Why Fioricet is not Controlled Substance but Fiorinal is a Controlled Substance

Fioricet contains: 325 mg of acetaminophen (APAP), 50 mg of butalbital, and 40 mg of caffeine.  The max dose of acetaminophen per day is 4000 mg, and since there’s only 325 mg in Fioricet, you’ll have to take a lot at once or take them for a long time to get the damage from acetaminophen, whereas someone on warfarin takes aspirin and isn’t aware of it the effects could be immediate….The fatal liver damage from acetaminophen comes when you take it with alcohol, so if you don’t take your Fioricet with a shot you should be ok at this dose


Fiorinal contains: 325 mg of aspirin (ASA), 50 mg of butalbital, and 40 mg of caffeine.  Fiorinal is scheduled because drug abusers can easily perform an “acid wash” to remove the aspirin (acetylsalicylic acid) component. It is much more difficult to remove the acetaminophen component in Fioricet. 

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.

Exceptions from the scheduling have been made if the drug meets the requirements of section 811(g) (3) (A) of the Controlled Substances Act2. 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 acetaminophenn) is added. The ratio required for exemption is 70 mg of acetaminophen to 15 mg of butalbital. In contrast, the ratio of aspirin to butalbital is 188 mg to 15 mg.

The acetaminophen to butalbital ratio is approximately 97 mg to 15 mg in Fioricet, thus it is exempt from scheduling1. In Fiorinal the aspirin to butalbital ratio is approximately 97 mg to 15 mg, which is less than the 188mg:15mg ratio, so it is classified as a Schedule III substance.

Citation: Section 811(g)(3)(A) Controlled Substances Act

**Please note: Under the following states law, Fioricet is classified as a Schedule III controlled drug. **

  1. Georgia
  2. Maryland
  3. New Mexico

 Alabama Pharmacy State Board Newsletter that gives somewhat of an explanation:

In the past, there has been confusion over the controlled status of Fioricet. Fioricet is not scheduled federally. In 1980, a federal panel set forth criteria to except certain compounds if they were combined with butalbital and fell within the proper ratio of acetaminophen and butalbital. Fioricet met the criteria to be an excepted compound and was excepted in 1980.

Fiorinal is a much older drug than Fioricet and was released at a time when all butalbital-containing drugs were listed as Schedule-III. Butalbital was later removed from that listing but brand name Fiorinal was never taken off of the list. Fioricet came along after butalbital was removed from the list and it therefore carries no control status. However, butalbital does still carry some danger of dependence and there is no difference in the dependence levels between butalbital with aspirin and butalbital with acetaminophen.