South Carolina Multistate Pharmacy Jurisprudence Examination (MPJE) Practice Exam

What term describes drugs that were marketed before the FDCA of 1938?

1. Recently approved drugs

2. Grandfathered drugs

3. Conventional drugs

4. Restricted drugs

The correct answer is: Grandfathered drugs

The term that describes drugs that were marketed before the Federal Food, Drug, and Cosmetic Act (FDCA) of 1938 is "grandfathered drugs." These drugs were allowed to remain on the market without undergoing the new pre-market approval process established by the FDCA because they were already being sold and used prior to the law's enactment. As a result, they were "grandfathered" in, meaning they didn't need to meet the same requirements that newer drugs must fulfill to ensure safety and efficacy. The concept of grandfathering is essential in regulatory contexts, as it allows for continuity in the availability of certain drugs that have a long history of safe use, even if they were never formally evaluated under the newer standards. This is particularly relevant in pharmaceutical regulation, as it helps maintain patient access to established medications while still allowing for an enhanced review process for newer products.