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In case anyone is still making hand sanitizer - the game is up


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Effective Dec. 31, 2021, companies manufacturing alcohol-based hand sanitizers under the temporary policies must cease production of these products. Hand sanitizers manufactured before or on December 31, 2021, and produced under the temporary guidances, must no longer be sold to wholesalers or retailers by March 31, 2022.   See: 

https://www.fda.gov/news-events/press-announcements/fda-brief-fda-withdrawing-temporary-guidances-alcohol-based-hand-sanitizers .  

 

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On 10/14/2021 at 10:52 AM, dhdunbar said:

Effective Dec. 31, 2021, companies manufacturing alcohol-based hand sanitizers under the temporary policies must cease production of these products. Hand sanitizers manufactured before or on December 31, 2021, and produced under the temporary guidances, must no longer be sold to wholesalers or retailers by March 31, 2022.   See: 

https://www.fda.gov/news-events/press-announcements/fda-brief-fda-withdrawing-temporary-guidances-alcohol-based-hand-sanitizers .  

 

Also , if you were registered , make sure you go into eDRLs and de register your company cause they will try to charge you after the 31st of December.  Here's the portal just in case.

https://direct.fda.gov/apex/f?p=100:LOGIN_DESKTOP:104623642556001

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  • 2 months later...

Bump - Make sure you have deregistered everything by Friday. If you don't know how here's info from the DISCUS. Make sure you do it in the correct order. If you don't you'll have to reregister your establishment. Not a huge deal if you mess it up. 

 

1) The first thing you will want to do is delist the drug product. To do this:

1) Login to the CDER Direct Account (https://direct.fda.gov)

2) Click on “Product Listing and Reporting”

3) Click on “Submission Accepted” for the most recently, previously submitted Product Listing

4) Click on “Create New Version” (do not alter any of the information in the Header Details as it is correctly updated for you when you click “Create New Version”)

5) Click on the edit tool (pencil/notepad) next to the Product NDC toward the bottom of the page

6) Change the Marketing Status from “ACTIVE” to “COMPLETED”

7) Enter an End Marketing Date that corresponds to the last lot expiration date

😎 Click on “Save Product”

9) Click on “Submit SPL”

2) After that submission returns as “Submission Accepted” (takes about 15 minutes), then you may De-Register your establishment. To do this:

 

1) Login to your CDER Direct Account

2) Click on “Establishment Registration”

3) Click on “Submission Accepted” for the most recently submitted Establishment Registration

4) Click on “Create New Version” (do not alter any of the information in the Header Details as it is correctly updated for you when you click “Create New Version”)

5) Change the Document Type to “Establishment De-Registration”

6) Click on “Submit SPL”

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