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. (See 21 CFR 207.21)

 

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

3. Relax!

 

We deal with computer setup, data entry and send it to the Gateway. We also remind you to re-register next year. Your registration will be processedwithin 7-10 business days of receiving your completed paperwork.