What characterizes a misbranded drug?

A misbranded drug is characterized by having false or misleading labeling, which can include incorrect information about the drug’s ingredients, uses, warnings, or directions. The labeling must provide accurate and truthful information that helps consumers understand the product and use it safely. If the labeling is deceptive in nature, it can mislead patients and healthcare providers, potentially leading to unsafe use or ineffective treatment.

In contrast, other characteristics such as expiration or shelf life refer to the drug’s potency and safety over time but do not necessarily pertain to the labeling itself. A new formulation being introduced to the market does not affect whether a drug is classified as misbranded unless the labeling about this new formulation is inaccurate. Therefore, the essence of misbranding lies in the lack of truthful representation on the drug’s labeling.