On April 15, 2020, the Food and Drug Administration (FDA) updated its three hand sanitizer guidance documents to address the use of fuel- and technical-grade ethanol as an active pharmaceutical ingredient (API) in hand sanitizer products during the COVID-19 pandemic. Specifically, FDA modified its current thinking regarding the use of fuel- and technical-grade ethanol as an API in hand sanitizer products during the COVID-19 pandemic.
The April 15 revisions to the guidance documents are the most recent in a series of amendments the FDA has made over the past several weeks to address the shortage of hand sanitizer products. Use the links below to read the guidance documents in full and read on for a summary of the high-level changes in each revision.
- Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19)
- Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19)
- Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency
Ethanol for Use in Hand Sanitizer Products During COVID-19 Pandemic
In response to the shortage of hand sanitizer products, FDA issued guidance expanding the ability of companies to produce alcohol as an API in hand sanitizer products. These initial guidance documents required that the alcohol used as an API in the hand sanitizer products should meet the purity standards for USP or FCC grade. In late March, FDA updated these three guidance documents to remove the USP / FCC grade requirement and to provide clarification that alcohol used as an API for hand sanitizer products under these temporary policies should be “not less than 94.9% ethanol by volume” if derived from distillation or fermentation processes. FDA emphasized that alcohol derived from synthetic processes was still required to meet USP or FCC grade.
FDA Modified Guidance Regarding Fuel- and Technical-Grade Ethanol
On April 15, 2020, FDA again revised its three hand sanitizer guidance documents. FDA added specific language in each of the three guidance documents regarding the use of fuel- and technical-grade ethanol as an API in hand sanitizer products. FDA’s revised guidance reemphasizes that no additives or other chemicals should be added to the ethanol being used as an API. However, FDA added back its statement that fuel- or technical-grade ethanol “should only be used if it meets USP or FCC grade requirements and the ethanol has been screened for any other potentially harmful impurities not specified in the USP or FCC requirements.” Notably, FDA did not prohibit the use of fuel- and technical-grade alcohol.
Importantly, FDA provided an avenue that allows the use of fuel- or technical-grade ethanol even if it does not meet the impurity level criteria under USP. FDA’s revised guidance details a process whereby an ethanol producer may submit its testing results to FDA for additional assessment. This process requires an ethanol producer to email its USP testing data to FDA at COVID-19-Hand-Sanitizers@fda.hhs.gov with “ETHANOL DATA” in the subject line. FDA will then review the testing information and respond to the producer as to whether the ethanol may be utilized as an API in hand sanitizer products during the COVID-19 pandemic and/or engage in further discussion with producer about the testing data. Indeed, during discussions with FDA, the agency clarified with greater specificity that fuel- and technical-grade alcohol that does not meet USP / FCC standards may be acceptable for hand sanitizer. FDA emphasized that it “does not intend to take action against alcohol production firms for the duration of the public health emergency,” provided industry’s good faith attempts to follow its guidance and recommendations.
For additional information, please consult the COVID-19-Related Guidance Documents for Industry, FDA Staff and Other Stakeholders.
As the number of cases around the world grows, Faegre Drinker’s Coronavirus Resource Center is available to help you understand and assess the legal, regulatory and commercial implications of COVID-19.