Arizona MPJE (Pharmacy Jurisprudence) Practice Exam

What was a primary consequence of the sulfanilamide tragedy that led to the Food, Drug, and Cosmetic Act of 1938?

1. Requirement to prove safety before marketing drugs

2. Severe restrictions on foreign drug imports

3. Mandatory drug price regulations

4. Pharmacy practice certifications

The correct answer is: Requirement to prove safety before marketing drugs

The primary consequence of the sulfanilamide tragedy was the establishment of a requirement that manufacturers prove the safety of their drugs before they could be marketed to the public. Prior to this event, there was little regulatory oversight over drugs, allowing potentially harmful substances to be sold without adequate safety testing. The sulfanilamide tragedy involved the use of a toxic solvent, which led to serious harm and fatalities among patients using the medication. In response to this public health crisis, the Food, Drug, and Cosmetic Act of 1938 was enacted, fundamentally changing the landscape of pharmaceutical regulation in the United States. The act mandated that drug manufacturers must provide evidence of safety for their drugs prior to approval by the Food and Drug Administration (FDA). This requirement was aimed at preventing further tragedies and ensuring that the medications reaching consumers were safe for use. The other choices do not capture the essence of the legislative change brought about by this tragedy. While restrictions on foreign drug imports and pharmacy practice certifications may hold relevance in different contexts, they do not specifically reflect the immediate regulatory response to the safety failures highlighted by the sulfanilamide incident. Additionally, mandatory drug price regulations were not a focus of the 1938 Act, which primarily dealt with safety and efficacy standards rather