Popular misconceptions to the contrary notwithstanding, there is no law or regulation (FDA or otherwise) which prohibits the one time or occasional sale of used cpaps from one private individual to another

The good folks of this forum,though well intended and providing a valuable public service, choose not to allow the sale/purchase of used cpaps.

My question for you good folks is this: Does anyone know of a forum or site that does allow such sales and purchases.

I have no insurance and am on a extremely limited income and really need to find such a source.

Thanks you so much and good health to all of you.

Lawyermandotcom@yahoo.com

Have to disagree


First off here is the FDA site put in CPAP FDA

You will get back that it is classed as a class 2 device and section 868.5905

Quote:

[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2004]
[CITE: 21CFR868.5905]
    See Related Information on 868.5905 in CDRH databases



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H - MEDICAL DEVICES

PART 868 -- ANESTHESIOLOGY DEVICES

Subpart F -- Therapeutic Devices
Sec. 868.5905 Noncontinuous ventilator (IPPB).

(a) Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient`s lungs or to assist a patient`s breathing.

(b) Classification. Class II (performance standards).

The FDA says its a prescription item.  


Here are some of the penalties in NY state, each state has similar laws

Quote:

                               ARTICLE 178
             CRIMINAL DIVERSION OF PRESCRIPTION MEDICATIONS
                            AND PRESCRIPTIONS
Section 178.00 Criminal diversion of prescription medications and
                 prescriptions; definitions.
        178.05 Criminal diversion of prescription medications and
                 prescriptions; limitation.
        178.10 Criminal diversion of prescription medications and
                 prescriptions in the fourth degree.
        178.15 Criminal diversion of prescription medications and
                 prescriptions in the third degree.
        178.20 Criminal diversion of prescription medications and
                 prescriptions in the second degree.
        178.25 Criminal diversion of prescription medications and
                 prescriptions in the first degree.

S 178.00 Criminal diversion of prescription medications and
           prescriptions; definitions.
  The following definitions are applicable to this article:
  1. "Prescription medication or device" means any article for which a
prescription is required in order to be lawfully sold, delivered or
distributed by any person authorized by law to engage in the practice of
the profession of pharmacy.
  2. "Prescription" means a direction or authorization by means of a
written prescription form or an oral prescription which permits a person
to lawfully obtain a prescription medication or device from any person
authorized to dispense such prescription medication or device.
  3. "Criminal diversion act" means an act or acts in which a person
knowingly:
  (a) transfers or delivers, in exchange for anything of pecuniary
value, a prescription medication or device with knowledge or reasonable
grounds to know that the recipient has no medical need for it; or
  (b) receives, in exchange for anything of pecuniary value, a
prescription medication or device with knowledge or reasonable grounds
to know that the seller or transferor is not authorized by law to sell
or transfer such prescription medication or device; or
  (c) transfers or delivers a prescription in exchange for anything of
pecuniary value; or
  (d) receives a prescription in exchange for anything of pecuniary
value.

S 178.05 Criminal diversion of prescription medications and
           prescriptions; limitation.
  1. The provisions of this article shall not apply to:
  (a) a duly licensed physician or other person authorized to issue a
prescription acting in good faith in the lawful course of his or her
profession; or
  (b) a duly licensed pharmacist acting in good faith in the lawful
course of the practice of pharmacy; or
  (c) a person acting in good faith seeking treatment for a medical
condition or assisting another person to obtain treatment for a medical
condition.
  2.  No provision of this article relating to the sale of a
prescription medication or device shall be deemed to authorize any act
prohibited by article thirty-three of the public health law or article
two hundred twenty of this chapter.

S 178.10 Criminal diversion of prescription medications and
           prescriptions in the fourth degree.
  A person is guilty of criminal diversion of prescription medications
and prescriptions in the fourth degree when he or she commits a criminal
diversion act.
  Criminal diversion of prescription medications and prescriptions in
the fourth degree is a class A misdemeanor.

S 178.15 Criminal diversion of prescription medications and
           prescriptions in the third degree.
  A person is guilty of criminal diversion of prescription medications
and prescriptions in the third degree when he or she:
  1. commits a criminal diversion act, and the value of the benefit
exchanged is in excess of one thousand dollars; or
  2. commits the crime of criminal diversion of prescription medications
and prescriptions in the fourth degree, and has previously been
convicted of the crime of criminal diversion of prescription medications
and prescriptions in the fourth degree.
  Criminal diversion of prescription medications and prescriptions in
the third degree is a class E felony.

S 178.20 Criminal diversion of prescription medications and
           prescriptions in the second degree.
  A person is guilty of criminal diversion of prescription medications
and prescriptions in the second degree when he or she commits a criminal
diversion act, and the value of the benefit exchanged is in excess of
three thousand dollars.
  Criminal diversion of prescription medications and prescriptions in
the second degree is a class D felony.

S 178.25 Criminal diversion of prescription medications and
           prescriptions in the first degree.
  A person is guilty of criminal diversion of prescription medications
and prescriptions in the first degree when he or she commits a criminal
diversion act, and the value of the benefit exchanged is in excess of
fifty thousand dollars.
  Criminal diversion of prescription medications and prescriptions in
the first degree is a class C felony.

And you could also be leaving yourself open to civil action should the equipment fail or not operate properly after you sell it.  Don't see that risk being worth the couple of hundred bucks you'd get from selling your CPAP.  Better to donate it to a sleep lab, hospital or medical relief agency, who have facilities to insure proper operation of the machine, and who will then see that it gets into the hands of a deserving patient.  You can get a tax write-off and have done a good deed helping others.  And those people who have difficulty getting equipment because of finances should investigate those routes, because you'll probably be able to get the additional equipment and support you'll need, too.
sleepydave

3. "Criminal diversion act" means an act or acts in which a person
knowingly:
  (a) transfers or delivers, in exchange for anything of pecuniary
value, a prescription medication or device with knowledge or reasonable
grounds to know that the recipient has no medical need for it

The way I read it, if the recipient HAS a medical need for the device then the transfer is not criminal.

Ok, got an answer from the FDA.

Quote:

Dear Mike:

After reading this response to your inquiry, please feel free to contact me for clarification.
======================

Please follow the following URL to the "TITLE 21--FOOD AND DRUGS; CHAPTER 9--FEDERAL FOOD, DRUG, AND COSMETIC ACT; SUBCHAPTER III--PROHIBITED ACTS AND PENALTIES" for this part of the information you requested. As to the legal marketing of new and used devices I would rather have a discussion with you. Either provide me your number so I can call you to discuss this topic or call me Friday not between 1:30 & 3:00 at 800.638.2041x122.

======================
 
http://www.access.gpo.gov/uscode/title21/chapter9_subchapteriii_.html
 
======================
Thank you for this opportunity to be of assistance,

Sincerely,

=|<:}Geoff
Mr Geoffrey S Clark, ConsumerSafetyOfficer

HHS/PHS/FDA/CDRH/OCER/DSMICA
Room 130H - (HFZ-220)
1350 Piccard Drive
Rockville, MD - 20850-4307 - United States of America
Email - gsc@cdrh.fda.gov or geoffrey.clark@fda.hhs.gov

It appears to be part of 360j, but I am calling to get the exact reason.  

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.)  So the above law might or might not apply, but the federal one does.

Here is the final word.


The FDA regulates distribution of prescription items.  As long as these 2 things are met, then its 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 are 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.  As the ASAA can not get into the business of verifying either, we will not promote that type of commerce (or any other for that matter) on this forum.  

Hopefully this will put an end to the question.  If not, the contact information for the FDA is listed in the above post.