Registration Search:
Check your FDA Registration Status Here
Search for your Labeler Code Here at the National Drug Code Directory
FDA:
The US Food and Drug Administration (FDA) regulates the manufacture of all drugs, including oxygen. You can find the the federal law that details the cGMP, Title 21 Chapter I, subchapter C, here.
You can find FDA's guidance for industry, here.
DOT:
The US Department of Transporation (DOT) regulates the transportation of all hazard materials transported in commerce. That means any amount of oxygen transported for sale, aka, delivered to a patient. You can find the federal law that governs transportation, Title 49, Subchapter B here.
If you would like to download one or more of our helpful resources, simply select the ones that interest you and we will send them to you via email.
Get the latest regulatory info, accreditation news and exclusive discounts!