South Carolina Multistate Pharmacy Jurisprudence Examination (MPJE) Practice Exam

For which types of products are MedGuides required by the FDA?

1. High-cost medications

2. Products posing a serious concern

3. Only new medications

4. All over-the-counter drugs

The correct answer is: Products posing a serious concern

MedGuides are required by the FDA for products posing a serious concern regarding safety or effectiveness in order to provide patients with critical information. The purpose of MedGuides is to inform patients about specific risks associated with certain medications, including potential adverse effects, proper usage, and precautions that need to be taken. This requirement applies not only to new medications but also to established drug products deemed to have significant safety issues, ensuring that patients are adequately informed. In contrast, while high-cost medications and over-the-counter drugs might have their own unique considerations, they are not the primary determining factors for requiring MedGuides. Specifically, MedGuides are not limited to only new medications, since existing therapies can also be subject to these requirements if their use carries substantial risk.