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  • The Durham-Humphrey Amendment explicitly defined two specific categories for medications, legend and over-the-counter. This amendment was co-sponsored by then Senator Hubert H. Humphrey Jr., who was a pharmacist in South Dakota before beginning his political career. The other sponsor of this amendment was Carl Durham, a pharmacist representing North Carolina in the House of Representatives. 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." 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. Legend drugs can only be dispensed with direct medical supervision whereas OTC drugs can be purchased and used without a prescription.

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