If a drug is refrigerated at a temperature that is too high, how is that drug classified?

When a drug is refrigerated at a temperature that is too high, it can lead to changes in the drug's potency, efficacy, or stability. In the context of regulatory definitions, this scenario typically results in the drug being classified as adulterated.

Adulteration refers to any situation where a product's purity or quality is compromised. This can occur due to improper storage conditions, such as being kept at incorrect temperatures, which may allow for degradation or bacterial contamination. The law requires that drugs meet specific standards of strength, quality, or purity; thus, improper refrigeration would violate these standards and categorize the drug as adulterated.

In contrast, mislabeling and misbranding relate to how a product is presented and marketed, usually concerning the information provided on its packaging rather than its physical state or quality. Expiration refers specifically to the date until which a drug is expected to remain effective, but simply being stored improperly does not inherently indicate that a drug has expired. Therefore, the correct classification for a drug stored under inappropriate refrigeration is adulterated.