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.
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.
Glycerin (glycerol) USP or Food Grade
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:
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.
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