West Virginia MPJE (Pharmacy Jurisprudence) Practice Exam

Which law mandated accurate product labeling and required ingredients to meet standards of strength, quality, and purity in the USP and NF?

1. Drug Listing Act of 1972

2. Durham-Humphrey Amendment of 1951

3. Kefauver-Harris Amendment of 1962

4. Pure Food and Drug Act of 1906 (Wiley Act)

The correct answer is: Pure Food and Drug Act of 1906 (Wiley Act)

The correct answer is the Pure Food and Drug Act of 1906, also known as the Wiley Act. This landmark legislation was one of the first to address issues related to food and drug safety in the United States. It mandated accurate labeling of products and required that any drugs sold had to meet standards of strength, quality, and purity as outlined in the United States Pharmacopeia (USP) and the National Formulary (NF). By setting these standards, the Act aimed to prevent the sale of misbranded and adulterated drugs, significantly impacting public health and consumer protection. The importance of accurate labeling and adherence to quality standards laid the groundwork for future regulations in the pharmaceutical industry. The other choices do not address the same requirements as the 1906 Act. For instance, the Drug Listing Act of 1972 focused on the registration of drug products with the FDA. The Durham-Humphrey Amendment of 1951 primarily addressed the distinction between prescription and over-the-counter drugs, while the Kefauver-Harris Amendment of 1962 emphasized the efficacy and safety of drugs, along with good manufacturing practices, but did not specifically mandate accurate labeling in the way the Pure Food and Drug Act did.