West Virginia MPJE (Pharmacy Jurisprudence) Practice Exam

How is codeine classified federally if it is formulated as a single agent?

1. CII

2. CIII

3. CIV

4. CV

The correct answer is: CII

Codeine, when formulated as a single agent, is classified federally as a Schedule II controlled substance. This classification reflects the significant potential for abuse and the risk of severe psychological or physical dependence associated with codeine when used independently, as it is an opioid analgesic. Single-agent formulations of codeine are considered to have high potency and a strong risk for misuse, which necessitates tighter regulations and controls under federal law. This classification is distinct from combination products containing codeine, which can often be classified as Schedule III or Schedule V, depending on the amount of codeine and other ingredients. Therefore, the rationale behind the classification of codeine as a Schedule II substance is closely tied to its potential for abuse and the necessity for careful monitoring during its dispensing and use in clinical practice.