What classification applies to drugs containing unsafe color additives?

Drugs that contain unsafe color additives fall under the classification of adulterated. This is because the presence of such color additives makes the drug not conforming to the required quality and safety standards as specified by regulatory bodies, such as the Food and Drug Administration (FDA). Adulteration occurs when a substance is deemed impure or harmful, which compromises its safety for consumer use.

Color additives are specifically regulated due to potential health risks, and if a drug contains additives that have not been approved for safety, the drug can be considered adulterated. This means it fails to maintain the rightful purity or quality expectations necessary for medications intended for public consumption.

The other classifications do not accurately describe the situation with unsafe color additives. For example, while misbranding involves issues like false labeling or misleading information about the drug's effects or usage, the primary concern with unsafe color additives clearly relates to their safety and purity, categorically defining them as adulterated instead.