Guidance on the Production of Hand Sanitizer
October 2021 Update: The Food and Drug Administration (FDA) has announced the withdrawal of the temporary guidance documents relating to hand sanitizer production during the COVID-19 crisis. Firms making alcohol for sanitizers or preparing alcohol-based sanitizers under this guidance must cease production by December 31, 2021 and cease distribution by March 31, 2022. Those wishing to continue to produce after this date may do so provided they meet the “standard" requirements for topical sanitizer production. More information and directions on deregistering producers and delisting products can be found in this document: https://public-inspection.federalregister.gov/2021-22108.pdf
The extraordinary circumstances surrounding COVID-19 have led to a shortage of hand sanitizer in many jurisdictions, including New York State. This demand exists among hospitals but also for first responders (fire, police, EMT), social services workers, employees of essential businesses, and many other individuals who are in frequent close contact with others. Total demand is challenging to estimate, but considering that a typical small hospital or grocery store needs 30 gallons/week of sanitizer, it is reasonable to assume that total demand in NY State for the groups listed above is likely on the order of 500,000 gallons of hand sanitizer per week, but current supply is much less.
To address this problem, the FDA has loosened regulations for producing sanitizer. These changes allow distilleries and other “firms” to produce sanitizer.
Chris Gerling, senior extension associate
Questions on the Production of Hand Sanitizer
There are three recent FDA guidance documents that address this question. One challenge that distilleries have is that all three were released near-simultaneously (Mar 26-27, 2020) and have similar sounding names. Make sure you are consulting the correct document.
A. Document: “Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency Immediately in Effect Guidance for Industry”
Who should care about this: Pharmacies that intend to blend sanitizer
B. Document: “Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) Guidance for Industry”
Who should care about this: “Firms”, including distilleries, which are not currently licensed to produce over-the-counter (OTC) drugs but intend to produce sanitizer
C. Document: "Temporary Policy for Manufacture of Alcohol for Incorporation Into AlcoholBased Hand Sanitizer Products During the Public Health Emergency (COVID-19)"
Who should care about this: Producers of ethanol (alcohol) who wish to have their products used for blending sanitizer, even if their ethanol does not meet the usual standards expected for use in drugs, This is especially relevant to food- or bioethanol producers who plan to blend sanitizer, or to sell ethanol to other firms to blend.
Of these, Document B is the most relevant to distilleries or related firms. The key points are that the FDA will not “take action” against the distillery (or other firm) so long as they follow the instructions in the document. Key points are as follow
- The firm registers with the FDA as a producer and lists their products
- The firm abides by the FDA guidelines for making the product, which includes very specific guidelines for two different formulations, one based on 75% isopropanol, the other on 80% ethanol. This is described in more detail below.
Document C is also relevant to distilleries. Most distilleries will be purchasing ethanol rather than using their own, as described below. The guidelines in Document C describe the facilities suitable for producing ethanol for sanitizer production.
One key point: just because you want to blend sanitizer does not mean that you *should* blend sanitizer. The sanitizer formulations described in the FDA guidelines are highly flammable, and the typical winery, brewery or cidery may not be equipped for their safe production. This is discussed more below.
The sanitizer formula is provided in Document B (see Question 1 above).
a. (Select one of two options) (1) Alcohol (ethanol) that is not less than 94.9% ethanol by volume; OR (2) Isopropyl Alcohol
b. Glycerin (glycerol) United States Pharmacopeia (USP) or Food Chemical Codex (also known as “food grade”)
c. Hydrogen peroxide
d. Sterile water (e.g., by boiling, distillation, or other process that results in water that meets the specifications for Purified Water USP). Water should be used as quickly as possible after it is rendered sterile or purified.
Used in the following concentrations:
- Alcohol (ethanol) (80%, volume/volume (v/v)) in an aqueous solution; or Isopropyl Alcohol (75%, v/v) in an aqueous solution.
- Glycerin (glycerol) (1.45% v/v).
- Hydrogen peroxide (0.125% v/v).
- Sterile distilled water or boiled cold water.
Note: The compounder does not add other active or inactive ingredients, such as ingredients to improve the smell or taste due to the risk of accidental ingestion in children. Different or additional ingredients may impact the quality and potency of the product.
If you are a producer, we recommend that you do not get creative. Do the recipe as described. However, if you have ideas for alternative formulations, you can send a request to the FDA. Information on how to do this is in Document B.
Ethanol can be sourced through normal distillation processes or procured from a registered ethanol producing plant. For most distilleries, it will make more financial sense to buy inexpensive alcohol from a large-scale producer for a few dollars per gallon rather than rectify their own spirits, which they could sell for $30+ for 750 mL. Put another way: most distilleries will be better served acting as sanitizer blenders (Document B, see Question 1 above) rather than ethanol producers.
Based on current FDA guidelines (as of April 3, 2020), the ethanol must be denatured, as described in the next section.
In its original guidelines (Document C, see Question 1 above), the FDA allowed for either USP or food-grade ethanol, but recent articles indicate that fuel ethanol will also be allowed, with some restrictions. https://www.nytimes.com/aponline/2020/03/31/business/ap-us-virus-outbreak-hand-sanitizer.html. As of April 3, this document is not yet published, but is presumably forthcoming.
Permit guidance for alcohol fuel plants (AFPs) and beverage DSPs: TTB is exempting AFPs and beverage DSPs from the requirement to obtain additional permits or bonds to manufacture hand sanitizer or to supply ethanol for use in the manufacture of hand sanitizer to other TTB permittees who are authorized to receive such distilled spirits. TTB is authorizing this exemption under 26 U.S.C. 5562. AFPs and beverage DSPs must continue to keep records of their operations, including any undertaken as authorized under this exemption.
Assuming you purchase or produce undenatured ethanol, the FDA lists three approved methods for denaturing the ethanol, selected from TTB methods
Reference: https://www.law.cornell.edu/cfr/text/27/21.76 and https://www.law.cornell.edu/cfr/text/27/21.37
40-A (a) Formula. To every 100 gallons of alcohol add: One pound of sucrose octaacetate and 1/8 gallon of tert-butyl alcohol.
40-B (a) Formula. To every 100 gallons of alcohol add: One-sixteenth avoirdupois ounce of denatonium benzoate, N.F., and 1/8 gallon of tert-butyl alcohol.
Note: tert-butyl alcohol is not currently required for 40-A or 40-B.
3-C (a) Formula To every 100 gallons of alcohol add: Five gallons of isopropyl alcohol.
This is addressed fully in https://www.ttb.gov/public-guidance/ttb-pg-2020-1a. Check there for more details, but the salient parts are below
“Tax-free ethanol may be used to produce hand sanitizer if it is denatured according to TTB regulations and Food and Drug Administration (FDA) guidance.
Alcohol, whether or not denatured, may be delivered tax-free to state and local governments for non-beverage purposes. The same is true for hospitals, blood banks, sanitariums, certain pathological laboratories, non-profit clinics, and qualifying educational institutions, if not for resale or use in the manufacture of any product for sale.”
For hydrogen peroxide, the Instructions in the FDA guidelines, footnote 10, https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-temporary-policy-preparation-certain-alcohol-based-hand-sanitizer-products-during state the following is acceptable:
“Hydrogen Peroxide Concentrate USP or Hydrogen Peroxide Topical Solution USP. Technical grade hydrogen peroxide falls within this policy if the concentration is within that of Hydrogen Peroxide Concentrate USP or Hydrogen Peroxide Topical Solution USP”
Thus USP grades are fine, but most producers report difficulty sourcing USP hydrogen peroxide. Diving into the US Pharmacopeia (USP) guidelines
Hydrogen Peroxide Concentrate USP must contain 29-32% w/w H2O2 http://www.uspbpep.com/usp31/v31261/usp31nf26s1_m38580.asp
Hydrogen Peroxide Topical Solution USP must contain 2.5-3.5% w/v H2O2
http://www.uspbpep.com/usp31/v31261/usp31nf26s1_m38590.asp
Based on this, technical grade hydrogen peroxide must have either 29-32% w/w or 2.5-3.5% w/v. Unfortunately, most technical grade is 34% w/w peroxide, which is not within current guidelines. We have heard of at least one producer asking their supplier to predilute the hydrogen peroxide before sending it.
Glycerin (also called glycerol) must be USP or food-grade.
Alcohol at 70-80% is extremely flammable, with a flashpoint at or even below room temperature. Facilities must have adequate ventilation to prevent the build-up of vapor, and these mixtures should not be pumped through traditional beverage transfer pumps. Explosion-proof pumps must be used. Also, mechanical packaging lines may not be rated for use at such high ABV. Check with manufacturers before using any mechanical equipment to transfer or package sanitizer.
https://www.winebusiness.com/news/?go=getArticle&dataId=228500
So, if you are winery (or dairy; or cidery; or something else) you probably are not going to be able to blend and package hand sanitizer.
If you are interested in providing for hospitals or municipal workers, keep in mind that NY State is producing a 75% isopropanol-based sanitizer (“NY Clean”) and providing this for free, although anecdotally some places still do not have sufficient supply. Depending on their supply, these groups may not be interested in your 80% ethanol sanitizer unless you are donating the product.
The American Craft Spirits Association has also launched a “marketplace” for people looking to buy and sell sanitizer:
https://americancraftspirits.org/covid-19/
If you are interested in selling a product, and are looking for a customer, there are several resources in NY.
We have heard from several distilleries about challenges with sourcing both ingredients (especially hydrogen peroxide) at appropriate grades. If you find a source at a lower grade, please consider writing a request to the FDA to allow for its usage. Details for making the request are in Document B.
The Distilled Spirits Council of the US has a resource page for distillers to list their names, and to assist those who need supplies or distribution help:
https://www.distilledspirits.org/distillers-responding-to-covid-19/
The American Craft Spirits Association also has resources available for those making, buying, and selling hand sanitizer: