FDA Registration

 

Are you confused about FDA registration?…DON'T BE!

 

 

Applied takes the worry out of annual registration for you!

The FDA states that any firm that transfers oxygen from one container to another, via gas to gas, liquid to gas, or liquid to liquid; is considered a drug manufacturer by the FDA and is required to register with the FDA every year between October 1st and December 31st of the year. (See 21 CFR 207.21(a)).

 

When you are getting ready to register or renew with the FDA, remember these tips:

1. Your transfilling site address must match the address on file with Dun and Bradstreet, so be sure to check your DUNS number.
2. If you are filling different cylinder sizes since the last time you registered, your drug listing should be updated.
3. If you are no longer filling at a specific location, it is recommended that you remove the location from the FDA database.
4. Starting June 1, 2009, the FDA stopped accepting paper submissions for registration. Registration must now be done electronically.

 

Setting up the electronic system may be confusing, but the good news is —
Applied can take the confusion out of it for you!

Existing Registration Renewal:

FDA Electronic Registration Renewal for the upcoming year for those that have previously registered with Applied. Firm's registration will be created and a digital certificate emailed at the time of order, email confirmation of registration. Click here to access our renewal form.

1-Year Renewal  #OF-105 

New Registrants:

Standard Processing - # OF-101

FDA electronic registration for transfillers, includes one drug listing for oxygen if needed. We also remind you to re-register next year. Processed by Applied between October 1st and December 31st of the current year.

Rush Processing - #OF-101 RUSH

Need it in a hurry, try our overnight service! Registration processed by Applied in 24 hours.

Click here to access our renewal form.

For more information, call 888-327-7301 or email us at info@applied-inc.com

 

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