What characterizes an adulterated drug?

A drug is characterized as adulterated primarily when it is contaminated or decomposed. Adulteration signifies that a substance has been altered from its pure form or has been compromised in a manner that impacts its safety, efficacy, or quality. This could include instances where the drug has been mixed with non-sterile materials, contains harmful substances, or has deteriorated chemically or physically.

The other characteristics listed provide important considerations for drug safety and efficacy, but they do not directly define adulteration. For instance, marketing a drug under a false name pertains more to misbranding or fraud rather than to the drug's physical state. Similarly, a lack of proper labeling often falls under misbranding as well, focusing on how the product is presented to consumers rather than on its inherent purity or quality. Effectiveness beyond the expiration date touches on an aspect of efficacy but does not meet the specific criteria for adulteration, emphasizing instead the importance of using products before their labeled expiration for optimal safety.