PTCB Certified Pharmacy Technician (PTCE)Federal RequirementsHard
A pharmacy technician is reviewing an order for a new medication. The label indicates 'Rx Only'. This designation signifies that the drug is considered safe and effective only when used under the supervision of a licensed practitioner. Which federal act established this distinction between prescription and non-prescription drugs?
- ADurham-Humphrey Amendment of 1951
- BKefauver-Harris Amendment of 1962
- CPure Food and Drug Act of 1906
- DFood, Drug, and Cosmetic Act of 1938
Show answer & explanationAnswer & explanation
Correct answer: A. Durham-Humphrey Amendment of 1951
The Durham-Humphrey Amendment of 1951 explicitly defined prescription drugs as those requiring medical supervision for safe use and established the 'Rx Only' label.
Why the other options are wrong
- B. The Kefauver-Harris Amendment required drugs to be proven effective as well as safe, in response to the thalidomide tragedy.
- C. The Pure Food and Drug Act focused on preventing misbranding and adulteration, not Rx vs. OTC distinction.
- D. The Food, Drug, and Cosmetic Act required drugs to be proven safe before marketing, but didn't formally separate Rx from OTC.
Durham-Humphrey Amendment
A 1951 amendment to the Food, Drug, and Cosmetic Act that legally established the distinction between prescription (legend) drugs and over-the-counter (OTC) drugs.
- Defined drugs that require a prescription.
- Mandated the 'Rx Only' or 'Caution: Federal law prohibits dispensing without a prescription' label.
- Authorized verbal prescriptions and prescription refills.
Memory trick: Food & Drug Acts: Pure, Cosmetic, Durham-Humphrey, Kefauver.