| Full title | 1951 Food, Drug, and Cosmetics Act Amendments |
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| Enacted by the | 82nd United States Congress |
| Citations | |
| Public Law | 82-215 |
| Stat. | 65 Stat. 648 |
| Codification | |
| Act(s) amended | Federal Food, Drug, and Cosmetic Act |
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| Major amendments | |
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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 former vice president and senator 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.
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] Bill also requires that all drugs have adequate directions for use.
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 can only be dispensed with direct medical supervision whereas OTC drugs can be purchased and used without a prescription. This 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.