West Virginia MPJE (Pharmacy Jurisprudence) Practice Exam

Which law required all Rx and OTC drugs to have a unique NDC number?

1. Controlled Substances Act

2. Drug Listing Act of 1972

3. Food, Drug, and Cosmetic Act of 1938

4. Kefauver-Harris Amendment of 1962

The correct answer is: Drug Listing Act of 1972

The Drug Listing Act of 1972 is indeed the correct answer because it established the requirement for all prescription (Rx) and over-the-counter (OTC) drugs to be assigned a unique National Drug Code (NDC) number. This system allows drugs to be specifically identified and tracked, facilitating better regulation and monitoring of drugs in the marketplace. The NDC is a standardized coding system that ensures consistency in reporting, tracking, and drug identification by manufacturers, pharmacies, and regulatory bodies. The implementation of this law significantly improved the ability to manage medications and their distribution. In contrast, the Controlled Substances Act primarily focuses on regulating the manufacture and distribution of controlled substances, while the Food, Drug, and Cosmetic Act of 1938 laid the foundation for the regulation of food and drugs but did not address the assignment of unique identifiers. The Kefauver-Harris Amendment of 1962 was significant for requiring drug efficacy and safety evidence before approval, but it likewise did not establish a system for unique drug identification. Thus, the Drug Listing Act of 1972 is the law that specifically mandated the unique NDC for all drugs.