1. Why is FDA withdrawing these guidances now?  

ANSWER: The guidances were issued to help meet the demand for alcohol-based hand sanitizer during the COVID-19 public health emergency through temporary regulatory flexibility for products that met certain important circumstances regarding their formulation and labelling.  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, and these temporary policies are no longer needed to help meet demand. After December 31, 2021, businesses wishing to continue producing hand sanitizer can do as long as they comply with all applicable regulatory requirements.

2. Are companies required to deregister and delist their hand sanitizer products if they are no longer manufacturing the products?  

ANSWER: FDA asks manufacturers to deregister their establishment if they are no longer producing drug products by following the instructions on the Electronic Drug Registration and Listing Instructions page. 

If a registrant used the CDER Direct application, which is one of FDA’s applications for creating and submitting registration and listing, deregister by: 

• open the previously accepted version of the registration file,  
• click “Create New Version,” 
• select “Establishment De-Registration” for the document type, click “Submit SPL.” 

If a manufacturer is no longer producing hand sanitizer but is continuing to produce other drugs and would like to remain registered, they can renew their registration and drug listing for the other products and just delist the hand sanitizer products. Further information on delisting hand sanitizers can be found in the October Federal Register notice.

To delist a product using CDER Direct:

• Log into your account and open the previously accepted version of drug listing submission.
• Click on CREATE NEW VERSION. This will create a copy of the file, keeping the same SetID, but generate a new RootID, Version Number, and Effective date.
• Click on the product to edit the Product Data Elements. Change the Marketing Status from “ACTIVE” to “COMPLETED” and enter a Marketing End Date no later than March 31, 2022.
• Save changes and click SUBMIT SPL.

To delist a product from other software applications:

• Open the previously accepted version of drug listing submission.
• Create a new version with the same SetID from your previous submission, but generate a new RootID.
• Enter the appropriate effective date and version number (generally, one number higher than the previous submission)./li>
• Edit the product data elements. Change the Marketing Status from “ACTIVE” to “COMPLETED” and enter a Marketing End Date no later than March 31, 2022.
• Save and Submit.

To request additional assistance with deregistration and delisting, please contact [email protected]

3. What does a manufacturer need to do to continue manufacturing alcohol-based hand sanitizer products as an over-the-counter drug product? 

ANSWER: 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, and other applicable requirements, including FDA’s Current Good Manufacturing Practice requirements, to assure that the a drug has the ingredients, strength, and quality it claims to have. 

Additional Information 

Current Good Manufacturing Practice (CGMP) Regulations
CDER Webinars:

Monograph reform is here! Learn what to expect and how to prepare
OTC Monograph Reform in the CARES Act: Safety Orders - January 27, 2021

CDER Learn course: Bringing an Over-the-Counter (OTC) Drug to Market for general, pre-OMUFA information on navigating the rules and regulations on bringing an OTC drug to market and the associated FDA processes 

 

4. Does the withdrawal of these guidances mean the exemption from OMUFA fees for hand sanitizer manufacturers registering during the COVID-19 public health emergency are no longer in effect?

ANSWER: Withdrawal of these guidance documents will not cause an assessment of Over-the-Counter Monograph Drug user fees (OMUFA) on manufacturers of over-the-counter (OTC) hand sanitizer.

OMUFA fees are distinct from these guidances and are addressed in FDA’s March 26, 2021 Federal Register notice (86 FR 16223), entitled “Fee Rates Under the Over-the-Counter Monograph Drug User Fee Program for Fiscal Year 2021.” As this Federal Register notice generally explains, FDA will not assess OMUFA facility fees upon those firms that:

a) first registered with FDA on or after the January 27, 2020 declaration of the COVID-19 public health emergency, and
b) whose sole activity with respect to OTC monograph drugs during the pandemic consists of manufacturing hand sanitizers.

Additional information is available in FDA’s March 26, 2021 Federal Register notice and the Health and Human Services Federal Register notice of January 12, 2021 (86 FR 2420).

5. Are retailers expected to begin removing any hand sanitizer produced under the temporary guidance from store shelves or online marketplaces?  

ANSWER:  No. Even after April 1, 2022, retailers may continue to sell their stock of hand sanitizer produced under the guidances. Withdrawing the guidances is not a requirement to recall all hand sanitizer produced under the temporary policies. The withdrawal notice explains that producers that had been producing hand sanitizers under the temporary policies must stop making new hand sanitizer on December 31, 2021, and they must stop distribution of any remaining hand sanitizer products produced under the guidances by March 31, 2022.

6. How do I know if the hand sanitizer I have has been produced under these temporary guidances?

ANSWER: Often, it is not 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.

7. If manufacturers still have undistributed hand sanitizer produced under the temporary guidances after March 31, 2022, what steps should they take?

ANSWER: If, after March 31, 2022, manufacturers still have undistributed hand sanitizer that was 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. Manufacturers should maintain records with information concerning a returned drug product’s destruction, including the product name, manufacturer, lot number, quantity, disposition date, and disposition method. Contact the Environmental Protection Agency and your local waste management and recycling center for information on safe disposal.

8. How should manufacturers dispose of alcohol/isopropyl alcohol after December 31, 2021, that will no longer be used to produce hand sanitizer under the temporary guidances? 

ANSWER:  While hand sanitizers are regulated by FDA as over-the-counter (OTC) drug products, disposal of hazardous waste, including flammable liquids such as alcohol, is regulated by the Environmental Protection Agency and local waste management authorities. We recommend contacting your local waste management and recycling center for more information on hazardous waste disposal.

9. Once the guidance documents are withdrawn on 12/31/21, what manufacturing operations must be complete by 12/31? What about after 12/31?

ANSWER: Any manufacturing operation of hand sanitizer under the temporary policies must end by 12/31/21. This includes not only preparation of the hand sanitizer product, but also repackaging, and relabeling of these hand sanitizer products. For instance, a 55-gallon drum of hand sanitizer made on 12/30/21 under the temporary policies, might be transferred into individual consumer containers on 12/31/21, as well as relabeled, but such repackaging and relabeling may not occur on or after 1/1/22. While these manufacturing operations must cease by 12/31/21, FDA does not intend to object to distribution by the manufacturer, repackager and/or relabeler of these hand sanitizer products prior to 3/31/22.

10. My firm sells hand sanitizer to wholesalers, retailers and in the healthcare market. Can I continue selling my product after March 31, 2022?

ANSWER: Hand sanitizers manufactured before or on December 31, 2021, and produced under the temporary policies must not be sold or distributed by manufacturers after March 31, 2022. This includes distribution to wholesalers, retailers, and hospitals. 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, may be distributed by manufacturers.