TAGS: Toiletries
The U.S. Food and Drug Administration has announced that it intends to withdraw, effective 31 December 2021, guidance originally issued in March 2020 outlining temporary policies for manufacturers that were not drug manufacturers at the time to produce certain alcohol-based hand sanitizer and alcohol for use in hand sanitizers during the public health emergency.
Guidance Issued to Meet 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. Therefore, FDA has determined it’s appropriate to withdraw the temporary guidance and are providing manufacturers time to adjust their business plans related to production of these products under these temporary policies.
Effective 31 December 2021, companies manufacturing alcohol-based hand sanitizers under the temporary policies must cease production of these products. After that date, manufacturers wishing to continue producing hand sanitizer can do so provided they comply with the tentative final monograph for over-the-counter topical antiseptics and other applicable requirements, including the FDA’s Current Good Manufacturing Practice requirements.
Not to be Sold After 31 Mar 2022
Manufacturers who no longer plan to produce these products are able to deregister by following the instructions on the Electronic Drug Registration and Listing Instructions page. Hand sanitizers manufactured before the effective date and produced under the temporary guidance can no longer be sold or distributed by manufacturers after 31 March 2022.
The FDA commends all manufacturers, big and small, who stepped in to provide American consumers and health care professionals with hand sanitizer products while they were in high demand during the pandemic. FDA stands ready to help those who no longer plan to produce hand sanitizers, as well as help those who wish to continue doing so, to ensure they are complying with the appropriate requirements.
List of Hand Sanitizers
Source: FDA