Arizona MPJE (Pharmacy Jurisprudence) Practice Exam

What categorization applies to a drug that contains an unsafe color additive?

1. Adulterated

2. Misbranded

3. Outdated

4. Recalled

The correct answer is: Adulterated

A drug that contains an unsafe color additive falls under the category of adulterated. The term "adulterated" refers to products that are contaminated or that do not meet the established quality standards set by regulatory bodies like the FDA. In the context of color additives, if these additives are deemed unsafe through testing, their presence in a drug renders it adulterated because they compromise the safety, purity, or effectiveness of the product. In contrast, misbranding typically involves misleading labels or false claims about the product itself rather than issues of safety or quality. Outdated refers to products that have surpassed their expiration dates, rendering them less effective or potentially harmful, but it doesn’t specifically address the issue of color additives. Recalled pertains to actions taken by a manufacturer or regulatory body to withdraw a product from the market due to safety concerns or defects; however, it does not inherently provide the same legal context as adulteration linked to the unsafe ingredient. Therefore, the presence of an unsafe color additive directly indicates that the drug has been adulterated.