What does it mean if a drug is considered to be "adulterated"?

A drug is considered to be "adulterated" when it does not meet quality standards set by regulatory bodies, such as the Food and Drug Administration (FDA). This may occur due to a variety of reasons, such as contamination with substances that could affect its safety or efficacy, improper manufacturing processes, or failing to adhere to specified guidelines regarding purity and strength. An adulterated drug may present significant health risks to patients, as it may not deliver the intended therapeutic effects or could potentially cause harm.

Adulteration focuses on the integrity and safety of the drug as it is produced and supplied to consumers. This definition is distinct from factors like expiration dates, reformulations, or the classification of a drug as over-the-counter, which pertain to other aspects of a drug's lifecycle and regulatory status. Understanding these definitions is crucial for ensuring that pharmaceuticals remain safe and effective for public use.