August 23, 2006 - 7:17am
i saw this question pop up on another board and thought it was intersting myslef. wondered if anyone had any good insight on the subject, (i am thinking there is a simple answer)
why plain Fiorinal (butalbital, caffeine, and aspirin) is a C-III while Fioricet (butalbital, caffeine, and acetaminophen) is not even scheduled--at least in most states.???
August 23, 2006 - 2:09pm
#2
i believe that you are
i believe that you are correct. Feds control determining "who's,who's" and yes each state has it on special rxing laws.
i DO know what you mean also by "not believing". although one thing that makes this seem plausible is that anyone can order fioricet on any of these on-line pharms w/out an rx.
all this being said i am confused still.
all thoughts and opinions expressed are those of my own and should not be mistaken for medical advice. i am not a doctor nor a pharmacist. all medical questions should be answered by a licensed pharmacist, doctor, or primary care manager.
August 23, 2006 - 2:30pm
#3
It could be the case that
It could be the case that one is CIII and the other is not. I can find them listed as both. It definately is confusing.
I could be wrong, but in cases like this, I have to rely on the DEA schedule and say just like above that Butalbital is a CIII barbiturate, therefore aspirin or acetaminophen shouldn't matter.
As for the online ordering, who knows about that. It seems that things change daily with those, and regulation is sketchy at best.
Maybe someone else can fill us in with their thoughts on this.
August 24, 2006 - 5:09am
#4
Well, according to the FDA
Well, according to the FDA Fiorinal is a CIII and Firoicet is not. So I put the question to the FDA and will hopefully get a reply. I'll be interested in the reason.
August 24, 2006 - 6:24am
#5
THanks rawoody. that never
THanks rawoody. that never occurred to me (thinking of asking them). so i am glad that i asked:) did they give you a turn around time on questions/answers?
thanks again.
all thoughts and opinions expressed are those of my own and should not be mistaken for medical advice. i am not a doctor nor a pharmacist. all medical questions should be answered by a licensed pharmacist, doctor, or primary care manager.
August 24, 2006 - 7:34pm
#6
THe Reply:
Thank you for writing to the Division of Drug Information in the Center
for Drug Evaluation and Research (CDER).
In the Federal Register Notice that was published on November 7, 1980
(FR, Volume 45, page 74091), the scheduling of the product is based on
the amount of aspirin or acetaminophen in each product. When you
calculate the ratio of amount butalbital vs the amount of acetaminophen
or aspirin, one is scheduled (Fiorinal) and the other one isn't
(Fioricet).
You may obtain the FR from a library that subscribes to these documents
or you provide us with your mailing address, we can send you a copy of
the notice.
Best regards,
Division of Drug Informaiton LL
Center for Drug Evaluation and Research
Food and Drug Administration
Note: The Federal Registery Notice online only goes back to 1994. You would have to go to a Federal Despoistory Library to get the mentioned page. For one near you try this website:
http://www.gpoaccess.gov/fr/index.html
There's a link near the bottom under the Buy a copy
it says: Federal Depository Library
August 24, 2006 - 7:53pm
#7
There is Something Wrong
Thanks, Rawoody. We appreciate your taking the time writing the FDA and posting the reply.
But this is crazy. I am still so confused. And someone is wrong somewhere.
Quote:
When you calculate the ratio of amount butalbital vs the amount of acetaminophen or aspirin, one is scheduled (Fiorinal) and the other one isn't (Fioricet).
What the Federal Register is implying is that Fiorinal is scheduled and Fioricet is not because of the aspirin component?
I am not aware that there are any major problems with small amounts of aspirin.
Please correct me if I'm wrong. I'm only looking at the ingredients of the brand name meds:
Fiorinal contains 325 aspirin, 50 mg butalbital and 40 mg caffeine.
Fioricet contains 325 acetaminophen, 50 mg butalbital and 40 mg caffeine.
What's the difference other than aspirin versus acetaminophen??? Since when is aspirin a dangerous drug?
I think the DEA scheduling is really wrong on this one.
I'm not a pharmacist or a medical doctor. This message is not medical advice nor is it an offer to provide medical advice. All drug identifications should be validated by a licensed MD or pharmacist.
August 24, 2006 - 9:01pm
#8
Quote:I think the DEA
Quote:
I think the DEA scheduling is really wrong on this one.
I couldn't agree more.
Maybe thats what makes this one so confusing.
August 24, 2006 - 9:22pm
#9
Thanks Incognito
Thanks incognito!
I've been puzzling over this ever since phisher posted. I'm so glad I'm not the only person who is confused!
This is a good topic. And the FDA answer is crazy, right?! Or at least I think it is.
Tell us the basis - gee, aspirin is bad and acetminophen is good (in equal dosages) and everything else is the same?
This one is a real puzzle.
I'm not a pharmacist or a medical doctor. This message is not medical advice nor is it an offer to provide medical advice. All drug identifications should be validated by a licensed MD or pharmacist.
August 25, 2006 - 4:22am
#10
WEll, I'm going to see about
WEll, I'm going to see about the page they reference and see what is the hullabaloo.
August 25, 2006 - 6:41am
#11
i couldn't agree more w/ all
i couldn't agree more w/ all posts above.
it seems to me like an answer out of convenience for the the USG.
it definatley doesnt make any sense.
initially if one had 4 times the amount of the barb i wouldnt have even though twice about it. however as mentioned above this answer just doesnt fly/float whatever.
all thoughts and opinions expressed are those of my own and should not be mistaken for medical advice. i am not a doctor nor a pharmacist. all medical questions should be answered by a licensed pharmacist, doctor, or primary care manager.
August 25, 2006 - 2:02pm
#12
THey replied and mailed me
THey replied and mailed me the info. For some reason I have a sneaking suspicion that it has to do with the total amount of APAP or ASA you can take safely take a day times the amount of Butabital total taken a day that determines the scheduling. However, this is just my opinion and will have the actual data in 3 or 4 days.
I guess I wasn't aware of this. And don't know if I believe it, it doesn't make any sense to me.
Butalbital itself is the controlled substance according to the the DEA
Since Butalbital is the part in question, it shouldn't be 'unscheduled' just because of what it is mixed with.
I would understand if it were mixed with something else and the fiorinal/fioricet were CIII and the new combo were CII. Sort of like a Hydrocodone combo being CIII unless it contains more than 15mg Hydrocodone or less than 80mg APAP then it becomes CII. Going up makes sense, but not being bumped down.
On another note, aren't controlled substances determined at the Federal level, while prescribing laws regulated by the states?