FDA Registration FAQs

Nov 24, 2014

Below is an FDA requirements cheat sheet with our frequently asked questions. If you are still confused, or looking for more answers, Applied can take the hassle away and register for you! Just give us a call for more information, 1-888-327-7301.
 

How do I know if I have to register with the FDA?
Anyone who fills, or private labels the gas MUST register. (21 CFR 207.20)

How often is it required to register?
Registration must be done annually, and it must be submitted between October 1 and December 31 of the year. (21 CFR 207.21(a), 21 USC 360(b))

Should I register before I begin transfilling, or should I wait until my system is operating?
Registration must be done within 5 days of starting filling. (21 CFR 207.21 (a))

Can I register without filling out the drug listing?
Everyone who registers must do a drug listing. (21 CFR 207.21 (a)) You only submit a drug listing, after the initial reporting, if there are updates. (21 CFR 207.30(b))

Why didn't the FDA assign me an FEI number?
The FDA may assign an FEI number to each establishment. If it doesn't, you can use that location's DUNS number.

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