South Carolina Multistate Pharmacy Jurisprudence Examination (MPJE) Practice Exam

What differentiates a drug as adulterated?

1. It is poorly marketed

2. It is unsafe and/or of inferior quality

3. It lacks a proper prescription

4. It is not FDA approved

The correct answer is: It is unsafe and/or of inferior quality

A drug is considered adulterated primarily if it is unsafe and/or of inferior quality. This definition revolves around the integrity of the drug's composition or its manufacturing processes. Adulteration can occur for a variety of reasons, such as contamination, the use of inferior ingredients, or deviations from established manufacturing standards. This can ultimately compromise the drug's efficacy and safety for patients. In contrast, the other options do not directly address the standards that determine whether a drug is adulterated. For instance, while inadequate marketing might affect a drug's sales, it does not impact the quality or safety of the product itself. Lacking a proper prescription pertains more to regulatory compliance and the legal authority to dispense the drug rather than its physical properties. Furthermore, being unapproved by the FDA implies a lack of authorization for use but does not inherently mean the drug is adulterated; it may simply not meet regulatory requirements for approval without any indication of being unsafe or inferior in quality. Thus, the key factor that makes a drug adulterated is its unsafe nature or inferior quality.