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FDA has published Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products

14

Mar

2020

Summary of  FDA guidance for alcohol based hand sanitizers (temporary policy)

 

FDA has published Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products . Here is the summary of FDA’s temporary policy for hand sanitizers.

Because of the public health emergency posed by COVID-19, FDA does not intend to take action against compounders that prepare alcohol-based hand sanitizers for consumer use 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. The hand sanitizer is compounded using only the following United States Pharmacopoeia USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

a. Alcohol (ethanol) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20; or Isopropyl Alcohol (75%, v/v) in an aqueous solution

b. Glycerol (1.45% v/v).7

c. Hydrogen peroxide (0.125% v/v).

d. Sterile distilled water or boiled cold water.

The compounder does not add other active or inactive ingredients. Different or additional ingredients may reduce the safety and effectiveness of the product.

2. The compounder pays particular attention to ensure the ethanol or isopropyl alcohol active ingredient is correct and the correct amount of the active ingredient is used.

3. The hand sanitizer is prepared under conditions routinely used by your facility to compound similar non sterile drugs.

4. The hand sanitizer is labeled consistent with the below mentioned  labeling format.

hand sanitizer labeling  requirements

Here is the link for guidance document published by FDA.

If you have any questions, contact us. 

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