Ohio Pharmacy Law Practice Test 2025 – 400 Free Practice Questions to Pass the Exam

A multiple-dose vial that exceeds its beyond use date is classified as adulterated. This classification comes from the definition in the Drug Enforcement Administration (DEA) and Food and Drug Administration (FDA) regulations that focus on the safety, quality, and labeling of medications.

An item is considered adulterated if it is harmful to patients or if it fails to meet quality standards because it has been stored or handled improperly. When a multiple-dose vial surpasses its beyond use date, it no longer guarantees the safety and efficacy that are expected from sterile products, which is a primary concern in pharmacy practice. This could be due to degradation of the active ingredients, changes in the chemical composition, or possible contamination, all of which can pose serious risks to patients.

Other classifications, such as contaminated, expired, or misbranded, while relevant in their contexts, do not accurately capture the implications of a medication exceeding its beyond use date as effectively as "adulterated." For instance, expired might suggest that the medication is simply no longer within its designated time frame for use, lacking the connotation of potential harm. Misbranded relates specifically to issues with labeling rather than the actual condition of the medication itself. Thus, identifying a vial exceeding its beyond use date as adulter