Hi, and thanks for the question.
The FDA is your primary "Need to Adhere To" group. States will always
follow and help enforce, or in most cases, just stay out of the way
of, the FDA.
The Federal Food, Drug, and Cosmetic Act requires that facilities that
fill prescription drug oxygen tanks or canisters register with FDA and
that these facilities be subject to agency inspections, to ensure
compliance with current good manufacturing practice. (GMP). Written
SOP's and Labeling standards are also required.
The FDA has a huge web page and its very searchable. (They use Google
as the site search engine) They have all of the forms and the steps to
do what it is you are wanting to do, with several phone numbers and
help programs.
Links of Interest
FDA Home Page
[ http://www.fda.gov/ ]
Title 21. Code of Federal Regulations Cosmetic Products
http://www.cfsan.fda.gov/~dms/cos-cfr.html
FDA Public Advisory
[ http://www.fda.gov/cdrh/oxyreg.html ]
ILLEGAL OXYGEN TRANSFILLING OPERATION PLEADS GUILTY TO FDA ...
[ http://www.fda.gov/bbs/topics/ANSWERS/ANS01013.html ]
FDA Lets Air Out of Medical Gas Company
[ http://www.fda.gov/fdac/departs/2000/500_irs.html ]
Recommended Search
First go to the FDA website, and use their search engine, which is
Google as well
+"Oxygen Tanks"
If you need further help please use the Clarification option to let me
know.
webadept-ga |
Clarification of Answer by
webadept-ga
on
28 May 2002 12:51 PDT
Just a note. I thought the word "prescription" might throw you off, so
I thought I would clarify that. The act is also the "Cosmetic Act"
which basically covers everything else as well. If its Oxygen and in a
tank and someone is going to inhale it, then the FDA wants to know
about it beforhand.
You can read about that in the act that they have on line, which is
one of the hyper links I gave you before.
thanks again.
webadept
|
Request for Answer Clarification by
mikew-ga
on
28 May 2002 21:02 PDT
While the answer given did have some useful info,
it did not hit exactly on what I wanted to know,
so let me re-phrase the question more specifically.
I see that many web sites say that they will only
sell compressed oxygen to people who have
a doctor's prescription. However, take a look at:
http://www.betterthanair.com/products.htm#bta8
This is a product that delivers a mixture of air
that contains 94% oxygen and apparently does not
require a doctor's prescription.
What federal law or FDA reglation states that
a doctor's prescription for oxygen is required?
And does that law or regulation only apply to
oxygen that is of a certain purity (such that
a 94% mixture of oxygen with air is legal
without a prescription)?
|
Clarification of Answer by
webadept-ga
on
28 May 2002 21:49 PDT
Okay, you are right, that's a completly different question. In fact
its nothing like the first question at all. Your first dealt only with
selling oxygen in canisters and this question has to do with selling
oxygen as a drug.
As our commenting friend below (caliprep-ga) states, there are Oxygen
Bars in L.A. and other cities, and I'm very sure there isn't a Dr. in
there handing out perscriptions. So I'll look into it and post another
reply here sometime soon. I just ask, that if it looks like I may not
be on the right track that you post here and set me straight.
Thanks, and check back soon.
|
Clarification of Answer by
webadept-ga
on
28 May 2002 22:38 PDT
Hi Again!
Okay, here's the scoop. Prescription Oxygen is 100% (99.999999999%)
pure oxygen, and you must have a medical license to dispense this
grade, so say a few websites I've looked at, but I've found news
articles which say that the Oxygen Bar they are looking into, uses
95-97% pure oxygen. One has an 11 year old boy using it (in the union
record story below). So, there doesn't appear to be much of a license
or prescription need for pure oxygen.
I am reminded here that once I was given a prescription for a pair of
crutches. This was so my insurance would cover the cost of the
rentals. It could very well be the same with 'prescription oxygen'.
The prescription is merely a formality to the insurance companies, to
show the doctor requested the treatment.
The only FDA regs I found were the same as before and they only apply
to the creation and distribution of the tanks themselves. They appear
to only be concerned that what is on the label is inside the canister,
and I for one am rather happy they are.
Here is a quote from AsiaWeek newspaper in the editors area when asked
about FDA approval on oxygen bars
--
THE FDA'S POSITION: MEDICAL oxygen requires a prescription in order to
be dispensed. But the FDA notes the spread of oxygen bars and says
that they "don't administer oxygen for medical or emergency use in the
traditional sense." Under its rules, oxygen-bar advertising that makes
unproven medical claims would render the oxygen a new drug.
In Asiaweek's article, Oxyvital's owner said her oxygen bar is for the
healthy only and that all customers have to sign disclaimers that they
do not suffer from emphysema or chronic obstructive pulmonary disease.
- Editors
-- link is below
That a company won't sell you Oxygen without a prescription doesn't
appear to have an FDA requirement stopping them. It may just be a
company policy that they only deal with prescription needs.
I hope this answers your revised question.
Links :
[ http://www.oxygenisland.com/oxygen_advantage.htm ]
[ http://www.healthlibrary.com/news/27Nov-2Dec2000/times5.htm ]
[ http://www.unionrecord.com/metro/display.php?ID=1639 ]
[ http://www.asiaweek.com/asiaweek/98/0724/letters.html ]
[ http://www.visionclone.com/breatheinc/getting_started.htm ]
webadept-ga
|
