Oxygen Labels 101

What Is Required? And By Who?

Oxygen drug product labels are governed by 3 different agencies. The FDA because it's a drug product, and the DOT and OSHA because it is considered a Hazardous Material that is in transport (DOT) and in the workplace (OSHA). Each agency is a different government entity that has its own requirements.

DOT:

For example, the oxygen diamond and the proper shipping name (Oxygen, Compressed) appearing on the label is for the benefit of the DOT: They want to make sure that the hazardous material is properly identified during transport in the event of an accident so that first responders can react accordingly.

FDA:

The FDA wants the label to indicate what the drug product is (Oxygen) so patients and caregivers know what they are administering to people. So while the DOT would mandate Oxygen, Compressed, the FDA does not care that it is the proper shipping name —just that it properly conveys the identity of the drug product.

OSHA:

OSHA requires certain pictograms and warnings so that workers who come into contact with the oxygen know how to properly handle it in the workplace.

To learn more about the requirements, check out the video at:
http://applied-inc.com/oxygen-drug-product-label-faq

FDA & DOT: Upcoming Changes

FDA requires the name of the manufacturer on the label and their principal place of business. Distributors can have their name on the label, but must have the qualifier "Distributed by" placed on the label. Also, the FDA requires "Rx Only" on the label, among a few other things.

The DOT requires the proper shipping name, oxygen diamond and fine print that is listed in CGA C-7. Due to the new OSHA changes, many in the industry expect the FDA and DOT to update their requirements by 2015 as well.