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| 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| Acts repealed | Pure Food and Drug Act |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 | |
| |
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. 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 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
References
- ^ This Week In FDA History... Accessed 1 Apr 2009.
- The Evolution of U.S. Drug Law Accessed 1 Apr 2009.