Arizona MPJE (Pharmacy Jurisprudence) Practice Exam

What classification is given to GHB if it is included in an approved drug product?

1. Schedule IV

2. Schedule III

3. Schedule I

4. Schedule II

The correct answer is: Schedule III

When GHB (gamma-hydroxybutyrate) is included in an approved drug product, it is classified as a Schedule III controlled substance. The reason for this classification is based on its medical use, alongside the potential for abuse and dependence. Schedule III substances exhibit a lower potential for abuse compared to those in Schedule I and II, yet can still lead to moderate physical dependence or high psychological dependence. In the context of approved drug products, GHB is sometimes used therapeutically, for example in the treatment of narcolepsy under the brand name Xyrem. The Schedule III classification allows for these legitimate uses while still imposing regulations to control access and prevent misuse. The other schedules denote varying levels of control based on abuse potential and accepted medical use. Schedule I substances have no accepted medical use, while both Schedule II and Schedule IV classifications involve stricter controls than Schedule III. Thus, the classification of GHB in this context effectively balances its medical applications with the need to monitor its use.