West Virginia MPJE (Pharmacy Jurisprudence) Practice Exam

Which of the following accurately describes a requirement of the Drug Listing Act of 1972?

1. All drugs must display their NDC number

2. Manufacturers must prove drug efficacy

3. Clear distinction between OTC and Rx drugs

4. Drugs must meet USP and NF standards

The correct answer is: All drugs must display their NDC number

The Drug Listing Act of 1972 mandates that all prescription and over-the-counter drugs submitted for approval to the FDA must have a unique National Drug Code (NDC) number assigned. This system provides a standardized method for identifying drugs and facilitates tracking, as the NDC serves as a universal product identifier for medications distributed in the United States. The NDC number is crucial for ensuring that drugs can be accurately recorded and monitored throughout the supply chain, significantly enhancing reporting and safety measures in the pharmaceutical industry. The requirement for an NDC number emphasizes the importance of proper labeling and helps to prevent medication errors by distinctly associating each product with its manufacturer and formulation. Although aspects like proving drug efficacy, distinguishing between OTC and Rx drugs, and meeting USP and NF standards are important to drug regulation and safety practices, they are not specifically highlighted by the Drug Listing Act of 1972. This act is focused primarily on the identification and listing of drugs within the marketplace through the appropriate labeling of the NDC number.