Rhode Island Multistate Pharmacy Jurisprudence (MPJE) Practice Exam

What happens to a drug if it is mixed with another substance that decreases its potency?

1. It is considered effective.

2. It is certified for commercial use.

3. It is classified as adulterated.

4. It remains unchanged.

The correct answer is: It is classified as adulterated.

When a drug is mixed with another substance that decreases its potency, it is classified as adulterated. Adulteration refers to the process of making a product impure by adding inferior substances or by changing its composition in a way that can diminish its quality, strength, or purity. In the context of pharmaceuticals, the integrity of a drug must be maintained to ensure its safety and efficacy. If the potency of a drug is compromised due to the introduction of an inferior substance, it no longer meets the standards set for that particular medication. This has serious implications for patient safety and therapeutic effectiveness. The classification of a drug as adulterated signifies that it does not conform to official compendial standards and may pose risks to patients. In contrast, if a drug were simply effective or unchanged, it would imply that its quality and effectiveness had not been compromised, which is not the case when a substance negatively impacts its potency. Similarly, being certified for commercial use requires compliance with specific regulatory standards, which would not be met in the presence of adulteration. Hence, the correct understanding emphasizes that the integrity of the drug is critical, and the introduction of a substance that lowers its potency necessitates the classification as adulterated.