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

SAFEGUARDS | Cosmetics, Personal Care & HouseholdNO. 144/21

 SG 14421 Sanitizer

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

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