| Durham–Humphrey Amendment | |
| Fullname: | 1951 Food, Drug, and Cosmetics Act Amendments |
| Enacted By: | 82nd |
| Public Law Url: | http://www.gpo.gov/fdsys/pkg/STATUTE-65/pdf/STATUTE-65-Pg648.pdf |
| Cite Public Law: | 82-215 |
| Cite Statutes At Large: | 65 Stat. 648 |
| Acts Amended: | Federal Food, Drug, and Cosmetic Act |
| Acts Repealed: | Pure Food and Drug Act |
| Title Amended: | 21 U.S.C.: Food and Drugs |
| Sections Amended: | § 301 et seq. |
| Introducedbill: | H.R. 3298 |
| Signedpresident: | Harry S. Truman |
| Signeddate: | October 26, 1951 |
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.
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.