West Virginia MPJE (Pharmacy Jurisprudence) Practice Exam

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How is codeine classified federally if it is formulated as part of a combo product?

  1. CII

  2. CIII

  3. CIV

  4. CV

The correct answer is: CII

When codeine is formulated as part of a combination product, it is classified federally as a Schedule III substance, but with specific limitations depending on the amount of codeine present in the formulation. In the context of combination products, codeine is regulated under Schedule III if the product contains not more than 1.8 grams of codeine per 100 milliliters or not more than 90 milligrams per dosage unit, with a combination of another non-narcotic ingredient. The classification reflects an understanding of the potential for abuse; Schedule I substances are the most tightly controlled, while Schedule V includes substances with the least potential for abuse. Therefore, combination products with low doses of codeine allow for medicinal use while maintaining regulatory control to reduce the risk of misuse. In the case of this specific question, focusing on combination formulations aligns with their scheduling under federal law, confirming that they fall under Schedule III rather than being classified as a Schedule II, IV, or V substance.