Question

question 92

a pharmacy technician should recognize that which of the following laws requires medication manufacturers to place a label stating, \caution: federal law prohibits dispensing without a prescription\ on medication stock bottles?

poison prevention packaging act (pppa)
orphan drug act
durham-humphrey amendment
kefauver-harris amendment

Explanation:

Analyze the question prompt

Using the Pharmacy Law knowledge point, we identify the legal requirement for the federal legend "Caution: Federal law prohibits dispensing without a prescription" (or "Rx only") on manufacturer stock bottles.

Evaluate the Durham-Humphrey Amendment

The Durham-Humphrey Amendment of 1951 established two distinct classes of drugs: prescription (legend) and over-the-counter (OTC). It mandated that prescription drugs must carry this specific warning label.

Rule out incorrect options

Using the Poison Prevention Packaging Act knowledge point, we know the PPPA of 1970 regulates child-resistant packaging. The Orphan Drug Act of 1983 provides incentives for rare disease treatments. The Kefauver-Harris Amendment of 1962 focused on drug safety and efficacy.

Answer:

• Poison Prevention Packaging Act (PPPA)
• Orphan Drug Act
• Durham-Humphrey Amendment (Correct answer)
• Kefauver-Harris Amendment