South Carolina Multistate Pharmacy Jurisprudence Examination (MPJE) Practice Exam

What happens to a product if its tamper evident packaging is broken?

1. It is considered misbranded

2. It is considered adulterated

3. It is automatically recalled

4. It is still safe to sell

The correct answer is: It is considered adulterated

When a product's tamper-evident packaging is broken, it is considered adulterated. This classification is based on the concerns for consumer safety and product integrity. Tamper-evident packaging is designed to provide a visual indication that a product may have been interfered with or compromised since the time of packaging. If this packaging is broken, it raises significant doubts about the sterility and safety of the product, as it could potentially expose the product to contamination or tampering after it has left the manufacturer. Consequently, the Food and Drug Administration (FDA) and various state regulations may classify such a product as adulterated, as the degradation of quality or safety can pose health risks to consumers. This characterization does not automatically imply that the product needs to be recalled; however, it indicates that the product is not fit for consumption without further evaluation. Thus, it cannot be sold in its current state. The other options reflect different concerns but do not capture the primary issue of safety and risk associated with the integrity of the packaging.