Durham-Humphrey Amendment
Encyclopedia
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. 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." 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.
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.
Prescription drug
A prescription medication is a licensed medicine that is regulated by legislation to require a medical prescription before it can be obtained. The term is used to distinguish it from over-the-counter drugs which can be obtained without a prescription...
) and over-the-counter
Over-the-counter drug
Over-the-counter drugs are medicines that may be sold directly to a consumer without a prescription from a healthcare professional, as compared to prescription drugs, which may be sold only to consumers possessing a valid prescription...
(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. 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." 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
Self-medication
Self-medication is a term used to describe the use of drugs or other self-soothing forms of behavior to treat untreated and often undiagnosed mental distress, stress and anxiety, including mental illnesses and/or psychological trauma...
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. 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.