FDA’s lenience with hand sanitizer production due to COVID-19


In the wake of the global pandemic COVID-19 or Corona Virus, aside from toilet paper, there has been an increase in the use and demand of hand sanitizers or antiseptics across the globe. Hand sanitizers have become the number one in-demand product globally and are selling out faster than can be restocked at any store. Due to the increasing demand for them, the FDA has issued two guidelines in communicating the current policy when regulating the manufacturing of hand sanitizer products.

Before the pandemic, the FDA used to split anti-septics into two categories washes and rubs. An antiseptic wash product which is commonly known as antibacterial soaps are for intended use with water and is rinsed off after use. This tends to include hand washes, soaps, and body washes. The other category is the antiseptic rubs which we all know as hand sanitizer. Rubs are leave-on products like hand sanitizer as well as antiseptic wipes. These products are intended to be used when water and soap are not immediately available and are not rinsed off.

In 2016, the FDA concluded with the Consumer Antiseptic Rub (2016) ruling that the only three allowed active ingredients in products such as hand sanitizer and antiseptic wipes are benzalkonium chloride, ethyl alcohol, and isopropyl alcohol. Essentially anything classified as an antiseptic must be alcohol-based.

As a result of the increased demand for alcohol-based hand sanitizers during this outbreak, many consumers have attempted to make their own for personal use. Since there is a lot of misinformation during this time, the agency lacks information on whether the DIY methods are safe for use.

Because of the rapidly decreasing stock of hand sanitizers, the FDA has become lenient with manufacturers and companies creating their own hand sanitizers that don’t exactly follow their guidelines in order to meet their regulations. The FDA issued the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products that outlines that the agency is going to be lenient and will not take action against manufacturing firms preparing alcohol-based hand sanitizers for both consumer and health care personnel during the ongoing public health crisis. In addition, the FDA also implemented the Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency which says that when compounding the alcohols, it should be done by a licensed professional.

Since there is much lenience during this time especially with the two new policies in place, manufacturers will not have to await approval before producing their hand sanitizer. The only requirement is that the hand sanitizers must be made of the typical ingredients of alcohol, glycerol, hydrogen peroxide and water. In addition to ingredients, the manufactures must provide an ingredient lists. FDA is also relaxing that requirement for hand sanitizer, which will allow compounders to manufacture the product in bulk and sell it. Like other manufacturers, compounding pharmacies will have to follow the typical recipe and label their bottles properly.

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