Question:
The Durham-Humphrey Amendment of 1951 primarily introduced. How it impacts pharmacy practice in India:
The Durham-Humphrey Amendment of 1951 primarily introduced. How it impacts pharmacy practice in India:
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Durham-Humphrey created the "Legend" (Rx) label.
Updated On: May 25, 2026
- Classification of drugs into prescription (legend) and over-the-counter (OTC) categories
- Mandatory proof of drug efficacy before marketing approval
- Regulation of cosmetic products under federal law
- Requirement of informed consent in clinical trials
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The Correct Option is A
Solution and Explanation
Step 1: Concept
The Durham-Humphrey Amendment is a significant piece of US legislation that influenced global drug regulations.
Step 2: Meaning
Before this amendment, there was no clear legal distinction between drugs that required a physician's oversight and those that did not.
Step 3: Analysis
This law established two specific categories: "Legend drugs" (Prescription only) and OTC drugs. It also prohibited unauthorized refills. This concept of scheduling drugs (like Schedule H in India) stems from this foundational regulatory logic.
Step 4: Conclusion
The primary introduction was the classification of prescription vs. non-prescription drugs. Final Answer: (A)
The Durham-Humphrey Amendment is a significant piece of US legislation that influenced global drug regulations.
Step 2: Meaning
Before this amendment, there was no clear legal distinction between drugs that required a physician's oversight and those that did not.
Step 3: Analysis
This law established two specific categories: "Legend drugs" (Prescription only) and OTC drugs. It also prohibited unauthorized refills. This concept of scheduling drugs (like Schedule H in India) stems from this foundational regulatory logic.
Step 4: Conclusion
The primary introduction was the classification of prescription vs. non-prescription drugs. Final Answer: (A)
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