The Durham-Humphrey Amendment of 1951
The Food, Drug, and Cosmetic Act was amended in 1951 by the Durham-Humphrey Amendment, which clarified the legal distinction between over-the-counter (OTC) and prescription drugs. 1
Historical Context
The original Food, Drug, and Cosmetic Act was passed in 1938 in response to the Elixir Sulfanilamide disaster, which required proof of safety before release of new drugs but did not address the OTC versus prescription distinction 2, 3. This 1938 law transformed the FDA from a policing agency focused on confiscating adulterated drugs into a regulatory agency overseeing new drug evaluation 2.
The 1951 Durham-Humphrey Amendment
This amendment established the legal framework that distinguishes prescription drugs (requiring physician supervision) from OTC medications (safe for self-administration without medical oversight) 1
The amendment addressed drug safety by creating clear criteria for which medications required professional medical supervision versus those that could be safely used by consumers without a prescription 1
Subsequent Drug Safety Legislation
The 1962 Kefauver-Harris Amendments to the Food, Drug, and Cosmetic Act further strengthened drug safety requirements by mandating that drug sponsors demonstrate evidence of effectiveness in addition to safety 1. This shifted the FDA's focus from relying on testimonials and clinical impressions to requiring substantial evidence from adequate and well-controlled trials 1.
Answer: 1951