Wisconsin MPJE (Pharmacy Jurisprudence) Practice Exam

What percentage of controlled substances (CS) can a pharmacy distribute without being classified as a manufacturer?

1. 5%

2. 10%

3. 15%

4. 20%

The correct answer is: 5%

Controlled substances (CS) are drugs or substances regulated by the government due to their risk of misuse or abuse. In the United States, these substances are categorized into five schedules, with Schedule I being the most restricted and Schedule V being the least restricted. Pharmacies are establishments that dispense medication to patients, but they can also distribute controlled substances to other entities, such as hospitals or other pharmacies. In order to be classified as a distributor of controlled substances, a pharmacy must distribute more than 5% of its total annual dispensed prescriptions. Therefore, any pharmacy that distributes 5% or less of controlled substances is exempt from being classified as a manufacturer. If a pharmacy were to distribute more than 5%, it would be required to register as a manufacturer and follow additional regulations set by the Drug Enforcement Administration (DEA). Options B, C, and D are incorrect because they all exceed the 5% threshold. Any pharmacy that distributes more than 5% of controlled substances would be considered a manufacturer and would need to follow additional regulations. Option A is the correct answer because it is below the 5% threshold, indicating that a pharmacy can distribute up to 5% of controlled substances without being classified as a manufacturer.