A pharmacist receives a new prescription to compound each capsule such a way so that it contains 200mg Acetaminophen, 50mg Butalbital and 40mg Caffeine. The final formulation of this compounded prescription shall be classified as:
a. Schedule III controlled drug
b. Schedule IV controlled drug
c. Schedule V controlled drug
d. Non-controlled substance
Answer (a): Schedule III controlled drug, [Section 811(g)(3)(A) Controlled Substances Act].
To be exempt from controlled substance requirement, the ratio of Acetaminophen to Butalbital is set to 70:15. In other words, for every 15mg Butalbital, there shall be at least 70 mg or more Acetaminophen required to exempt the formulation from controlled substance requirement.
In above prescription, the quantity of Butalbital is 50 mg; to exempt it from controlled substance requirement, we need to mix it with at least 233 mg or more Acetaminophen. The prescriber has requested Acetaminophen quantity to be set to 200mg; therefore the final formulation shall be classified as Schedule III controlled substance.
**Please note: Butalbital is classified as Schedule III controlled drug under the DEA. **
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