mdi Consultants, Inc
Public Safety Alert: Stricter Guidelines Issued by the FDA for Alcohol-Based Hand Sanitizers Will Go Into Effect for 2022 – Pre-COVID Requirements Will Resume
As we progress under the COVID rules that were put into effect as part of the EUA, the FDA is starting to rescind these EUAs as the supply shortages have been addressed and the needs have been covered.
Now the FDA is addressing the EUA on the Alcohol Based Hand Sanitizers. The FDA needs to put these products back under their control and these products need to be manufactured in FDA registered facilities and under the cGMPs. (21CFR210). We knew that this was going to happen at some time.
“The U.S. Food and Drug Administration announced that it intends to withdraw, effective December 31, 2021 guidances originally issued in March 2020 outlining temporary policies for manufacturers that were not drug manufacturers at the time to produce certain alcohol-based hand sanitizers and alcohol for use in hand sanitizers during the public health emergency.”
Effective December 31, 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.
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 or on December 31, 2021, and produced under the temporary guidances must no longer be sold to wholesalers or retailers by March 31, 2022.
If you need any assistance with the registration process and/or understanding the FDA cGMP regulations for manufacturing these OTC drug products do not hesitate to contact us.
mdi will continue to monitor the FDA’s recommendations and warnings regarding alcohol based hand sanitizers and the effect on consumer safety. For more information on this FDA policy please contact mdi at: info@mdiconsultants.com and ref: FDA alternate inspections.