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FDA Registration Required for Producing Hand Sanitizer

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  • 3 weeks later...
1 hour ago, SteelB said:

whats involved in this process is it a pain in the ass 

It takes several hours.  The guide is helpful but if you contact their tech support you get a very respectful "read the document" response.  You are registering/applying for 3 things, your establishment, your labeler code and then establishing the NDC number for each size container.  Each step requires a separate approval before you are allowed to move ahead.  You must also be prepared in the final step to upload a copy of your label, both front and back. 

The one piece of advice I can give you is to follow the document.  If you approach this thinking you can "figure it out" you will cause yourself a lot of grief and additional time.  I tried to "figure it out" and wound up starting from the beginning twice.

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The process isn't fun. Basically you follow the document. There's a few parts that aren't super clear but you'll figure it out. The pain part is that you you do a couple things and validate which take a few minutes to a few hours. Then you submit which take a few hours to a few days. You do that many times. I was able to complete in 2-3 days while only half paying attention.

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