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Comments, Opinions, and Brief Case Reports
August 12/26, 2002

Legal Considerations in Off-Label Medication Prescribing

Arch Intern Med. 2002;162(15):1777-1779. doi:

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.

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