Hand Sanitizer

[Last updated April 6, 2020]

As the world deals with COVID-19, the demand for properly made hand sanitizers has gone through the roof. The FDA has recognized the need and put temporary policy in place which reduce the restrictions on who can make and sell hand sanitizer. For the first time, HSCG members may be able to meet the current requirements.

A hand sanitizer is a liquid or gel used to eliminate infections agents on the hands. Washing with soap and water is the preferred way to remove the COVID-19 virus from your hands, but hand sanitizer is a good alternative when you don’t have access to a sink and water.

As a member of the HSCG, we would like to provide you with all the information you need to produce safe, effective hand sanitizers. You can use them to sell or give to your family and friends for use. If you have a General & Product Liability Insurance Policy with your membership, then you are covered to make hand sanitizers provided you adhere to the rules and regulations governing their sale and manufacture.

Producing hand sanitizer could be a great product to help with your sales while the world is shut down over COVID-19. If you do decide to take on this project to sell units of hand sanitizer, be sure you follow the rules outlined by the FDA.

FDA Temporary Policy

The FDA issued their Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) in response to a shortage of hand sanitizers and requests from entities that were not licensed or registered as drug manufacturers who wanted to make hand sanitizer for personal use or for sale. The document includes all the exact requirements that must be met.

First, the hand sanitizer must follow this formulation:

All meausurements are by volume, not weight.
OR80%Alcohol (ethanol) not less than 94.4% ethanol by volume
75%Isopropyl Alcohol
1.45%Glycerin (glycerol)
0.125%Hydrogen peroxide
q.s.*Sterile distilled water or boiled cold water

q.s. quantum satis Add as much of this ingredient as is needed to achieve the desired result (100%), but not more.

Additional requirements:

  • If ethanol is used, it must be denatured in accordance with current regulations by the alcohol producer or when the hand sanitizer is made. Specificiations for denaturing can be found in Appendix C of the FDA Document Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19)
  • No other ingredients may be added (such as ingredients to improve the smell or taste); no ingredients may be substituted.
  • Care should be taken to ensure that the correct amount of the right kind of alcohol is used in the formulation. Failure to do so could render the product ineffective thereby putting the users at risk.
  • A simple record of the key steps and controls used during formulation (batch record).
  • Some sort of testing to verify the alcohol content is conducted.
  • The hand sanitizer is labeled in accordance with the label samples provided in the Temporary Policy Appendixes
  • The firm must have a way to accept adverse reaction reports.
  • The firm must register their facility and list their products.

When the current health care emergency is over, the FDA intends to discontinue this Temporary Policy and will once again require that hand sanitizers are ONLY manufactured by facilities that have undergone full registration, inspection and compliance as over-the-counter drug manufacturers.

As noted above, in order to be covered by the General and Product Liability Insurance purchased with your HSCG membership, you must comply with the Temporary Policy issued by the FDA.