What does adulteration refer to in the context of pharmaceuticals?

Adulteration in the context of pharmaceuticals refers to the situation where a drug is listed in the United States Pharmacopeia (USP) but does not meet the purity or quality standards set forth by the USP. This can occur due to various reasons such as contamination, improper storage, or the addition of inferior ingredients. When a drug is deemed adulterated, it may pose a risk to patient safety and is considered unlawful for distribution or use.

Understanding the definition of adulteration is crucial for pharmacy practice and maintaining compliance with regulatory standards. This ensures that medications dispensed to patients are safe, effective, and manufactured to appropriate quality levels. In contrast, drugs that meet all USP standards, drugs stored at room temperature, and expired drugs do not specifically pertain to the concept of adulteration as defined by quality and purity violations.