Prescription Drug Amendment

The Durham-Humphrey amendment, known as the prescription drug amendment, sets standards to distinguish prescription drugs that require supervision by a licensed health practitioner from less risky and harmful over-the-counter (OTC) drugs. 

Hubert Humphrey, Democratic senator from Minnesota from 1949 to 1964, and again from 1971 to 1978, and vice president of the United States from 1965 to 1969. A pharmacist before going into politics, Humphrey cosponsored the 1951 Prescription Drug Amendment that defined the distinction between prescription drugs that required supervision by a physician and OTC drugs. The law remains a key to the system of prescription drugs today. 

The Prescription Drug Marketing Act of 1988 amended the FD C Act to estabUsh newer safeguards for the national distribution of prescription dmg products. It limits the reimportation of dmg products manufactured in the United States to the product manufacturers only. It also prohibits the selling, trading, and purchasing of sample dmg products and places restrictions upon their distribution. 

Safe Medical Device Amendments, requiring more extensive testing of devices. 1992 Prescription Drug User Fee Act. Established the payment of fees for the filing of applications (e.g., IND, NDA, PLA, etc.)... 

Durham-Humphrey Amendment (1951). 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 be used only under a doctor s supervision. 

This legislation amended the Federal Food, Drug, and Cosmetic Act to improve the regulation of prescription drugs (as well as medical devices and food). The law notes that the PDUFA of 1992 successfully reduced review times and reauthorized the user fees to expedite the review process. Other provisions aimed to give some patients access to experimental drugs. Beyond that, the law made several other changes. 

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