Arizona MPJE (Pharmacy Jurisprudence) Practice Exam

Drugs that violate the Current Good Manufacturing Practice (CGMP) standards are deemed:

1. Expired

2. Misbranded

3. Counterfeit

4. Adulterated

The correct answer is: Expired

Drugs that violate the Current Good Manufacturing Practice (CGMP) standards are deemed adulterated. CGMP regulations are enforced by the FDA to ensure that drug products are produced consistently and are of high quality. When these standards are not met, it compromises the safety, identity, strength, quality, or purity of the drug, leading to its classification as adulterated under the Food, Drug, and Cosmetic Act. Adulteration can occur due to various reasons, such as contamination, improper processing, or failing to meet quality control standards. This classification aims to protect public health by preventing substandard drugs from reaching consumers. The other classifications, such as expired, misbranded, or counterfeit, relate to different issues. Expired refers to products beyond their shelf life; misbranded indicates labeling issues leading to potential consumer deception; counterfeit drugs involve deception in terms of their origin or composition, often involving imitation for illegal profit. Each of these classifications addresses different aspects of drug quality and regulation, but violations of CGMP specifically lead to a drug being considered adulterated.