May 2, 2017 09:39
7 yrs ago
131 viewers *
English term
sale by/to
English
Medical
Medical (general)
Prescription devices (US English)
My question concerns the exact meaning of the phrase 'Federal law restricts this device to sale by or on the order of a physician'.
If you go to this page on prescription devices on the FDA website, which I suppose is the origin of the phrase:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFR...
and look at (a) (2), it says, about prescription devices:
'Is to be sold only to or on the prescription or other order of such practitioner for use in the course of his professional practice',
while under (b) it says:
'The label of the device, other than surgical instruments, bears:
(1) The statement "Caution: Federal law restricts this device to sale by or on the order of a ____", the blank to be filled with the word "physician", "dentist", "veterinarian"...'
Can anyone explain why the word 'by' is used in (b) (1) and not 'to' as in (a) (2)?
Thank you for you help.
If you go to this page on prescription devices on the FDA website, which I suppose is the origin of the phrase:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFR...
and look at (a) (2), it says, about prescription devices:
'Is to be sold only to or on the prescription or other order of such practitioner for use in the course of his professional practice',
while under (b) it says:
'The label of the device, other than surgical instruments, bears:
(1) The statement "Caution: Federal law restricts this device to sale by or on the order of a ____", the blank to be filled with the word "physician", "dentist", "veterinarian"...'
Can anyone explain why the word 'by' is used in (b) (1) and not 'to' as in (a) (2)?
Thank you for you help.
Responses
1 day 1 hr
Selected
2a covers sales by, to and prescribed, the label omits TO
I do not see the meanings as different. However, the label basically omits one permitted type of sale (TO practitioners).
My reasoning:
As it is clear and stated in both 2a and 2b that these can be sold on prescription, let's look at 2a without the prescription part:
...is to be sold only to such practitioner for use in the course of his professional practice...
It can be argued that selling to patients forms a part, an aspect of the professional practice of a practitioner. It might also be possible that a practitioner can prescribe a product and sell/dispense it too (as it for example vets do here in the UK).
Thus, the 2a provision covers all three: sales to doctors, by doctors, and on prescription.
The label covers two of those. Not conflict but omission.
***
To answer the specific question:
Can anyone explain why the word 'by' is used in (b) and not 'to' as in (a)?
Sales to practitioners are kind of by default sales on prescription - the prescription is implied and perhaps the label just goes to far in avoiding redundancy.
My reasoning:
As it is clear and stated in both 2a and 2b that these can be sold on prescription, let's look at 2a without the prescription part:
...is to be sold only to such practitioner for use in the course of his professional practice...
It can be argued that selling to patients forms a part, an aspect of the professional practice of a practitioner. It might also be possible that a practitioner can prescribe a product and sell/dispense it too (as it for example vets do here in the UK).
Thus, the 2a provision covers all three: sales to doctors, by doctors, and on prescription.
The label covers two of those. Not conflict but omission.
***
To answer the specific question:
Can anyone explain why the word 'by' is used in (b) and not 'to' as in (a)?
Sales to practitioners are kind of by default sales on prescription - the prescription is implied and perhaps the label just goes to far in avoiding redundancy.
4 KudoZ points awarded for this answer.
Comment: "Thank you for your thorough explanation. I am less confused now."
13 hrs
English term (edited):
'Federal law restricts this device to sale by or on the order of a physician\'
parsing + implied text
'Federal law restricts [the sale of] this device to:
a) sale by a physician
or
b) sale on the order of a physician'
IOW you can legally buy this device only directly from a physician, or from anyone else but only on the order of a physician
a) sale by a physician
or
b) sale on the order of a physician'
IOW you can legally buy this device only directly from a physician, or from anyone else but only on the order of a physician
Discussion
I also don't think this regulates who is allowed to USE these devices, but it simply specifies that an authorised practitioner's order/permission is needed for the device to be provided.
''To a practitioner'', ''by a practitioner'' and ''on the order of a practitioner'' are all cases of ''prescription only'' situation, although - when obtained by a practitioner for use by the practitioner - the prescription might be implicit rather than actual.
HOWEVER, there is perhaps just one — very far-fetched! — scenario I can imagine in which it might be correct (though I'm pretty sure it isn't!)
SUPPOSE that the message printed on the label is intended for the end-user patient, who, once they have the device in their sticky mitts, needs to be told that they should only have been sold this BY a medical practitioner etc. — the difference between the warning to the people for whom these things are intended, and the end-user warning on the device itself.
Like I said, personally, I think that's too far fetched and contrived to be viable... but it would provide a rather tenuous grammatical explanation for the difference!
http://www.proz.com/kudoz/English/general_conversation_greet...
I must admit I'm confused too. "By or on the order of" means they can sell or prescribe it, but I'm sure you've worked that out.