FDA Withdrawing Temporary Guidances for Alcohol-Based Hand Sanitizers

Official Message No.:111090-10-12-2021-PHIN
Contact Info: Eric | jaime.ahn@doh.nj.gov
Attachments: No

FDA Withdrawing Temporary Guidances for Alcohol-Based
Hand Sanitizers  

Today, the U.S. Food and Drug Administration announced that it intends to withdraw, effective Dec. 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 sanitizer and alcohol for use in hand sanitizers during the public health emergency.

Effective Dec. 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.

This information has been broadcasted to: NJDOH Staff; NJLINCS Community; DHSS Senior Staff; DHSS Staff; LINCS Coordinator Backups; LINCS Coordinators; LINCS Epidemiologists; LINCS Health Educators; LINCS Health Officer Assistants; LINCS Health Officers; LINCS Health Planners; LINCS IT Specialists; LINCS Partnership Coordinators; LINCS Public Health Nurses; LINCS Regional Health Planners; LINCS REHS; LINCS Team Members; LOCAL CD Investigators; LOCAL Epidemiologists; LOCAL Health Educators; LOCAL Health Officers; LOCAL Public Health; LOCAL REHS; Public Health Sector; Local Boards of Health; Public Health Associations; Public Health Council; Food Safety Organizations;