EZdrinking Posted April 29, 2020 Share Posted April 29, 2020 FDA is requiring DSPs that are producing Hand Sanitizer to register here: https://www.fda.gov/drugs/drug-registration-and-listing-system-drls-and-edrls/electronic-drug-registration-and-listing-instructions Link to comment Share on other sites More sharing options...
SteelB Posted May 21, 2020 Share Posted May 21, 2020 whats involved in this process is it a pain in the ass Link to comment Share on other sites More sharing options...
Thatch Posted May 21, 2020 Share Posted May 21, 2020 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. Link to comment Share on other sites More sharing options...
Foreshot Posted May 22, 2020 Share Posted May 22, 2020 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. Link to comment Share on other sites More sharing options...
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