Rhode Island Multistate Pharmacy Jurisprudence (MPJE) Practice Exam

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What is the minimum required amount of atropine sulfate in a Schedule V compound with diphenoxylate?

10 mcg
20 mcg
25 mcg
30 mcg

The correct answer is: 25 mcg

The minimum required amount of atropine sulfate in a Schedule V compound containing diphenoxylate is established to ensure that the combination is effective in curbing potential abuse while still providing therapeutic benefits. For diphenoxylate to be classified under Schedule V, it must be combined with atropine sulfate in a specific ratio. This combination is intended to deter misuse due to the potential for diphenoxylate, which can induce euphoria. In this case, having a minimum of 25 mcg of atropine sulfate per dosage unit helps to meet regulatory requirements while ensuring that the product is suitable for controlling diarrhea without significant risk of addiction. It acts as an adjunct to diphenoxylate, making the combination less appealing for recreational use due to the unpleasant effects of atropine at higher doses. Other amounts such as 10 mcg, 20 mcg, or 30 mcg do not meet the legal criteria in the state of Rhode Island, as they fall below or above the minimum requirement for a legitimate therapeutic use. Thus, 25 mcg is the minimum amount that aligns with both legal and safety standards surrounding the use of these compounds.