South Carolina Multistate Pharmacy Jurisprudence Examination (MPJE) Practice Exam

Which law established standards for Good Manufacturing Practices (GMP)?

1. Drug Enforcement Administration Act

2. Orphan Drug Act

3. Kefauver-Harris Amendment

4. Food, Drug, and Cosmetic Act

The correct answer is: Kefauver-Harris Amendment

The Kefauver-Harris Amendment is the correct answer because it specifically established requirements for Good Manufacturing Practices (GMP) in the pharmaceutical industry. This amendment, enacted in 1962, was a significant piece of legislation that aimed to ensure the safety and efficacy of drugs. It not only mandated that drugs must be proven effective before approval but also introduced standards for their manufacture and packaging, which includes the adherence to GMP. The importance of GMP lies in creating a framework for consistency, ensuring that drugs are produced in a controlled environment and meet quality standards that protect patient safety. By regulating the manufacturing processes, the Kefauver-Harris Amendment helped to prevent the distribution of contaminated or substandard medications. The other choices do not address GMP standards in the same comprehensive way. The Drug Enforcement Administration Act focuses on the control of narcotics and dangerous drugs. The Orphan Drug Act specifically encourages the development of drugs for rare diseases but does not cover GMP. The Food, Drug, and Cosmetic Act provided the foundational legislation for regulating food and drugs but did not specifically establish the GMP standards that were later detailed in the Kefauver-Harris Amendment.