Off label use of medications
In the United States , the Food and Drug Administration (FDA) requires
drug companies to conduct clinical trials to prove safety and efficacy
so the drug can be approved and taken to market as an approved drug.
The drugs manufacturer and FDA agree on specific drug package insert.
(Can be found inside the box containing the medications) The dose of
the medication, the route and the indications for usage are included on the drugs label. There is more information in the drugs package insert.
Once the FDA approves a drug for prescription use, they do not attempt
to regulate the practice of medicine. The physicians are allowed to
make decision based on their best judgment how to use the medication.
There is no requirement to adhere only to the published indication for
the specific drug. It is legal in the United States and countries over
the world to use drugs off-label, namely use the medications for other
medical indication that are not listed in the documents of the FDA , when the drug is approved. Some drugs are used more frequently off-label than for their original, FDA-approved indication.
--- On Tue, 7/1/08, jrrjim wrote:
I thought it was completely legal for any doctor to prescribe any
legal drug for any reason, including "off label" applications.
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