Arizona MPJE (Pharmacy Jurisprudence) Practice Exam

What significant requirement was introduced by the Food, Drug, and Cosmetic Act of 1938?

1. Authorization for generic drug approval

2. Requirement for drugs to be proven safe before marketing

3. Definition of prescription drugs

4. Limited advertising of drugs

The correct answer is: Authorization for generic drug approval

The correct answer is the requirement for drugs to be proven safe before marketing. The Food, Drug, and Cosmetic Act of 1938 was a pivotal piece of legislation that established foundational standards for drug safety in the United States. Prior to this act, there were no formal requirements for drug manufacturers to demonstrate the safety of their products. This meant that drugs could be marketed without any scientific backing on their safety, leading to potential risks for consumers. The act specifically mandated that any new drug must be proven safe when used as directed before it could be marketed to the public. This shifted the responsibility onto pharmaceutical companies to conduct adequate testing and submit evidence of safety to the Food and Drug Administration (FDA) prior to sale. This legislation aimed to protect public health and ensure that consumers had access to medications that had undergone rigorous evaluation for safety. In contrast, while the authorization for generic drug approval and the definition of prescription drugs are important regulatory concepts, they were introduced later or were not specifically established by the 1938 act. Limited advertising of drugs may be relevant to pharmaceutical marketing practices but wasn't a central focus of the 1938 legislation. This context highlights the significance of the safety requirement introduced by the Food, Drug, and Cosmetic Act, impacting drug regulation and consumer