On 10/12/21, the FDA announced firms preparing alchohol-based hand sanitizers under temporarily revised policies must cease production by 12/31/21 and must cease distribution by 3/31/22. Check inventory for the following:

• Short Ingredient List – If the product has only alcohol, glycerin, hydrogen peroxide, and water, and is a thin liquid, then it likely was created as part of the temporary guidance.
• No Ingredient List
• Past Expiration Date
• Does Not Have a Lot Code
• Bad Odor and/or Irritates Skin
• Mislabeled or Not in Original Labeled Container

This change has in guidance does not apply to PURELL® Hand Sanitizer, which has adhered to normal FDA regulations.

Bulk hand sanitizer and open refillable dispensers also pose significant risks due to potential for human error and lack of certainty about the product:

• Susceptible to alcohol evaporation, which makes sanitizer less effective.
• Too easy to mix different formulations, which is illegal and risks safety.
• Lack of labeling makes it difficult to track expiration dates and lot numbers. Users are also unsure what they are putting on their skin.

Visit the CDC website for further guidance.

www.cdc.gov/handhygiene/providers/index.html

Refilling a PURELL® branded container – whether a bottle or dispenser refill – with a product that is not PURELL® hand sanitizer is a violation of FDA regulation. Intentional or not, this practice is illegal and can be hazardous to public health.

By doing so, the contents are no longer connected to the original, regulated package and label – including important information like expiration dates, lot codes, drug facts, dosage, and ingredients.

Please watch this video and read our Manufacturer’s Guidance for PURELL® Hand Sanitizer Products for more information.