The hand sanitizer shortage has caused the FDA to issue the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) Guidance for Industry. My inbox has been busy with people asking me to break down the regulation in simple terms ever since I wrote FDA Update Regarding Hand Sanitizer Regulations. So here it goes…
From one business to another I would be remiss to skip advising you to check if your business insurance will allow for you to sell this temporary OTC formula. I do know that effective immediately, Indie Business Network members with product liability insurance through IBN’s program with Veracity Insurance Services have coverage to handmade hand sanitizer, so long as they are in compliance with FDA’s Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency.
- Alcohol (ethanol) that is not less than 94.9% ethanol by volume OR Isopropyl Alcohol
- Glycerin (glycerol) United States Pharmacopeia (USP) or Food Chemical Codex (also known as “food grade”)
- Hydrogen peroxide.
- Sterile water (distilled or deionized water)
- Packaging (The allowed formula will be water thin. You may want to consider a sprayer bottle.)
If you chose to use ethanol it must either be denatured by the alcohol producer or by the hand sanitizer producer at the time of production. Some suggested denaturing steps the manufacturer can take include:
- § 21.75 Formula No. 40–A. (a) Formula. To every 100 gallons of alcohol add: One pound of sucrose octaacetate and 1⁄8 gallon of tert-butyl alcohol.
- § 21.76 Formula No. 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.
- § 21.37 Formula No. 3–C. (a) Formula. To every 100 gallons of alcohol add: Five gallons of isopropyl alcohol.
The hand sanitizer must be manufactured according to the following formula consistent with World Health Organization (WHO) recommendations:
- 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.
- NOTHING ELSE. You cannot improve smell, taste, function, or feel of the final formula.
This formula is by volume measurement only—not by weight.
Requirements to put the product onto the market.
- Insurance that covers OTC product.
- Documentation of formula used and what controls you took to make sure the formula is an exact match.
- Sanitary conditions and equipment that is appropriate for the manufacturing of an OTC formula.
- Accurate volume measuring equipment.
- Verification of the alcohol content. This can be via gas chromatography (GC), alcoholmeter, hydrometer, or other chemical analysis of at least equivalent accuracy. The sample tested should be performed before packaging the product for distribution. This hydrometer goes 0-200 proof.
- Accurate labels including a drug panel. The hand sanitizer is labeled consistent labeling in Appendix A, Appendix B, Appendix C, or Appendix D which can all be found here.
- Register your facility and list the hand sanitizer product in the FDA Drug Registration and Listing System here. Once you have registered you do not have to wait for the FDA before you start to manufacture and distribute.
Remember that this is a temporary measure. Do not totally revamp your business to solely depend on hand sanitizer sales long term. This is a temporary way to pivot during the crisis caused by the COVID 19 pandemic crisis. Also don’t make any outrageous claims. Just keep it all simple.
Source of information for this blog post comes from the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) Guidance for Industr