Do you have hand sanitizer left over from the early days of the pandemic? It's time to dispose of it safely.

In 2020, hand sanitizer sales exploded as people tried to prepare for what turned out to be an unprecedented global pandemic. Three years later, many homes and businesses may be left with some of that hand sanitizer. It is likely nearing or past its expiration date – or there isn't an expiration date on the label – so you may be wondering if it is safe to use. This blog will help answer some of your questions.

FDA regulations during the pandemic

Alcohol-based hand sanitizer (ABHS) is an over-the-counter (OTC) drug regulated by the U.S. Food and Drug Administration (FDA). To protect public health, ABHS manufacturers must follow robust FDA regulations for quality and safety, which include specifications on ingredients, manufacturing, and labeling requirements like expiration dates.

In 2020 and 2021, the market was flooded with hundreds of off-brands, lower-quality sanitizers produced by distilleries and other companies producing hand sanitizer for the first time under temporary FDA guidance that exempted them from meeting all of the FDA's standard manufacturing quality and safety requirements.

This temporary guidance ended on Dec. 31, 2021. Unfortunately, there were many safety and efficacy issues with some of these sanitizers, and the FDA is still adding to a growing list of more than 400 hand sanitizers the FDA says to avoid.

Also, as the FDA didn't provide guidance on expiration dates, many temporary manufacturers did not include expiration dates on their labels. Due to the potentially lower quality of the components used to manufacture the hand sanitizer and the packaging used to bottle it, it may fail to meet quality requirements for safety and efficacy sooner than expected.  

Does hand sanitizer expire?

Yes, hand sanitizer does expire. Manufacturing specifications for hand sanitizer include such things as active ingredient content (like ethyl or isopropyl alcohol), color, and odor. FDA-approved manufacturers do strict stability testing to ensure the shelf life of the hand sanitizer. Those given specifications will not last forever.

Why are there expiration dates on hand sanitizer?

The expiration date indicates the end of the shelf-life for a specific product – meaning how long it retains its strength, quality, and purity when it is stored according to its labeled storage conditions. It is based on the date of manufacture of that product. The safety and efficacy of the product can be guaranteed up to the expiration date.

How long does hand sanitizer last?

Generally, the expiration date for hand sanitizer is typically 3-5 years after that product's manufacture date. The expiration date of PURELL® hand sanitizer is determined through product stability testing, and our products are typically labeled with an expiration date of 5 years from the date of manufacture. The products are best if used by that date. The expiration date of PURELL® hand sanitizer is printed on the back label in a black bar at the bottom.

Are expired hand sanitizers less effective?

Yes, expired hand sanitizers are less effective. When the active ingredient is less than its labeled amount, it will not perform as effectively – meaning it may not kill as many germs as it originally did.

What if there is no expiration date on my hand sanitizer bottle?

While the FDA requires that hand sanitizers be labeled with an expiration date if the manufacturer doesn't have data supporting at least three years of shelf life, some of the sanitizers produced under the temporary guidance during the pandemic do not have expiration dates. If there is no expiration date, contact the manufacturer and ask them what the expiry is. The manufacturer should be able to tell you when the product was manufactured and what the expiry is based on the lot/batch code printed on the package.

If there is no expiry or lot/batch code printed on the package, then we recommend that the product not be used, sold, distributed, or donated for these reasons:

• OTC Drug products are required to undergo a formal drug stability program, including evaluating their performance over long periods of time and often under elevated temperatures to have confidence in the compatibility with the packaging and so that the active ingredient remains stable, safe, and effective.
• Most likely, these products did not undergo stability testing to confirm that the liquid hand sanitizer is effective, and that the package integrity is maintained (most notably ensuring the alcohol does not evaporate, leak, and/or the package does not degrade the alcohol).
• FDA intended for the hand sanitizers manufactured under their temporary guidance to be used during the public health emergency, not indefinitely. Based on our decades of drug stability and analytical chemistry experience, we believe any hand sanitizer product made under the temporary guidance older than one year should be properly disposed of.

  What should I do with expired hand sanitizer?

  Our recommendation is to properly dispose of any hand sanitizer product that is:

• Expired, or without an expiration date,
• Not in its original labeled container or product that is mislabeled,
• Has a bad odor and/or irritates the skin,
• Does not have a lot code number.

How do I dispose of hand sanitizer?

ABHS is flammable as it typically contains at least 60 percent alcohol, so it should not be thrown in the trash or poured down the drain. The EPA says the liquid and vapors in water pipes and sewer systems can cause fires and explosions.

Proper disposal includes following all local, state, and federal disposal requirements and guidelines for hand sanitizer. Distributors should contact their local waste management and recycling center for more information on hazardous waste disposal. For more information, visit the EPA's page on "How to Dispose of and Recycle Alcohol-Based Hand Sanitizer."

Businesses interested in replacing their expired hand sanitizer with PURELL^® hand sanitizer should contact their GOJO distributor.