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I am still looking in the STATUTES for specific wording that prevents sale of PAP.

Even the communication from the FDA person is not all that clear and not convincing that he is interpreting it correctly.

He states the requirement for a rx on any legend product and is correct.

Problem is that the wording on PAP and masks(Breeze in my case) is that an ORDER is required.

This is NOT a LEGEND in the sense that penicillin requires.
It states "RX ONLY" or caution: federal(USA) law prevents sale ...........

Incorrect information from the IRS is about 40 pct. The IRS is not responsible for incorrect info.
I would bet the same is true for FDA. Sometimes an urban legend starts this way and all follow it as gospel.

DME are not in any way licensed to dispense prescriptions. Pharmacies are.
DME are authorized to fill ORDERS, not prescriptions, and there is a big difference.

I maintain it is POLICY, not LAW.
I could be wrong, but I think it is fas from settled.IMHO.

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CPAPopedia Keywords Contained In This Post (Click For Definition): DME

It's interesting that we can't sell a cpap unless it is "sold EXACTLY as it is from the manufacturer", but a DME can choose to leave out the manual which means that they certainly aren't selling it "EXACTLY" as it is from the manufacturer.

The simple fact is the device has a legend label (The prescription label) and buying and selling ANYTHING that has a federal legend is illegal without the requisite permissions (i.e. a prescription and someone licensed to "dispense" it. ) FDA regulates distribution of prescription items. As long as these 2 things are met, then it’s ok to buy and sell.

1) The device has to be sold EXACTLY as it is from the manufacturer. No modifications, original packaging must be there. (So if you don't have the manuals/boxes you can not sell it, the reason for this is that the way that you are currently trying to sell it does not match the way that it was Ok’d by the FDA)

2) The purchaser MUST have a VALID prescription. It is a prescription device and as such requires a prescription.


If either of these conditions is not met, then you are in violation of the section listed above.

He did mention that this only is concerning FEDERAL law. Local laws might be more stringent.

So yes you can buy/sell CPAP but only if it is in its original packaging, and the purchaser has a valid prescription. oh and look at your state laws to see who can dispense" it.

For those of you who want to sell your used cpap or biPAP machine, there is a site on the internet that purchases and sells used cpap machines. http://www.secondwindcpap.com (i think that;s it), bought my cpap machine...pretty fair price. Better than sitting in my closet. Mark is the owner, and a respiratory therapist talked to me on the phone for 30 minutes. nice guy. Anyway, thought everyone would like to know how to sell the cpap onlione now that ebay and yahoo don't allow it anymore.

Tim

RedThunder94 wrote:but the law about not selling it second hand is totally unenforceable

It may be difficult to enforce but it is not totally unenforceable. If someone mounts a civil suit related to an event which is claimed to arise from the improper sale of a CPAP device, a criminal proceeding by the state over the sale could well follow (especially if there's some poltical mileage in it).

Cheers,

Bill

I would say something, but you need a prescription to hear it and I'm probably not authorized to dispense the words anyways, so nevermind...

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CPAPopedia Keywords Contained In This Post (Click For Definition): Prescription

scottbla wrote:I would say something, but you need a prescription to hear it and I'm probably not authorized to dispense the words anyways, so nevermind...

ROTFL!! Good one, Scott!