On March 16, 2020, FDA published a notice in the Federal Register, lowering the market access threshold for alcohol-based disinfection products.Companies may manufacture and sell alcohol-based hand sanitizers in accordance with FDA guidelines for the manufacture of alcohol-based sanitizers.Some of the guidelines are reproduced below:
Because of the public health emergency caused by COVID 19, the FDA will not take legal action against companies that sell alcohol hand sanitizers if such products meet the following conditions:
1. Hand sanitizers are formulated in accordance with the requirements of the United States pharmacopoeia or recommended by who, as follows:
A. Alcohol (ethanol) (80%, v/v) or isopropanol (75%, v/v);
B. glycerol (1.45%, v/v);
C. Hydrogen peroxide (0.125%, v/v);
D. sterile distilled or cold boiled water.
2. The active ingredients of ethanol or isopropanol shall be ensured to be correct and in the correct dosage.
3. Hand sanitizers shall be manufactured under hygienic conditions and the equipment used shall be properly maintained to be suitable for the production of such products.
4. Manufacturers need to use accurate analytical methods to verify the alcohol content of finished products.Methods may include gas chromatography (GC), alcohol meter, hydrometer, or other chemical analysis methods.
5. Labels of hand sanitizers should be made according to the appendix of the guidelines.
6. Manufacturers are required to register with the FDA.
GST welcomes all customers to consult us on the testing, FDA registration and CE certification of alcohol disinfection products. I believe that your work and my work will contribute to the fight against the epidemic in all parts of the world.GST also provides testing services for a wide range of consumer products. You are welcome to contact us for testing and other compliance issues related to children's products, textiles and fashion products as well as electrical and electronic products.
Note: the above translation is for reference only.
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