Rhode Island Multistate Pharmacy Jurisprudence (MPJE) Practice Exam

What is required on the label for a drug containing certain controlled substances to avoid being misbranded?

1. A clear expiration date

2. A cautionary statement about federal law

3. An FDA approval number

4. A statement against how it can be used

The correct answer is: A cautionary statement about federal law

The requirement for a cautionary statement about federal law on the label of a drug containing certain controlled substances is essential in preventing the drug from being misbranded. This statement typically indicates that the drug is subject to certain regulatory controls and that misuse could lead to legal consequences, thereby providing crucial information to the dispenser and the patient about the nature of the drug they are handling. In the context of federal regulations, this warning helps to ensure that patients and healthcare providers are aware that the drug has a high potential for abuse and dependence, which is characteristic of many controlled substances. It emphasizes the importance of proper use and the legal ramifications of misuse, and thus is a critical aspect of pharmaceutical labeling. The inclusion of such a statement ensures compliance with the Controlled Substances Act and aligns with the risk management strategies intended to protect public health and safety, while also keeping the pharmacy and healthcare provider informed about their legal responsibilities. The absence of this statement could lead to legal complications and harm to patients, thereby meeting the definition of misbranding as established by regulations.