Q – Why does my Drug Listing have the “Unapproved Medical Gas” warning statement? How can I remove this statement?
A – Medical gases, like oxygen, have been in use for well over a hundred years…. Even before the creation of the FDA. The FDA has approved many drugs over the years… but the common medical gases were never actually formally approved.
Several years ago, we began to see statements on our medical gas listings that said “unapproved medical gas”. Other safety warnings were also placed on the listings that could have been a concern to consumers.
Just recently, the FDA has established a process to remove these “unapproved” statements and warnings. On January 31, 2014, we conducted an 18-minute teleconference explaining how to remove the “unapproved medical gas” warning statement from your listing. You can get the teleconference handout and sample forms/letter from: http://www.gawda.org/uploadedFiles/Site_Framework/Home_Page/FDA_Medical_Gas_Certification_Compliance_Alert_20140131.pdf
You can also listen to a recording of the consultants teleconference about Medical Gas Certification on the GAWDA home page. You can reach it here: http://www.aws.org/GAWDA/audio/Medical_Gas_Update_20140131.WAV