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Why is this important?

Hand hygiene is an essential part of the response to COVID-19. It is important to wash your hands frequently with soap and water for at least 20 seconds, especially after going to the bathroom, before eating, and after coughing, sneezing or blowing one’s nose.

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Note: This page was last edited April 1, 2020. Please refer to the CDC and FDA for the latest updates

FDA guidelines on who can compound

The FDA released a guidance document in response to the coronavirus (COVID-19) pandemic for the temporary compounding of alcohol-based hand sanitizer products by pharmacists in State-licensed pharmacies or Federal facilities and registered outsourcing facilities (to be referred to collectively as compounders).

The FDA guidance document recognizes that compounders are more familiar with standards and methods for producing drug products. This guidance will be followed for the duration of the public health emergency declared by the Secretary of Health and Human Services (HHS) on January 31, 2020. The FDA guidance documents are not legally enforceable, but are there to describe their view on the topic and provide their recommendations.

FDA guidelines on how to compound hand sanitizers

FDA does not intend to take action against compounders that prepare alcohol-based hand sanitizers for consumers and health care providers for the duration of this public health emergency so long as the following circumstances are met:

1. The hand sanitizer is compounded using only the following ingredients in the preparation of the product: a. Either Alcohol (ethanol) that has a minimum of 94.9% ethanol by volume OR Isopropyl Alcohol b. Glycerin (glycerol) that is food-grade c. Hydrogen peroxide d. Sterile water (achieved through boiling, distillation, or other processes that results in water that meets the specifications for Purified Water USP). Water should be used as quickly as possible after it has been sterilized or purified.

2. The alcohol (ethanol) should be denatured either by the alcohol producer or at the point of production of the finished hand sanitizer product. Formulas for adequately denaturing alcohol can be found under the Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20 and 21 found here: https://www.govinfo.gov/content/pkg/CFR-2002-title27-vol1/pdf/CFR-2002-title27-vol1-part21.pdf

3. The hand sanitizer is compounded according to the following formula consistent with World Health Organization (WHO) recommendations: a. Alcohol (ethanol) (80%, volume/volume (v/v)) in an aqueous solution OR Isopropyl Alcohol (75%, v/v) in an aqueous solution. b. Glycerin (glycerol) (1.45% v/v). c. Hydrogen peroxide (0.125% v/v). d. Sterile distilled water or boiled cold water.

According to the FDA, the compounder should not add other active or inactive ingredients, such as those that would improve the smell or taste due to the risk of accidental ingestion in children. Additionally, different or additional ingredients can impact the quality and potency of the product.

4. The compounder must pay close attention to ensure the ethanol or isopropyl alcohol active ingredient is correct and they have used the correct amount of the active ingredient.

5. The hand sanitizer should be prepared under conditions routinely used to compound similar non sterile drugs.

6. The hand sanitizer should follow the labeling instructions provided in the instructions below:

Important Information on Labeling:

A. For further information on the package and drug facts labeling required on all compounded hand sanitizers for Ethyl Alcohol Formulations made specifically for consumers please see page 5 of the FDA guidance linked here https://www.fda.gov/media/136118/download

B. For further information on the package and drug facts labeling required on all compounded hand sanitizers for Isopropyl Alcohol Formulations made specifically for consumers please see page 6 of the FDA guidance linked here https://www.fda.gov/media/136118/download

C. For further information on the package and drug facts labeling required on all compounded hand sanitizers for Ethyl Alcohol Formulations made specifically for healthcare personnel please see page 7 of the FDA guidance linked here https://www.fda.gov/media/136118/download D. For further information on the package and drug facts labeling required on all compounded hand sanitizers for Isopropyl Alcohol Formulations made specifically for healthcare personnel please see page 8 of the FDA guidance linked here https://www.fda.gov/media/136118/download