FDA’s Final Rule on Hand Sanitizers Becomes Effective April 13, 2020

On April 13th, 2020, a rulemaking from the U.S. Food and Drug Administration (FDA) from last year will become effective. The final action demonstrates that certain active ingredients (28) should not be used in nonprescription, over-the-counter (OTC)) consumer Antiseptic Products, (Consumer Antiseptic Rubs or Consumer Rubs, also known as Hand Sanitizers), meant to be used without water.

These disqualified active ingredients (28), are not qualified for evaluation under the OTC Drug Review for use in Consumer Antiseptic Rubs. Hence, drug products holding these ineligible active ingredients are subject to approval under a new drug application (NDA) or abbreviated new drug application (ANDA) before introducing to the market. FDA is publishing this final action after taking into consideration the directions of the Nonprescription Drugs Advisory Committee (NDAC).

FDA has postponed further regulation on three active ingredients, i.e. Ethyl alcohol, Isopropyl alcohol and Benzalkonium chloride for use in OTC Consumer Antiseptic Rubs to permit sufficient time, for launching and presenting, information on data gaps, regarding the safety and effectiveness of these three ingredients. A GRAS/GRAE determination for these three active ingredients is not determined in this rule making. The establishment of monograph or non-monograph status of these three ingredients will be conveyed, either after data gaps are studied to address the safety and effectiveness of these ingredients or at a later time, if these studies are not finalized.

With consideration to the current situation regarding the COVID-19 pandemic, FDA has released temporary guidance documents for alcohol-based Hand Sanitizers. More information on this can be found below.

UL Offers Hand Sanitizer Safety Data Sheets Free Of Charge

Businesses all over the world are beginning to manufacture hand sanitizers to meet the critical need for such products. The World Health Organization (WHO) provides a “Guide to Local Production: WHO-recommended Handrub Formulations” that contains specific formulations for both ethanol-based and isopropanol-based hand sanitizers.

Additionally, in the United States, under the current public health emergency the FDA has issued a “Policy for Temporary Compounding of Certain Alcohol-based Hand Sanitizer Products During the Public Health Emergency”.

UL has created an SDS specifically for both the ethanol-based and isopropanol-based WHO-recommended hand sanitizer formulas. These Safety Data Sheets have been prepared in several regional Globally Harmonized System (GHS) formats, and we are offering them free of charge.

Get your free Hand Sanitizer SDS

Sources:

The Daily Journal of the United States Government, Federal Register, Document Number:2019-06791

https://www.federalregister.gov/documents/2019/04/12/2019-06791/safety-and-effectiveness-of-consumer-antiseptic-rubs-topical-antimicrobial-drug-products-for

Guidance for Industry: Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19)

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-temporary-policy-preparation-certain-alcohol-based-hand-sanitizer-products-during?utm_campaign=Recently%20Posted%20Guidance%20Documents%203%2F20%2F2020&utm_medium=email&utm_source=Eloqua

Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-temporary-compounding-certain-alcohol-based-hand-sanitizer-products-during-public-health