The Elixir sulfanilamide disaster led to the passage of which act?

The Elixir sulfanilamide disaster led to the passage of which act?

• A. Pure Food and Drug Act of 1906
• B. Food, Drug, and Cosmetic Act of 1938
• C. Durham-Humphrey Amendment of 1951
• D. Drug Abuse Control Amendment Act of 1965

Answer: (B)

Ensuring drug safety before products reach consumers is the focus here. The Elixir sulfanilamide disaster in 1937, where a toxic solvent was used to make a sulfa药, showed that drugs could be marketed without proof of safety. In response, Congress passed the Food, Drug, and Cosmetic Act of 1938, which gave the FDA authority to require safety testing for new drugs and to enforce proper labeling and manufacturing standards. This marked a major shift from the earlier act, addressing the urgent need to prevent tragedies like that one. Later changes would add requirements for efficacy, but the disaster directly spurred the 1938 act. The other options relate to later regulatory changes (prescription vs. OTC, and drug control provisions) rather than the immediate reaction to the 1937 crisis.

Ensuring drug safety before products reach consumers is the focus here. The Elixir sulfanilamide disaster in 1937, where a toxic solvent was used to make a sulfa药, showed that drugs could be marketed without proof of safety. In response, Congress passed the Food, Drug, and Cosmetic Act of 1938, which gave the FDA authority to require safety testing for new drugs and to enforce proper labeling and manufacturing standards. This marked a major shift from the earlier act, addressing the urgent need to prevent tragedies like that one. Later changes would add requirements for efficacy, but the disaster directly spurred the 1938 act. The other options relate to later regulatory changes (prescription vs. OTC, and drug control provisions) rather than the immediate reaction to the 1937 crisis.