South Carolina Multistate Pharmacy Jurisprudence Examination (MPJE) Practice Exam

Which condition would NOT classify a drug as adulterated?

1. Contains decomposed substances

2. Prepared under GMP

3. Hold under unsanitary conditions

4. Contains an unapproved color additive

The correct answer is: Prepared under GMP

A drug is classified as adulterated if it does not meet certain quality and safety standards as outlined by regulatory bodies. The correct answer indicates that a drug prepared under Good Manufacturing Practices (GMP) does not fall into the category of adulteration. Good Manufacturing Practices are established regulations that ensure pharmaceuticals are produced consistently and controlled according to quality standards. When a drug is prepared in accordance with GMP, it demonstrates adherence to necessary safety and quality procedures, minimizing the risk of contamination, deviation, or any forms of adulteration. In contrast, the other conditions listed are indicative of adulteration. For example, if a drug contains decomposed substances or is held under unsanitary conditions, these scenarios directly compromise the drug's integrity, safety, and efficacy, leading to its classification as adulterated. Additionally, the presence of unapproved color additives suggests that the drug may have unauthorized or unsafe components, further solidifying the classification of adulteration. Thus, being prepared under GMP serves as a safeguard against adulteration, highlighting why this choice does not classify a drug as adulterated.