FDA Withdrawing Temporary Guidances for Alcohol-Based Hand Sanitizers
The U.S. Food and Drug Administration (FDA) announced on October 12, 2021, that it intends to withdraw guidances initially issued in March 2020. The guidance outlined temporary policies for manufacturers that were not drug manufacturers to produce alcohol-based hand sanitizer during the public health emergency.
Effective December 31, 2021, companies manufacturing alcohol-based hand sanitizers under temporary policies must cease the production of these products. Moreover, hand sanitizers manufactured before or on December 31, 2021, and produced under the temporary guidances can no longer be sold or distributed by manufacturers after March 31, 2022.
So what does all of this mean for manufacturers, retailers, distributors, and consumers? The Safetec team is here to answer those questions.
Why is the FDA withdrawing these guidances now?
The FDA issued the guidance to help meet the demand for alcohol-based hand sanitizer during the COVID-19 public health emergency through temporary regulatory flexibility. The FDA is withdrawing these guidance documents because current data indicate that consumers and health care professionals are no longer experiencing difficulties accessing alcohol-based hand sanitizer products. Therefore, these temporary policies are no longer needed to help meet demand.
What does a manufacturer need to do to continue manufacturing alcohol-based hand sanitizer products?
After December 31, 2021, manufacturers wishing to continue producing hand sanitizer can do so without an approved new drug application provided they comply with the tentative final monograph for over-the-counter topical antiseptics, as amended. Other applicable requirements, including the FDA’s Current Good Manufacturing Practice requirements, assure that the drug has the ingredients, strength, and quality it claims to have.
How do I know if the hand sanitizer I have has been produced under temporary guidance?
Unfortunately, it is not always evident whether a hand sanitizer product has been produced under the FDA’s temporary policies as outlined in the hand sanitizer guidances. If you have further questions about a specific product, contact the manufacturer or distributor of the product.
Are retailers expected to begin removing any hand sanitizer produced under the temporary guidance from store shelves or online marketplaces?
No. Even after April 1, 2022, retailers may continue to sell their hand sanitizer stock produced under the guidance as withdrawing the guidance is not a requirement to recall all hand sanitizer produced under the temporary policies.
What steps should they take if manufacturers still have undistributed hand sanitizer produced under the temporary guidance after March 31, 2022?
If, after March 31, 2022, manufacturers still have undistributed hand sanitizer prepared under the temporary policies (products produced on or before December 31, 2021), manufacturers should destroy these products. After March 31, 2022, only hand sanitizer products prepared in compliance with all applicable requirements, including the tentative final monograph for over-the-counter topical antiseptics, as amended, should be distributed.
Made in America, for America
All Safetec hand hygiene products are not part of the temporary guidance and have always been regulated and compliant with the FDA’s long-standing requirements.
As a U.S. infection control, first aid & OTC manufacturer, we have been dedicated to leading the fight against preventable infections and cross-contamination for nearly 30 years. Driven by our firm commitment to high-quality products, we manufacture EPA-registered and over-the-counter (OTC) products in our FDA-regulated facility. With our shared vision of protecting people, we offer the very best value in complete product solutions to keep you, your employees, patients, and communities safe.
Safetec has inventory, production capacity, and fulfillment capabilities in place to sustain increased production of our line of Instant Hand Sanitizer gel and spray, surface disinfectants, SaniZide Pro 1 and SaniZide Plus spray and wipes and SaniWash® Antimicrobial Hand Soap.
View our line of Pandemic Control products HERE.