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What does it mean, off-label? What does it mean if a drug or a filler like Botox or Juvederm is used off-label?

Well, what is on-label? On-label means that it is being used for the reason or purpose that the drug company submitted to the Federal Drug Administration, the FDA, for that specific indication. So the FDA submits Botox, for example and says, "We want that drug to be approved by you for use in relaxing the muscle lines here in the forehead." The FDA does an extensive evaluation and it determines that, "Yes, it's fine. We approve this in this region."

Once the FDA approves it for one indication, and that's what it's called when you submit an application, you submit it with an indication... Once the FDA approves that indication, physicians are now free at their discretion and their judgment to use that medication or drug or injectable in other areas or for other reasons in the body if they deem it to be appropriate or necessary.

When you use it, when you use that drug on the same indication that the pharmaceutical company submitted to the FDA, it's called using it on-label. When you're using it in areas or for other reasons or other indications that was not formally submitted by the pharmaceutical company to the FDA, it's called using it off-label. So there's nothing wrong with using medications off-label. It's just not that which was very strictly and narrowly submitted by the pharmaceutical company to the FDA. I hope that answers your questions.

"Off-Label" Drug Use By a Physician: Is It Safe?

What does “off-label” mean? Is it safe to use a drug for something other than its intended purpose? Dr. Philip Miller explains what a physician is allowed to do with an FDA-approved product.

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