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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
Great Seal of the United States
Long title1951 Food, Drug, and Cosmetics Act Amendments
Enacted bythe 82nd United States Congress
Public law82-215
Statutes at Large65 Stat. 648
Acts amendedFederal Food, Drug, and Cosmetic Act
Acts repealedPure Food and Drug Act
Titles amended21 U.S.C.: Food and Drugs
U.S.C. sections amended21 U.S.C. ch. 9 § 301 et seq.
Legislative history

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.


  1. ^ a b This Week In FDA History... Accessed 1 Apr 2009.
  2. ^ The Evolution of U.S. Drug Law Accessed 1 Apr 2009.

See alsoEdit