South Carolina Multistate Pharmacy Jurisprudence Examination (MPJE) Practice Exam

Which of the following represents a criterion for a drug to be considered adulterated?

1. Contains false labeling

2. Prepared under sanitary conditions

3. Contains unapproved color additives

4. Meets GMP standards

The correct answer is: Contains unapproved color additives

A drug is considered adulterated when it violates certain safety or quality standards set forth by law. One key criterion for a drug to be classified as adulterated is if it contains unapproved color additives. These color additives can pose risks to consumers, including allergic reactions or other health hazards if they have not been tested for safety and effectiveness. Federal regulations require that all color additives used in food and drugs must be approved by the FDA, and the presence of unapproved additives can compromise the integrity of the product, thus leading to classification as adulterated. In contrast, a drug that is prepared under sanitary conditions does not raise concerns of adulteration. Additionally, a drug that meets current Good Manufacturing Practice (GMP) standards signifies that it has been produced in a controlled environment that adheres to safety and quality regulations; therefore, it would not be considered adulterated. Lastly, false labeling relates to misbranding rather than adulteration, as it concerns the accuracy of the information provided to consumers rather than the drug's composition or safety. Thus, the presence of unapproved color additives is a clear violation that directly aligns with the definition of adulteration.