Are you confused about FDA registration?  Don’t be!  Applied takes the worry out of annual registration for you!

The FDA says 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. 

Your transfilling site address must match the address on file with Dun and Bradstreet, so be sure to check your DUNS number.

If you are filling different cylinder sizes since the last time you registered, your drug listing should be updated. 

If you are no longer filling at a specific location, it is recommended that you remove the location from the FDA database as well.

Starting June 1, 2009 the FDA stopped receiving paper submissions for registration. Registration must now be done electronically.  Setting up the electronic system may be confusing the first time, but the good news is that we can do it for you! Click here for more information on Applied's FDA registration.