South Carolina Multistate Pharmacy Jurisprudence Examination (MPJE) Practice Exam

Which of the following is NOT a grandfathered drug?

1. Digoxin

2. Levothyroxine

3. Phenobarbital

4. Omeprazole

The correct answer is: Omeprazole

The identification of which drug is not grandfathered is based on the concept of grandfathering in the context of drug approval. A grandfathered drug is one that was already marketed before the establishment of the current drug approval process by the FDA and did not require premarket approval or extensive clinical trials. Digoxin, levothyroxine, and phenobarbital all fall under the category of drugs that were marketed before the enactment of the modern regulatory framework, thus they are considered grandfathered. These medications have long histories of use and were available when the FDA was not yet regulating all pharmaceuticals stringently. Omeprazole, on the other hand, is a proton pump inhibitor that was first approved in the 1980s and is classified as a new drug under the current regulations. Because it went through the modern drug approval process, it does not qualify as a grandfathered drug. Therefore, it is correctly identified as the option that is not grandfathered. Understanding the historical context of a drug's approval process is crucial when determining its regulatory status.