Why is fiornal a controlled substance by fiorcet is not?

[Dred Pirate]

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I have always wondered this - was studying for a new states MPJE and one of the test bank questions actually had this wrong - not really important, just doesn't make sense to me.

 

[zelman]

I have always wondered this - was studying for a new states MPJE and one of the test bank questions actually had this wrong - not really important, just doesn't make sense to me.

Fiorocet is a controlled substance in some states. The test may have been right.

But, to answer your question, approval dates. Same as Lyrica v. Neurontin.

 

[WorthlessOxygen]

I have always wondered this - was studying for a new states MPJE and one of the test bank questions actually had this wrong - not really important, just doesn't make sense to me.

I'm sure someone else can explain better than I can but to be exempt from a controlled substance you need an aspirin:butalbital ratio of 188:15 while acetaminophen only needs 70:15. So fiorinal doesn't contain enough aspirin to be exempt but fioricet contains enough APAP.

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[APN-59 rph]

I'm sure someone else can explain better than I can but to be exempt from a controlled substance you need an aspirin:butalbital ratio of 188:15 while acetaminophen only needs 70:15. So fiorinal doesn't contain enough aspirin to be exempt but fioricet contains enough APAP.

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That sounds about what I heard in the hazy past.....I can't remember the last time I touched either one....maybe an ancient bottle with 3 tabs at the bottom

 

[beautifulrobot]

Might be a good question for the FDA historians...

 

[Dred Pirate]

I'm sure someone else can explain better than I can but to be exempt from a controlled substance you need an aspirin:butalbital ratio of 188:15 while acetaminophen only needs 70:15. So fiorinal doesn't contain enough aspirin to be exempt but fioricet contains enough APAP.

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yes - this is the case - I found it - and bye the way - in the state I work- fiorcet is non-controlled, in the state I am taking the MPJE - it is controlled - love taking the MPJE is a new state. lol

 

[Dred Pirate]

google is my friend

Fiorinal is a Schedule III controlled drug but Fioricet is not!

Fiorinal is a Schedule III controlled drug but Fioricet is not!

www.pharmacyexam.com

 

[Rouelle]

All butalbital products are controlled in my state.

 

[Old Timer]

What it boils down to is this. Potential for abuse. You can take loads of ASA and live, but loads of Tylenol can kill you. Same reason Tincture of Opium was C-II and Paregoric (Camphorated Tincture of Opium) was C-III. If you either drank enough or evaporated the alcohol and snorted or ingested the camphor would kill you. Th ratio is not the real answer. The real answer is potential for abuse.

 

[owlegrad]

All butalbital products are controlled in my state.

Funny you say this. FL statute says all butalbital products are controlled substances BUT our wholesalers do not consider it a control and the pharmacy I work at now is the only one I have ever worked at that treated it like a control. Also in school they taught us for MPJE purposes that it is not a control.

I am actually curious if anyone else in Florida treats it like a control?

 

[WorthlessOxygen]

That sounds about what I heard in the hazy past.....I can't remember the last time I touched either one....maybe an ancient bottle with 3 tabs at the bottom

Weird... I dispense it at least 2-3 times per week. Not exactly a fast mover but relatively popular

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[Wickett]

Funny you say this. FL statute says all butalbital products are controlled substances BUT our wholesalers do not consider it a control and the pharmacy I work at now is the only one I have ever worked at that treated it like a control. Also in school they taught us for MPJE purposes that it is not a control.

I am actually curious if anyone else in Florida treats it like a control?

In Texas, but fioricet is also not legally a control. I always treated it like a control (double counting, only fill a couple days early, etc). I've had patients display red flag/addictive behavior with it, so I treat it like a controlled substance. I also treat gabapentin similarly.

 

[Dred Pirate]

What it boils down to is this. Potential for abuse. You can take loads of ASA and live, but loads of Tylenol can kill you. Same reason Tincture of Opium was C-II and Paregoric (Camphorated Tincture of Opium) was C-III. If you either drank enough or evaporated the alcohol and snorted or ingested the camphor would kill you. Th ratio is not the real answer. The real answer is potential for abuse.

From a legal perspective it is the ratio - I have found several sources that support this. IF we based what is a controlled substance based on what can kill you - all paralytics would be controlled - they aren't. Insulin would be a controlled substance - it isn't. Heck - potassium would be a controlled substance - it isn't. Yes - it is based on potential for abuse - but the ratio (at least in the eyes of the DEA) is what makes it a controlled substance.

EDIT: I misinterpreted your post - I thought you said since a product was more deadly - it should be controlled - but I see what you are saying now.

 

[Dred Pirate]

Weird... I dispense it at least 2-3 times per week. Not exactly a fast mover but relatively popular

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we use it in the hospital all the time - and we sub fiornal to fiorcet to avoid the paperwork

 

[Sine Cura]

The "logic" with ASA vs APAP is that APAP toxicity puts limits on the abuse of opioids or butalbital, thus why single-ingredient codeine is CII vs codeine/APAP being CIII.

In California (where butalbital-containing products are CIII) when we order from McKesson, sometimes we get a federally unscheduled butalbital product put on a "state regulated controlled substance" invoice (and no copy), and other times it is lumped in with the other unscheduled products. It's rando. Walmart being a sclerotic, fake-compliance company assigns a non-controlled Rx number so technically you're violating California regulations by filing butalbital scripts with the non-controls.

 

[lord999]

Might be a good question for the FDA historians...

Those union defectives? You know from working there what the purpose of that office actually is. The internet answer is a backporting, but not quite the full explanation.

Fiorinal (old Optalidon) was one of the drugs that predates FD&C (it's something like a 1912 drug and was a DESI) and is one of the drugs that was controlled by statute (NOT by regulation like almost all other drugs in CSA 1970) by the Harrison Act. This one, cocaine, morphine, heroin, marijuana, all of those drugs inherit their classification from Harrison, and a relevant sidebar, this comes into play if marijuana wants to be descheduled. The Attorney General/Secretary of HHS cannot do this with the President's consent, it would have to be a law.

When Fioricet was up in the late 1960s, Sandoz marketed the hell of a pre-marketing study that APAP prevented it from being habit forming due to the liver failure risk. This is the same panel that approved Lortab and Vicodin with the same logic. Sandoz could not get Fiorinal rescheduled, because they could lobby the panel but did not want to spend the resources to lobby Congress.

Also, about the rename of Optalidon to Fiorinal, also marketing due to the anti-German sentiment in the post-war:

https://www.washingtonpost.com/archive/lifestyle/wellness/1988/01/19/whats-in-a-name/98fbc888-6656-4d8b-9fec-b8457cc11023/

Does the MPJE no longer require that Harrison drugs be memorized as they are usual exceptions? I know that Ryan Haight changed the provisions about scheduling, but that used to be a thing.

 

[WorthlessOxygen]

Am I the only one that only ever understands about 1/4 of what Lord is talking about in his posts? Always ends up being the most interesting thing I learn that day though

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[Old Timer]

Am I the only one that only ever understands about 1/4 of what Lord is talking about in his posts? Always ends up being the most interesting thing I learn that day though

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No, becuase he says a lot of things that are true, but unrelated and it's usually nonsensical

 

[Rouelle]

Am I the only one that only ever understands about 1/4 of what Lord is talking about in his posts? Always ends up being the most interesting thing I learn that day though

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He’s probably my favorite poster on here.

 

[lord999]

No, becuase he says a lot of things that are true, but unrelated and it's usually nonsensical

I always have had a really bad habit about being elliptical in my answers (as well as making parenthetical comments to multiple audiences). The older I get and the longer I work a government job, the worse my logorrhea and tangentialism gets as it's shared by most of us in the senior service. I would actually contest the nonsensical nature, but the amount of thought needed to make sense of it really is on me to be more explicit about it and connect the dots more forcefully.

The posts about government and academia though, I make it a point to be vague as I also know who reads this board from those constituencies. It's for them I write some of my most elliptical comments.

It's actually chilling reading what I wrote in 2002 and how those answers changed for the last 18 years. Pretty much I read it now as a protagonist journey to villain. I figure that I'll have my time soon enough.

 

[Old Timer]

I always have had a really bad habit about being elliptical in my answers (as well as making parenthetical comments to multiple audiences). The older I get and the longer I work a government job, the worse my logorrhea and tangentialism gets as it's shared by most of us in the senior service. I would actually contest the nonsensical nature, but the amount of thought needed to make sense of it really is on me to be more explicit about it and connect the dots more forcefully.

The posts about government and academia though, I make it a point to be vague as I also know who reads this board from those constituencies. It's for them I write some of my most elliptical comments.

It's actually chilling reading what I wrote in 2002 and how those answers changed for the last 18 years. Pretty much I read it now as a protagonist journey to villain. I figure that I'll have my time soon enough.

Maybe, but the Harrison Act has nothing at all to do with the Controlled Substances Act. a

 

[Dred Pirate]

Does the MPJE no longer require that Harrison drugs be memorized as they are usual exceptions? I know that Ryan Haight changed the provisions about scheduling, but that used to be a thing.

I have taken the MPJE in 3 different states and have never heard of the harrison drugs - am I the only one?

 

[owlegrad]

I have taken the MPJE in 3 different states and have never heard of the harrison drugs - am I the only one?

I vaguely recall learning about DESI in school but it's been too long to recall the specifics.

 

[WorthlessOxygen]

I vaguely recall learning about DESI in school but it's been too long to recall the specifics.

I definitely learned about DESI drugs but wasn't that related to Kefauver-Harris? This is definitely my first time hearing of Harrison

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[Old Timer]

I definitely learned about DESI drugs but wasn't that related to Kefauver-Harris? This is definitely my first time hearing of Harrison

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Correct. Basically, in 1938 or so some drug company thought ethylene glycol would be an excellent ingredient in Sulfanilamide. Once several people were killed, Congress sprung into action and passed a law that drugs had to be safe. It wasn't until Kefauver-Harris that congress mandated drugs had to be effective as well. All drugs on the market were grandfathered in until they could prove their effectiveness. This period was called Drug Efficacy Study Implementation. The acronym DESI was used to describe all drugs marketed between 1938 and 1962 whose safety was proved, but not it's efficacy. As of now, according to the FDA, the following drugs are still DESI drugs:

(Part of) DESI 597	Anticholinergic/Barbiturate Combinations (Donnatal)	FDA-1975-N-0336 (formerly 79N-0184)
(Part of) DESI 597	Anticholinergic/Barbiturate Combinations Donnatal Extentabs	FDA-1975-N-0337 (formerly 75N-0223)
(Part of) DESI 1786	Pentaerythritol Tetranitrate (PETN) Peritrate	FDA-1987-N-0054 (formerly 87N-0262)
(Part of) DESI 1786	Oral Nitroglycerine, Extended Release Nitro-Bid	FDA-1977-N-0356 (formerly 75N-0240)
DESI 5378	Amphetamines	FDA-1979-N-0328 (formerly 79N-0190)
DESI 6403	Peripheral Vasodilators, Vasodilan (Isoxsuprine)	FDA-1984-N-0259 (formerly 84N-0167)
DESI 7661	Estrogen-Androgen Fixed-Combination Drug Products; Syntest D.S. and Syntest H.S. tablets	FDA-1998-P-0083 (formerly 76N-0377)
DESI 7663	Potassium Aminobenzoate Oral Preparations; Potaba	FDA-1977-N-0015 (formerly 77N-0187)
DESI 8076	Benzocaine, Butyl Aminobenzoate (Butamben), and Tetracaine Hydrochloride Fixed Combination Drug Product; Cetacaine	FDA-1975-N-0338 (formerly 75N-0203)
DESI 10367	Iodochlorhydroxyquin and Hydrocortisone, Vioform HC	FDA-1980-N-0038 (formerly 80N-0012)
DESI 10837	Oral Prescription Drugs Containing an Anticholinergic or Antispasmodic in Combination with a Sedative. And Single-Entity Antispasmodic Drug Products, in Oral Dosage Form	FDA-1975-N-0336 (formerly 75N-0184)