Durham-Humphrey Amendment

Durham-Humphrey Amendment

a 1952 modification of the 1938 U.S. Food, Drug, and Cosmetic Act. It differentiates between prescription and over-the-counter medications and specifies medications that can or cannot be refilled without a new prescription. It also identifies which original prescriptions and refills can be authorized over the telephone.
References in periodicals archive ?
Third, the Durham-Humphrey Amendment of 1951 to the Federal Food, Drug, and Cosmetic Act stipulates that a drug product cannot be marketed simultaneously both as a prescription and as a nonprescription product at the same strength and same dosage.
1950 Durham-Humphrey Amendment defines some drugs unsafe for self-medication and restricts their sale to by-prescription-only by a licensed practitioner.
dagger]) The distinction between prescription and over-the-counter drugs in the United States emerged with the 1938 federal Food, Drug and Cosmetic Act, and was institutionalized 13 years later, with the Durham-Humphrey Amendment.
As a result of the Durham-Humphrey Amendment of 1951 to the Federal Food, Drug, and Cosmetic Act which stipulates that a drug product cannot be marketed simultaneously both as a prescription and as a nonprescription product at the same strength and same dosage and for the same indication, the FDA issued warning letters on October 11, 2002, deeming all extended release guaifenesin tablets without an approved abbreviated new drug application (ANDA) or NDA illegal and misbranded.
The 1951 Durham-Humphrey Amendment defined the kinds of drugs that can't be safely used without medical supervision and restricted their sale to prescription by a licensed practitioner.