Why Fioricet is not a controlled substance ?

Fioricet contains: 325 mg of acetaminophen (APAP), 50 mg of butalbital, and 40 mg of caffeine.

New capsule reformulation of Fioricet contains: 300 mg of acetaminophen (APAP), 50 mg of butalbital, and 40 mg of caffeine.

Fiorinal contains: 325 mg of aspirin (ASA), 50 mg of butalbital, and 40 mg of caffeine.

The only difference between these two is the aspirin in Fiorinal vs acetaminophen in Fioricet.

The interesting thing is that Fiorinal is a scheduled class III substance, while Fioricet has a non-scheduled status. It seems really strange because both combinations contain equal amount of the controlled substance butalbital.

Two possible reasons:

  1. The aspirin is easier to remove than the Tylenol (APAP).
  2. Due to the protein binding of APAP. From what I can ascertain, since both butalbital and APAP are protein bound, there is more free butalbital in the Fioracet. Butalbital is metabolized to phenobarbital to exert it’s effects, and this metabolite can reach higher concentrations at a faster rate than the Fiorinal can.

I haven’t found legit studies to back this up, but it’s reasonable and it’s what I can find. One other thought is that large doses of APAP are likely more harmful to the average person than large doses of aspirin. Aspirin can increase the risk of bleeding by a significant measure and can reduce kidney function, but APAP can do dangerous to deadly damage to your liver.

Exceptions from the scheduling have been made if the drug meets the requirements of section 811(g) (3) (A) of the Controlled Substances Act. The exemption requires that one of the active ingredients be a non-narcotic controlled substance and one of the others be a non-scheduled compound. The potential for abuse is decreased if a sufficient amount of a non-controlled substance (e.g., aspirin or acetaminophen) is added.

According to the FDA, the issue boils down to a specific ratio of aspirin or acetaminophen to butalbital. Fiorinal® is required to have at least 188 mg of aspirin for every 15 mg of butalbital (188:15) to meet CSA exemption. The ratio needed for Fioricet® is 70 mg of acetaminophen for every 15 mg of butalbital (70:15). These ratios were based on what the FDA believed were adequate amounts of nonnarcotic to reduce the abuse potential of butalbital.

The acetaminophen to butalbital ratio in new and old formulation of Fioricet:

Old formulation:

325 mg Acetaminophen / 50 mg Butalbital

97 mg Acetaminophen to 15 mg Butalbital (To be exempt, ration requires at least 70 mg or more Acetaminophen for every 15 mg Butalbital included in formulation.

New Formulation:

300 mg Acetaminophen / 50 mg Butalbital

90 mg Acetaminophen to 15 mg Butalbital (To be exempt, ration requires at least 70 mg or more Acetaminophen for every 15 mg Butalbital included in formulation.

So both new and old formulation of Fioricet by law shall be exempt from controlled substance requirements.

The aspirin to butalbital ratio in Fiorinal:

325 mg Aspirin / 50 mg Butalbital

97 mg Aspirin to 15 mg Butalbital (To be exempt, ration requires at least 188 mg or more Aspirin for every 15 mg Butalbital included in formulation.

Therefore Fiorinal is classified as a Schedule III substance.

Leave a Comment