Understanding FDA temporary policy for Hand sanitizer -Updated 15th April 2020

22

Apr

2020

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

To prepare hand sanitizer as per the FDA’s temporary policy, you should consider compliance with the below requirements.

Because of the public health emergency posed by COVID-19, FDA does not intend to take action against firms6 that prepare alcohol-based hand sanitizers for consumer use and for use as health care personnel hand rubs7 for the duration of the public health emergency declared by the Secretary of HHS on January 31, 2020, provided the following circumstances are present.

1. Choice of Active ingredients

You have to choose active ingredients from the below two options.

(1) Alcohol (ethanol) that is not less than 94.9% ethanol by volume; OR

(2) United States Pharmacopeia (USP grade) Isopropyl Alcohol

Further, special caution should be taken to ensure any other chemicals on site are not introduced into the ethanol either intentionally or via cross-contamination.

The alcohol (ethanol) is denatured either by the alcohol producer or at the point of production of the finished hand sanitizer product.

FDA has published a temporary policy for alcohol producers for use in the hand sanitizer.

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/temporary-policy-manufacture-alcohol-incorporation-alcohol-based-hand-sanitizer-products-during

2. Choice of Inactive ingredients  

Glycerin (glycerol) USP or Food Grade

Hydrogen peroxide

Sterile water (e.g., by boiling, distillation, or other processes that results in water that meets the specifications for Purified Water USP)

The hand sanitizer is manufactured according to the following formula consistent with the World Health Organization (WHO) recommendations:

1. Alcohol (ethanol) (formulated to 80%, volume/volume (v/v)) in an aqueous solution; or Isopropyl Alcohol (formulated to 75%, v/v) in an aqueous solution. 18 ,19
2. Glycerin (glycerol) (1.45% v/v).20 c.
3. Hydrogen peroxide (0.125% v/v).
4. Sterile distilled water or boiled cold water.

The firm 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.

Other requirements.

• Comply with registration /listing requirements- after submission of drug listing your product will appear on the FDA website. Upon completion of registration and listing, firms receive an automatic confirmation from the FDA. They do not need to wait for further communication from the FDA before they begin to manufacture and distribute these products. FDAbasics can assist firms in complying with registration and listing in the shortest period. Please write to us at [email protected] for detailed information.

• The firm does not add other active or inactive ingredients, such as ingredients to improve the smell or taste.

• Pay attention on accuracy of the active ingredient  (ethanol or isopropyl alcohol), maintain the records of active ingredient added in each batch.

• An accurate testing method such Gas Chromatography should be adopted for alcohol content in each batch.

• The hand sanitizer product is produced as an aqueous solution and not as a gel, foam, or aerosol spray.

• Comply with labeling requirements ( see the image below)

Disclaimer – FDAbasics LLC publishes the above article based on our current thinking on the FDA ‘s “Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) Guidance for Industry”. The information contained in this site is provided for informational purposes only and should not be construed as legal advice on any subject matter. You should not act or refrain from acting based on any content included in this site without seeking legal or other professional advice. FDAbasics LLC is a private consulting firm and NOT associated with US Food and Drug Administration.