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Legal Considerations in Off-Label Medication Prescribing
Arch Intern Med. 2002;162:1777-1779.
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| Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings. |
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There is considerable confusion in the medical profession about the
legal ramifications of prescribing off-label medications. Many of us have
been told by pharmaceutical companies that a drug is appropriate for this
or that indication. However, the label "indication" reflects only the manufacturer's
advertisement for that use for that product in that fashion and does not list
all of the medical indications for the use of that drug product.
In 1820, the United States Pharmacopoeia (USP) was formed to set standards
for the manufacture, nomenclature, indications, and chemical characteristics
of drugs. Federal law still has the USP setting those standards in 2002. In
1938, the Pure Food and Drug Act created the Food and Drug Administration
(FDA), the mission of which is to assure the safety, efficacy, and appropriate
labeling and advertising of pharmaceutical products before approving them
for sale. These products must meet the standards set by the USP.
. . . [Full Text of this Article]
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