Is Oxygen a Drug per FDA?

tehuff

Involved In Discussions
#1
Hi Covers,
Is the supplemental oxygen produced by a portable oxygen concentrator (prescription required) considered a drug? I am trying to determine the software level of concern and one of the questions is whether or not the device is used with a drug. The device filters air and concentrates the oxygen for delivery to patient via a nasal cannula. It is not life supporting. Is the oxygen in this case considered a drug per FDA? The concentrator device is Class II (product code CAW) if that helps-

Anyone worked on something similar?

Thx!
 
Last edited:
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J

Jason PCSwitches

#2
Yes and NO, it depends on the context in which it is used. Great question though, should get a lot of responses. I'm interested to hear others viewpoints. Regardless, the FDA
's definition of a drug makes it clear, somewhat. Again, it's all about the purpose of usage. Breathing oxygen as we all do without assistance is not a drug, but when administered to treat, prevent, or cure a disease and/or aliment as a component of medicine...well it's gray but technically I believe it is then a drug.

BTW, just because or not because a doctor prescribes it does not determine the classification.
 
C

cclee

#3
To give you some idea, oxygen compressed gas cylinders are labeled either with USP (drug gases) or non USP grade (medical device gases: e.g aerobic, lung diffusion, biological atm). The bulk O2 for packaging these gases are also from 2 sources, one USP grade other is industrial high purity grade.

Since oxygen concentrator is used as an alternative to a compressed gas oxygen cyclinder, it will be classified according to the same application I suppose.
 
#4
Looks perfectly clear to me. ;)

Here's a link to the FDA drug directory.

Put in the word 'oxygen' and it will bring up a database of concentrations and mixes. http :// www. accessdata. fda. gov/scripts/cder/ndc/queryndcai.cfm - DEAD 404 LINK UNLINKED
 
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Ajit Basrur

Staff member
Admin
#5
Hi Covers,
Is the supplemental oxygen produced by a portable oxygen concentrator (prescription required) considered a drug? I am trying to determine the software level of concern and one of the questions is whether or not the device is used with a drug. The device filters air and concentrates the oxygen for delivery to patient via a nasal cannula. It is not life supporting. Is the oxygen in this case considered a drug per FDA? The concentrator device is Class II (product code CAW) if that helps-

Anyone worked on something similar?

Thx!
Great question (as Jason mentioned).

Pls refer these FDA links and let us know your answer :)


Import Alert 66-37

CPG Sec. 435.100 Compressed Medical Gases - *Warning Letters for Specific Violations Covering Liquid and Gaseous Oxygen* - DEAD 404 LINK UNLINKED
 
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A

Al Dyer

#6
I use O2, and am on Medicare & Blue Care Advantage. They sure both consider it a drug. O2 at low levels will slowly kill you (<89) Long term use of O2 will also kill you, it rusts the body as it rusts anything it contacts. It's a scary stuff to deal with when needed to live balanced with the amount that will slowly have a detrimental affect on the same condition. I do have some knowledge as I suffer from COPD.

Fell free to contact me

Al..............
 
L

Laura Halper

#7
Yes, the FDA regulates compressed oxygen as a prescription drug, and the production/processing is subject to 21CFR Parts 210 and 211. However, because the nature of oxygen is so "different" from other drugs, it's hard to apply some sections of Part 210/211. So the FDA has issued CGMP Guidance specific for compressed oxygen -- "Compressed Medical Gases Guideline".

Here's a link to the Guidance:
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm124716.htm
 

tehuff

Involved In Discussions
#8
Hi all,
Just wanted to close this thread with the final answer. Oxygen is NOT a drug per FDA in the context of a device that produces concentrated oxygen by filtering ambient air (see original post). The device itself is regulated as a medical device but the oxygen is not considered a drug in this instance. The software level of concern for this type of device is moderate. Thanks!
 
G

Gerry Quinn

#9
This draft document goes a long way to defining the division between and device and a drug.

Guidance for Industry and FDA Staff:
Interpretation of the Term “Chemical Action” in the Definition of Device under Section 201(h) of the Federal Food, Drug, and Cosmetic Act
 
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