Arizona MPJE (Pharmacy Jurisprudence) Practice Exam

What term describes a drug that is not manufactured in accordance with Good Manufacturing Practice (GMP) regulations?

1. Adulterated

2. Misbranded

3. Outdated

4. Recalled

The correct answer is: Adulterated

The correct term for a drug that is not manufactured in accordance with Good Manufacturing Practice (GMP) regulations is "adulterated." Adulteration refers to the contamination or degradation of a drug’s purity, strength, or quality due to improper manufacturing processes. According to the Federal Food, Drug, and Cosmetic Act, an article is considered adulterated if it has been produced in a way that does not meet the stringent standards set forth by GMP, thereby compromising its safety and effectiveness for consumer use. Understanding this concept is essential in pharmacy practice, as it directly impacts patient health and safety. An adulterated drug may pose significant risks due to improper formulation, contamination, or failing to meet the necessary quality standards. The other terms do have specific meanings in the context of pharmaceuticals. Misbranding refers to labeling issues that can mislead or deceive a consumer about the drug's identity, ingredients, or use. Outdated drugs refer to those that have passed their expiration date and may no longer be effective or safe. Recalled drugs are those that have been identified to be unsafe or defective and have been pulled from the market by the manufacturer or regulatory authorities. However, these terms do not specifically address the issue of manufacturing practices as adulteration does.