South Carolina Multistate Pharmacy Jurisprudence Examination (MPJE) Practice Exam

What significant law was enacted in response to the deaths caused by diethylene glycol in sulfanilamide elixir?

1. Controlled Substances Act

2. Food, Drug, and Cosmetic Act

3. Kefauver-Harris Amendment

4. Orphan Drug Act

The correct answer is: Food, Drug, and Cosmetic Act

The significant law enacted in response to the deaths caused by diethylene glycol in sulfanilamide elixir is the Food, Drug, and Cosmetic Act. This law, passed in 1938, was a direct reaction to the tragic incident in which over 100 people died due to the consumption of this toxic substance that was present in the elixir. The act aimed to ensure the safety and efficacy of drugs before they could be marketed to the public. Prior to this law, the regulation of food and drug products was limited, and the sulfanilamide incident exposed severe gaps in consumer protection. The enactment of the Food, Drug, and Cosmetic Act established more stringent requirements for drug approval and mandated that drugs be tested for safety before they could be sold. It also set the groundwork for the modern framework of drug regulation, including labeling requirements and prohibitions against false advertising. The other options, while important in the history of drug regulation, are not directly related to the sulfanilamide tragedy. The Controlled Substances Act mainly regulates drugs with a potential for abuse; the Kefauver-Harris Amendment focused on drug efficacy and safety following thalidomide issues, and the Orphan Drug Act was established to encourage the development of treatments