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Durham–Humphrey Amendment: Difference between revisions

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Passed in 1951, this amendment defined 2 specific categories for medications. Legend ([[prescription drug|prescription]]) and [[over-the-counter drug|over-the-counter]] (OTC).
Passed in 1951, this amendment defined 2 specific categories for medications, legend ([[prescription drug|prescription]]) and [[over-the-counter drug|over-the-counter]] (OTC).


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.<ref name="drug_law_evo">[http://www.fda.gov/FDAC/special/newdrug/benlaw.html The Evolution of U.S. Drug Law] Accessed 1 Apr 2009.</ref>
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.<ref name="drug_law_evo">[http://www.fda.gov/FDAC/special/newdrug/benlaw.html The Evolution of U.S. Drug Law] Accessed 1 Apr 2009.</ref>

Revision as of 07:00, 1 April 2009

Passed in 1951, this amendment defined 2 specific categories for medications, legend (prescription) and over-the-counter (OTC).

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.[1]

Legend drugs can only be dispensed with direct medical supervision whereas OTC drugs can be purchased and used without a prescription.

  1. ^ The Evolution of U.S. Drug Law Accessed 1 Apr 2009.