Rhode Island Multistate Pharmacy Jurisprudence (MPJE) Practice Exam

What must be true for a drug to be classified as adulterated?

1. It must be outdated.

2. It must contain unapproved ingredients.

3. It must be mixed or packed in a way that reduces quality or strength.

4. It must have been dispensed without a prescription.

The correct answer is: It must be mixed or packed in a way that reduces quality or strength.

For a drug to be classified as adulterated, it must be mixed or packed in a way that reduces its quality or strength. This is a key aspect of pharmaceutical regulation, which aims to ensure that drugs are safe, effective, and meet the specified standards for purity and potency. Adulteration can occur through various means, such as improper manufacturing processes, contamination, or substandard practices during packaging or handling. This classification is crucial because it impacts the drug's safety profile and therapeutic efficacy. Therefore, if the quality or strength of the drug is compromised—whether intentionally or unintentionally—it is considered adulterated, thus violating the established standards of pharmacy practice. The other choices reflect aspects of drug quality control but do not directly define adulteration in the context of pharmacy law. Outdated drugs pertain more to the expiration and efficacy of a drug rather than the adulteration standard. The presence of unapproved ingredients relates to the concept of misbranding rather than adulteration. Finally, dispensing a drug without a prescription does not inherently affect its quality or strength, but it addresses legal compliance around dispensing practices.