PTCB Certified Pharmacy Technician (PTCE)Federal RequirementsEasy
A patient calls the pharmacy asking about the difference between over-the-counter (OTC) medications and prescription (Rx) medications. Which federal act primarily established the distinction between these two categories of drugs?
- AControlled Substances Act (CSA) of 1970
- BDurham-Humphrey Amendment of 1951
- CFederal Food, Drug, and Cosmetic Act (FDCA) of 1938
- DKefauver-Harris Amendment of 1962
Show answer & explanationAnswer & explanation
Correct answer: B. Durham-Humphrey Amendment of 1951
The Durham-Humphrey Amendment of 1951 specifically established the criteria for distinguishing prescription drugs from over-the-counter (OTC) drugs, making it illegal to dispense prescription drugs without a prescription.
Why the other options are wrong
- A. The CSA regulates controlled substances, not the general Rx vs. OTC distinction.
- C. The FDCA established FDA authority but didn't clearly define Rx vs. OTC.
- D. The Kefauver-Harris Amendment focused on drug efficacy and safety, not Rx vs. OTC classification.
Durham-Humphrey Amendment (1951)
The Durham-Humphrey Amendment of 1951 is a federal law that established the distinction between prescription (legend) drugs and over-the-counter (OTC) drugs, requiring a prescription for drugs that are habit-forming, unsafe for self-medication, or new drugs not yet proven safe for OTC use.
- Defined Rx vs. OTC categories.
- Required 'Rx only' label for prescription drugs.
- Made oral prescriptions and refills legal.
Memory trick: Durham-Humphrey: Differentiated Drugs, Humphrey's Rx is for Me!