Contact

What are you looking for?

Withdrawal of Temporary Hand Sanitizer Policies in the USA

October 27, 2021

Effective December 31, 2021, the US FDA will withdraw the temporary policies for producing alcohol-based hand sanitizers.

Considering a stable supply of alcohol-based hand sanitizer from traditional suppliers, the US Food and Drug Administration (FDA) announced on October 12, 2021 the withdrawal of temporary policies issued in March 2020 for non-drug manufacturers to produce certain alcohol-based hand sanitizers and alcohol for use in hand sanitizers during the public health emergency. 

Effective December 31, 2021, production of hand sanitizer shall comply with the tentative final monograph for over-the-counter topical antiseptics and relevant Good Manufacturing Practice (GMP) requirements. 

Producers who have been producing hand sanitizers under the temporary policies must stop making new hand sanitizer on December 31, 2021, and must stop distribution of any remaining hand sanitizer products produced under the guidances by March 31, 2022.

Reference

  1. FDA In Brief: FDA Withdrawing Temporary Guidances for Alcohol-Based Hand Sanitizers

With the development of new products, regulations for cosmetics, personal care and household are fast changing and increasingly complex. To stay up-to-date with the latest legislation, check out our powerful regulatory compliance platform, SGS Digicomply

Next Step

Producers that had been producing hand sanitizers under the temporary policies should not distribute the manufactured hand sanitizers after  March 31, 2022. 

For inquiries, please contact:

Queenie Ho-yan TSE 
Technical Services Manager
t: +852 2765 3672


© SGS Group Management SA - 2021 - All rights reserved - SGS is a registered trademark of SGS Group Management SA. This is a publication of SGS, except for 3rd parties’ contents submitted or licensed for use by SGS. SGS neither endorses nor disapproves said 3rd parties contents. This publication is intended to provide technical information and shall not be considered an exhaustive treatment of any subject treated. It is strictly educational and does not replace any legal requirements or applicable regulations. It is not intended to constitute consulting or professional advice. The information contained herein is provided “as is” and SGS does not warrant that it will be error-free or will meet any particular criteria of performance or quality. Do not quote or refer any information herein without SGS’s prior written consent.

Stay on top of regulatory changes within your industry
Read more articles for the Consumer Goods and Retail industry

News & Insights

  • SGS SafeGuardS

1 Place des Alpes,

P.O. Box 2152, 1211,

Geneva, Switzerland