Durham–Humphrey Amendment

The Durham–Humphrey Amendment explicitly defined two specific categories for medications, legend (prescription) and over-the-counter (OTC). This amendment was co-sponsored by then Senator (and later Vice President) Hubert H. Humphrey Jr., who was a pharmacist in South Dakota before beginning his political career.^[1] The other sponsor of this amendment was Carl Durham, a pharmacist representing North Carolina in the House of Representatives.

Durham–Humphrey Amendment

Long title	1951 Food, Drug, and Cosmetics Act Amendments
Enacted by	the 82nd United States Congress
Citations
Public law	82-215
Statutes at Large	65 Stat. 648
Codification
Acts amended	Federal Food, Drug, and Cosmetic Act
Acts repealed	Pure Food and Drug Act
Titles amended	21 U.S.C.: Food and Drugs
U.S.C. sections amended	21 U.S.C. ch. 9 § 301 et seq.
Legislative history
Signed into law by President Harry S. Truman on October 26, 1951

The bill requires any drug that is habit-forming or potentially harmful to be dispensed under the supervision of a health practitioner as a prescription drug and must carry the statement, "Caution: Federal law prohibits dispensing without a prescription."^[1]

Until this law, there was no requirement that any drug be labeled for sale by prescription only. The amendment defined prescription drugs as those unsafe for self-medication and which should therefore be used only under a doctor's supervision.^[2]

Legend drugs must be dispensed with direct medical supervision, but over-the-counter drugs can be purchased and used without a prescription.

The law also legalized verbal transmission of prescriptions and provided for the legal right of a pharmacist to refill prescriptions as indicated in a provider's initial prescription.

See also

• Federal Food, Drug, and Cosmetic Act
• Kefauver Harris Amendment
• Food and Drug Administration