Rhode Island Multistate Pharmacy Jurisprudence (MPJE) Practice Exam

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For Schedule III, what is the upper limit of opium allowed per 100 ml/mg?

  1. 50 mg

  2. 100 mg

  3. 500 mg

  4. 300 mg

The correct answer is: 500 mg

In Schedule III controlled substances, regulations specifically outline the maximum allowable concentration of opium. The upper limit set for opium in a formulation is indeed 500 mg per 100 ml or per 100 grams. This limit applies to preparations that may contain a combination of opium with other ingredients, allowing for certain over-the-counter medications that contain opium derivatives, as long as they comply with this regulation. This distinction is important within pharmacology and law because it differentiates between substances that can be appropriately prescribed or sold by pharmacies and those that are highly regulated. For instance, options like 50 mg, 100 mg, and 300 mg fall below the established threshold for Schedule III, making them inappropriate as the upper limit of opium allowed. Understanding these regulations helps pharmacists ensure compliance with state and federal laws governing controlled substances.