What defines a drug as adulterated?

A drug is defined as adulterated when its quality or purity falls below established standards. This can occur when a substance is mixed with the drug to reduce its strength or effectiveness. Such dilution or reduction means that the drug does not conform to its recognized specifications or may even pose a safety risk to patients. Thus, if a drug is adulterated, it is not only ineffective but could also be dangerous, which is a critical aspect of ensuring safe and effective medication for patients.

In this context, while the mixing of a substance to enhance the strength of a drug and the presence of a tampered package are important considerations regarding the quality and integrity of a drug, they do not directly relate to the definition of adulteration according to regulatory standards. Additionally, the FDA's approval of a drug does not influence whether it is considered adulterated; rather, it signifies that the drug meets certain safety and efficacy criteria at the time of approval.