Washington Multistate Pharmacy Jurisprudence MPJE Practice Exam

If an OTC drug lacks any required labeling information, how is it categorized?

1. Defective

2. Recalled

3. Misbranded

4. Unsafe

The correct answer is: Misbranded

An OTC drug is categorized as misbranded if it lacks any required labeling information. This is because labeling information is necessary for consumers to make informed decisions about the safety and effectiveness of the drug. Option A is incorrect because the drug is not necessarily defective, it just lacks labeling information. Option B is incorrect because a recall would only happen if the drug has been deemed unsafe or defective by the FDA. Option D is incorrect because while the drug may be considered unsafe without proper labeling, that is not the specific category it falls under.