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 drugs, usually over-the-counter drugs. They must be manufactured by approved drug manufacturers, in registered, inspected and approved facilities. The product must follow one of several possible formulations.

In May 2020, there was a shortage of hand sanitizers. 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 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 deregister 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.

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Comments

  1. I have several questions so please bear with me – I have been researching these and am at my wits end 🙁

    1. I found unscented hand sanitizer bases – am I able to use those to add fragrance and sell through my business?
    2. Handcrafted all-purpose surface cleaners – I found a wonderful recipe I’d like to try and add to my line as well – yet cannot find any information on the labeling or legal requirements of this ( I know its not a cosmetic but I am desperate).

    3. Does Handmade laundry soap and laundry products follow the same guidelines as standard soap in Florida?

    Thank you so much 🙂

    1. Author

      Easy questions first – laundry soap and products, as well as surface cleaners are not cosmetics and don’t require cosmetic registration in Florida. I don’t believe there are other applicable regulations in Florida except what might exist in your city or county in the way of business licenses.

      Hand sanitizer is an OTC drug. The FDA allowed people to make handsanitizer during the pandemic, but that exemption was removed around the end of last year. You could buy PACKAGED and LABELED hand sanitizer that someone else (who has a drug manufacturing permit) made, but you can’t color or flavor a hand sanitizer base and sell it since you aren’t licensed as a drug manufacturer.

      1. Thank you very much! This is exactly why I asked. I will scrap that idea… as always, you are awesome.

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