Pharmacy Technician PTCB Practice Test

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Which federal law introduced a 'proof-of-efficacy' requirement?

  1. Pure Food and Drug Act

  2. Harrison Narcotic Act

  3. Kefauver Harris Amendment

  4. Drug Efficacy Amendment

The correct answer is: Kefauver Harris Amendment

The Pure Food and Drug Act and the Harrison Narcotic Act both addressed issues related to drug safety, but did not introduce the 'proof-of-efficacy' requirement. The Drug Efficacy Amendment, also known as the Durham-Humphrey Amendment, addressed prescription drug labeling but did not introduce the 'proof-of-efficacy' requirement. The Kefauver Harris Amendment, passed in 1962, introduced the 'proof-of-efficacy' requirement which required drug manufacturers to provide proof that their products were effective for their intended use before they could be marketed. This was a significant step in ensuring the safety and efficacy of drugs for consumers.

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