South Carolina Multistate Pharmacy Jurisprudence Examination (MPJE) Practice Exam

What is the status of a drug if it is deemed misbranded?

1. It is legally sold

2. It is not allowed for sale

3. It can be relabeled

4. It may still be effective

The correct answer is: It is not allowed for sale

When a drug is deemed misbranded, it is considered to have not met the legal requirements for labeling as established by the Food, Drug, and Cosmetic Act. Misbranding can occur if the labeling is false or misleading, if it fails to bear adequate directions for use, or if it does not have the necessary warning statements, among other reasons. As a result of being misbranded, the drug does not comply with regulatory standards, which can lead to restrictions on its sale and distribution. A misbranded drug may be subject to seizure and can be prohibited from being sold until the labeling issues are resolved. Thus, the status of a misbranded drug is such that it is not legally allowed for sale until the misbranding is corrected. The implications of this classification ensure that consumers are protected from products that may not be adequately labeled or could pose safety risks due to improper information.