Final answer:
When a drug with a REMS program is prescribed or dispensed without meeting the requirements, it is considered misbranded.
Step-by-step explanation:
When a drug has a REMS (Risk Evaluation and Mitigation Strategy) program and is prescribed or dispensed without meeting the requirements of the REMS, it is considered misbranded. Misbranding refers to the labeling or promotion of a drug that is false or misleading. In the case of a drug with a REMS program, it is important that the requirements of the program are followed to ensure patient safety and proper use of the drug.