What characteristic may indicate that a drug is adulterated?

A drug is considered adulterated when it deviates from the accepted standards of strength, quality, or purity that are established by regulatory bodies. This definition aligns with the Federal Food, Drug, and Cosmetic Act, which specifies that a drug is adulterated if its strength differs from or its quality or purity falls below that which it claims to possess. For instance, if a medication contains less active ingredient than indicated, or if it contains impurities that compromise its intended effect and safety, it becomes adulterated. This characteristic directly impacts the efficacy and safety of the drug, making it a significant concern in pharmaceutical practice.

In contrast, issues such as incorrect labeling or lack of visible warnings may relate to misbranding rather than adulteration. Misbranding refers to misleading or false labels that could potentially lead to misunderstanding regarding the drug’s identity or effects but does not necessarily pertain to the actual content or integrity of the drug itself. Similarly, a drug that is not prescribed by a physician or lacks visible warnings does not inherently compromise its quality, strength, or purity, and therefore does not meet the criteria for adulteration.