UPDATE: FDA Drug Registration and Listing - Information Request

Recently, an email from the FDA was sent out in regards to drug listing requirements. The FDA has since retracted that email. 

In summary, if you have not changed what sizes of oxygen cylinders/liquid containers you fill since you submitted your paper drug listing (before 2009 and referred to as form 2657), you are not required to update and submit a drug listing, and are not required to take any action at this time. If you have changed this information, and would like us to complete a drug listing for you, contact us at registration@applied-inc.com.

FAQHappy woman sitting at work on a computer.

What's the difference between a registration and a drug listing? 

A registration is submitted annually, and tells the FDA information about your firm (such as location and contact information). (21 CFR 207.21) A drug listing tells the FDA what type of drug (oxygen) and what containers (cylinders, dewars) you fill. A drug listing only is required to be submitted when you change what type of drug or containers you fill. (21 CFR 207.30)

How do I tell what my company has submitted to the FDA for a drug listing? 

If you told Applied that you had changes, we have submitted a drug listing electronically for you. (We ask this question every year at renewal time.) You can check search for your electronically submitted drug listing here by selecting search by "labeler" and typing in your name.  http://www.accessdata.fda.gov/scripts/cder/ndc/default.cfm   If you have never had any changes since your paper form 2657 was submitted, you should look to your paper files for a copy of the form to see what was submitted. 

I can't find my paper drug listing. I'd just like to submit a drug listing electronically, even though it is not required if I have not had changes. How do I do that?

Applied can submit the drug listing for you.  Email registration@applied-inc.com for more information.

 

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