South Carolina Multistate Pharmacy Jurisprudence Examination (MPJE) Practice Exam

Which of the following drugs is an example of a grandfathered drug?

1. Ibuprofen

2. Levothyroxine

3. Paracetamol

4. Amoxicillin

The correct answer is: Levothyroxine

The correct answer is Levothyroxine, which is considered a grandfathered drug in the context of its approval pathway. A grandfathered drug is one that was marketed before the implementation of stricter regulatory requirements, particularly the New Drug Application (NDA) process established by the Food, Drug, and Cosmetic Act in 1962. Levothyroxine was originally approved and marketed before these regulations were enacted, allowing it to continue being sold without undergoing the modern approval process that newer drugs must complete. Ibuprofen, paracetamol (also known as acetaminophen), and amoxicillin are not considered grandfathered drugs. They were either approved under the contemporary New Drug Application process or through other pathways that require a standard review for safety and efficacy under current regulations. Understanding the nature of grandfathered drugs is crucial when examining pharmaceutical history and regulatory frameworks, as it highlights how certain medications remain in use despite the evolution of drug approval standards.