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FDA Electronic Registration for New Transfillers

Item # OF-101 NEW

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 1...

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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).

Starting June 1, 2009 the FDA stopped receiving paper submissions for registration. Registration must now be done electronically. (You can see the final guidance here and learn more here.) Setting up the electronic system may be confusing the first time, but the good news is that we can do it for you!

 

Simply:

1. Order the OF-101

2. Fill out Applied's one page paper form under the documents tab.

 

 

Fill out the form below and return it to Applied via fax or email to get started:

Applied's FDA Registration Form

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