What is required on an oxygen drug product label?

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. Each agency is a different government entity that has its own requirements.

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. 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. 

To learn more about the requirements, check out the video below. 

Why do I need to update my labels?
OSHA has adopted a set of standards known as GHS, or Globally Harmonized System of Classification of Labeling of Chemicals.  GHS created a universal system of standardized pictograms and the hazards associated with each chemical.  The new labels have updated warnings and use the pictograms prescribed by OSHA. This update will meet the new OSHA standards. The new updates satisfy the OSHA standards, and do not effect the FDA or DOT requirements. 

Who requires these updated labels?
The OSHA requires the oxygen products labels to conform to these GHS standards.

What do the new labels look like?
The new labels will remain the same size and shape as our previous green colored labels, and our liquid labels.  They will include the yellow Oxidizer symbol, as well as the Gas Cylinder: Gases Under Pressure pictogram.  A size and content chart will be at the center right, and your custom contact information will be centered at the bottom, all over a white background.

Where can I get my new labels?
You may place your order via phone, fax, or online with us for your new compliant labels.

When do I need my labels by? Do I have to remove all my current labels?
There is a rolling change on the labels, so you do not have to immediately strip off your old ones.  The new OSHA compliant labels must be updated by June 1, 2015.  Beginning January, 2014, Applied will be offering the labels so you can begin to get your stock ready in time for the change mid-2015.

I have my labels under the clear coat of the cylinder. Can I place these compliant labels on top of the ones under the clear coat?
No. The FDA does not allow “label stacking”- which is placing a label on top of a label. You’ll need to have those cylinders replaced or refurbished by the due date in 2015.

Are there any more changes coming down the road?
Yes. There could be. The FDA recently passed the Medical Gas Safety Act, and we expect to see some changes in their requirements- however, there is no date set and it could be years. Labels can be updated at any time due to DOT, FDA or OSHA requirements. Applied watches all of these agencies and updates our labels when needed.