What is the required ratio of acetaminophen to butalbital to be exempt from controlled substance scheduling?

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In order for a combination product containing acetaminophen and butalbital to be exempt from controlled substance scheduling, it needs to meet specific criteria set by regulatory authorities, including the ratio of acetaminophen to butalbital. The correct ratio of acetaminophen to butalbital that allows for exemption from scheduling is 70 mg of acetaminophen for every 15 mg of butalbital.

This specific ratio ensures that the combination product does not possess the pharmacological characteristics that would make it prone to abuse or dependence, which is a crucial consideration for classification as a controlled substance. Maintaining these limits reflects the regulatory intent to balance the therapeutic use of these medications while minimizing the potential for misuse.

The other ratios provided do not align with the established requirements for exemption and would likely lead to the medication being classified as a controlled substance due to an increased ratio of butalbital, which is the component with more potential for abuse.