Pharmacy Technician Certification Board Practice Exam

Which of the following products has been adulterated?

1. A bottle of valsartan that is not labeled with the phrase "Rx Only"

2. A vial of insulin that has been stored in a patient's car during a hot summer day

3. A bottle of OTC sleep aid tablets that does not have a child-resistant cap

4. A bottle of Crestor that does not contain the generic name of the label

The correct answer is: A vial of insulin that has been stored in a patient's car during a hot summer day

The concept of adulteration in pharmaceuticals refers to a product that has been subjected to contamination or has changed in composition, strength, or quality in a way that could potentially affect its safety or efficacy. In this situation, the vial of insulin that has been stored in a patient's car during a hot summer day is a clear example of adulteration. Insulin is a temperature-sensitive medication; it requires specific storage conditions to maintain its stability and effectiveness. Extreme heat can lead to the breakdown of the insulin, rendering it less effective or ineffective for the patient. Thus, the integrity of the medication has been compromised due to improper storage conditions. The other options, while related to labeling or packaging regulations, do not represent adulteration in the same way. For example, the absence of the "Rx Only" label or the generics names on the bottle affects compliance with labeling regulations but does not change the product's physical or chemical state. Similarly, the lack of a child-resistant cap for an OTC sleep aid tablet pertains to safety and regulatory compliance, not the actual integrity of the medication itself. Maintaining the correct storage conditions is critical for the effectiveness of medications like insulin, making the second option the appropriate choice for adulteration.