sanitizers produced under temporary policies during the COVID-19 public health emergency (PHE) is March 31, 2022. On this date, manufacturers must also cease usage of ethanol prepared under COVID-19 PHE policies to manufacture a finished alcohol-based hand sanitizer.
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 allowed for flexibility regarding FDA regulations for certain hand sanitizers in response to increased demand for these products during the COVID-19 PHE.
Get assistance with meeting FDA’s requirements for manufacturing hand sanitizer.
If you manufactured hand sanitizer under COVID-19 PHE policies, your product had to comply with FDA’s regulations as of December 31, 2021, if you intended on continuing production. Registrar Corp’s Regulatory Specialists can help you meet FDA’s requirements for alcohol-based hand sanitizer so that you can continue manufacturing your product.
For more information, call us at +1-757-224-0177, email us at [email protected] or chat with a Regulatory Advisor 24-hours a day at regstaging.wpengine.com/livechat.
Keep reading to learn why FDA is transitioning out of COVID-19 policies for hand sanitizer and how to continue marketing your hand sanitizer product.
COVID-19 Policies for Manufacturing Hand Sanitizer
In March 2020, FDA published three guidances detailing temporary policies for manufacturers to produce certain alcohol-based hand sanitizer and alcohol for use in hand sanitizers during the COVID-19 PHE.
FDA regulates hand sanitizers as over-the-counter (OTC) drug products. 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 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, FDA has concluded that temporary policies helping to increase supply are no longer necessary.
FDA collected surveys from various hospitals and assessed results to reach this conclusion. According to the survey data, hospitals are no longer experiencing a disruption in hand sanitizer supply and the majority do not anticipate experiencing another shortage. The survey also revealed that traditional manufacturers currently supply most of the surveyed hospitals’ hand sanitizer.
Deadlines for Hand Sanitizers Manufacturers
In October 2021, FDA announced it was withdrawing the three guidances and called for companies manufacturing alcohol-based hand sanitizers under the temporary policies to cease production of these products by December 31, 2021 and stop selling and distributing such products by March 31, 2022.
Manufacturers that intend to continue producing hand sanitizer must now comply with the tentative final monograph for over-the-counter topical antiseptics and comply with all applicable requirements, including Current Good Manufacturing Practice requirements.
Manufacturers that do not intend to continue producing these products should deregister and delist their hand sanitizer products.
Get assistance with meeting FDA’s requirements for manufacturing hand sanitizer.
If you manufactured hand sanitizer under COVID-19 PHE policies, your product had to comply with FDA’s regulations as of December 31, 2021, if you intended on continuing production. Registrar Corp’s Regulatory Specialists can help you meet FDA’s requirements for alcohol-based hand sanitizer so that you can continue manufacturing your product.
For more information, call us at +1-757-224-0177, email us at [email protected] or chat with a Regulatory Advisor 24-hours a day at regstaging.wpengine.com/livechat.
