FDA Policy Change on Hand Sanitizers

On October 12th, 2021, the FDA announced they are withdrawing their temporary policies allowing manufacturers who were not drug manufacturers to produce certain alcohol-based hand sanitizers.

Background

In the US (and elsewhere) hand sanitizers are classified as drugs—usually over-the-counter drugs. They must be manufactured by approved drug manufacturers in facilities that are registered, inspected, and approved. Drug manufacturers must follow one of several possible formulations.

In May 2020, there was a shortage of hand sanitizers due to the Covid-19 pandemic. In order to get more hand sanitizers on the market quickly, the FDA created some temporary policies and guidances which allowed manufacturers to make hand sanitizers, even if they weren’t already set up as drug manufacturers. Companies who wanted to make hand sanitizers under the temporary rule had to register (but requirements were waived) and had to  follow one allowed formulation for their hand sanitizer.

The Change-Over

As of December 31, 2021 all companies manufacturing alcohol-based hand sanitizers under the temporary policies must cease production of those products.

As of March 31, 2022, hand sanitizers manufactured on or before December 31, 2021 and produced under the temporary policies may no longer be sold to wholesalers or retailers.

Manufacturers who registered under the temporary policy and no longer plan to produce these products should de-register by following the instructions here.

Manufacturers who want to continue producing hand sanitizers must go through the entire process of getting their facility registered and approved as a drug manufacturing facility. Obviously, a drug manufacturing facility can’t be located in a residence. Information on the good manufacturing practices for drug manufacturers can be found here and here.

Hand Sanitizer Warnings

It’s not surprising that during the time of reduced requirements by the FDA and a massive increase in sales of hand sanitizers, some unscrupulous manufacturers took advantage.

The FDA has been monitoring and testing hand sanitizers on the market. They currently have a list of 260 unsafe hand sanitizers which are published on the FDA’s Hand Sanitizer Do-Not-Use List.

How to Search the Do-Not-Use List

To check if the hand sanitizer you use is on the list:

1. Go to www.fda.gov/handsanitizerlist.
2. Click or tap on the red button that says, “Hand sanitizers consumers should not use.”
3. Scroll down the page to the search box at the top of the do-not-use list.
4. Using the information on the hand sanitizer label, type one of the following in the search box:
   • Product or brand name
   • Manufacturer, or the company that produced the product (may not be included on the product label)
   • Distributor, the company that brings the product to market
   • NDC or National Drug Code number (may not be included on the product label)
5. Do not use any hand sanitizer made by manufacturers on the list.