Rhode Island Multistate Pharmacy Jurisprudence (MPJE) Practice Exam

Medication that contains an unsafe coloring additive solely for color purposes is classified as what?

1. Impaired

2. Contaminated

3. Adulterated

4. Misbranded

The correct answer is: Adulterated

The classification of a medication that contains an unsafe coloring additive solely for color purposes as adulterated is grounded in the definitions provided under the Federal Food, Drug, and Cosmetic Act. A drug is considered adulterated if it contains any added substance that may render it harmful or unsafe to users. Unsafe coloring additives pose a significant risk to patients, as they could lead to allergic reactions or other health issues. In this context, the presence of an unsafe coloring agent does not merely affect the drug’s aesthetic appeal; it compromises the safety and efficacy of the product itself, which is the primary concern in pharmaceutical regulations. By classifying such a medication as adulterated, the law ensures that medications are safe and suitable for consumption, protecting public health. The other classifications do not apply in this scenario. Impaired refers to a state of reduced functioning, which does not pertain to the safety or composition of the medication. Contaminated typically indicates the presence of harmful or unwanted substances, but in this case, the focus is specifically on the unsafe coloring additive. Misbranded relates to labeling issues, such as misleading information, rather than the safety of the ingredients. Thus, adulterated is the most appropriate classification for medications containing unsafe coloring additives used solely for coloring purposes.