Introduction:
With the outbreak of COVID-19, hand sanitizer markets reached peaks. The food and drug administration (FDA) plays a vital role in protecting the United States from emerging infectious diseases such as the coronavirus disease 2019 (COVID-19) pandemic. Throughout the pandemic, the agency assessed the needs and circumstances concerning alcohol-based hand sanitizers. It issued temporary guidance to provide regulatory flexibility to certain manufacturers to help meet the increased demand for these products. Traditional manufacturers' supply of alcohol-based hand sanitizer has increased (i.e., manufacturers other than those that began manufacturing over-the-counter drugs during emergencies to supply hand sanitizers during the COVID-19 pandemic). Most consumers and healthcare personnel no longer have trouble obtaining alcohol-based hand sanitizers. As a result, the FDA has withdrawn three guidance documents issued in March 2020 that outlined temporary policies for manufacturers who were not drug manufacturers before the public health emergency to produce specific alcohol-based hand sanitizers and alcohol for use in hand sanitizers.
What Are the FDA Guidelines for Hand Sanitizer Production?
Manufacturers of hand sanitizers can do so as long as they follow the tentative final monograph for over-the-counter topical antiseptics and other applicable requirements, such as the FDA's current goods manufacturing practices. Manufacturers who no longer intend to produce these products should deregister and delist them by following the instructions on the electronic drug registration and listing instructions page.
Due to the current crisis, the FDA issued a document outlining temporary guidelines for producing hand sanitizer products. The FDA currently grants exemptions to companies not identified as drug manufacturers and produces commercial hand sanitizers, provided certain ingredients are used, and guidelines are followed.
The temporary guidelines include the following:
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Only the following ingredients can be used:
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Isopropyl alcohol or ethanol not less than 94.9 percent by volume is to be used.
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Food chemical codex (also called "food grade") or glycerin United States Pharmacopeia (USP).
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Hydrogen peroxide.
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Sterile water.
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The alcohol (ethanol) is denatured by the manufacturer of the alcohol or when the hand sanitizer is manufactured.
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The hand sanitizer is made per the world health organization's recommended formula:
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Ethanol (80 percent volume/volume) or isopropyl alcohol (75 percent volume/volume) in an aqueous solution.
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Glycerin (1.45 percent volume/volume).
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Hydrogen peroxide (0.125 percent volume/volume).
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FDA also recommends that no other active ingredient be added to the preparation, including fragrances and scents, as it may affect the quality of the product.
FDA requirements to market over-the-counter (OTC) products like hand sanitizer include:
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Check that the active ingredients and indications are per the OTC monograph.
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Drug establishment registration.
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Obtaining the labeler code.
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National drug code drug listing.
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Comply with FDA labeling requirements for over-the-counter drugs.
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The product should be manufactured according to good manufacturing practices.
The FDA takes up to ten business days to release the labeler code, and the drug listing must be done within two business days after receiving the labeler code.
What Is FDA's Do-Not-Use List?
The FDA regulates and tests hand sanitizers for quality control as an over-the-counter drug without a prescription. During recent testing, they discovered serious safety concerns with some hand sanitizers, including:
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Contamination using toxic types of alcohol.
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Insufficient active ingredients like ethyl alcohol or isopropyl alcohol.
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Labels containing false, misleading, or unproven claims.
Some of the hand sanitizers have been recalled, and FDA recommends stopping the usage of over 150 hand sanitizers. Hence FDA has a do-not-use list that one can refer to before buying or using a hand sanitizer at home. One may check it at the FDA official website; the information on the website is constantly updated as new test results are released.
How to Search on FDA's Do-Not-Use List?
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Visit the FDA website.
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Drugs > Drug Safety and Availability > FDA updates on hand sanitizers consumers should not use
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Click the red button, "hand sanitizers consumers should not use."
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Scroll down to the search box at the top of the do-not-use list.
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Enter one of the following terms into the search box using the information on the hand sanitizer label:
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Name of a product or brand.
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The product's manufacturer or the company that created it (may not be included on the product label).
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National drug code number (may not be mentioned on the product label).
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The distributor.
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Avoid using hand sanitizers made by manufacturers mentioned in the list.
If the manufacturer is mentioned on the do-not-use list, dispose of it in a hazardous waste container. Do not flush, pour, or combine the product with other liquids. Contact the distributor for more information if the manufacturer is not mentioned on the label. The FDA advises against using the product if the distributor refuses to clarify this information when contacted.
Also, note that in hand sanitizers, only ethyl alcohol and isopropyl alcohol (or 2-propanol) are acceptable alcohols. And alcohols, such as methanol and 1-propanol, are not permitted in hand sanitizer because they are toxic to humans. Unfortunately, recent FDA testing revealed that some hand sanitizers were contaminated with these potentially toxic types of alcohol.
How to Safely Use Hand Sanitizers?
To prevent COVID-19 and several other potentially harmful diseases, it is recommended to maintain good hand hygiene by washing hands with soap and water for 20 seconds regularly. If soap and water are unavailable, the centers for disease control and prevention recommend using alcohol-based hand sanitizers containing at least 60 percent alcohol to avoid becoming ill and spreading germs to others.
Hand sanitizer should be rubbed all over the hands, including between fingers and on the backs of the hands. Avoid wiping or rinsing away the hand sanitizer before it has dried. If the hands are dirty or greasy, avoid using hand sanitizer and wash them with soap and water.
Keep these safety precautions in mind if you use alcohol-based hand sanitizers:
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Read the drug facts label carefully, especially the warnings section.
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Hand sanitizer should be kept out of reach of pets and children, and children should only use it under adult supervision.
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Avoid getting hand sanitizer in your eyes because it can cause burning and damage to the eye's surface. If you get hand sanitizer in your eyes, flush them thoroughly with water as soon as possible and contact a doctor or a poison control center.
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When using hand sanitizer in a confined space, such as a car, open the windows to improve ventilation until the hand sanitizer has dried.
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Supervise children around hand sanitizers as they can be attractive with colorful bottles and fragrances. Even a tiny amount of hand sanitizer can cause alcohol poisoning in young children. (However, there is no need to worry if your children eat or lick their hands after using hand sanitizer).
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If one suspects the pet has eaten something potentially harmful, contact the veterinarian or a pet poison control center immediately.
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Hand sanitizer must be kept away from heat and flames.
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Check the FDA's do-not-use list for the manufacturer of the sanitizer.
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The FDA does not recommend DIY (do-it-yourself) hand sanitizer. If made correctly, they can be effective or better.
Conclusion
Maintaining good hygiene can help prevent many potentially harmful diseases, including COVID-19. For example, hand sanitizers can help kill germs if used safely and effectively. The FDA regulates hand sanitizers as an over-the-counter drug and regularly conducts tests to check for the safety and efficacy of the product. When using a hand sanitizer, refer to the safety guidelines suggested by the FDA.
