What is off-label use? It's when a prescriber uses a drug the FDA has already approved in a way its official label doesn't describe: for a different condition, at a different dose, in a different age group, or by a different route. It's legal, it's common, and it's a judgment made for one patient at a time.

It also isn't the same as a compounded medication, or as a substance that has never had an approved product. People mix those three up constantly, and the difference changes what you're actually being prescribed.

What is off-label use, officially?

The "label" is the drug's prescribing information: the document the FDA signs off on at approval, saying what the drug is for, at what doses, for whom, and with what risks. Off-label means stepping outside it.

FDA's patient page, Understanding Unapproved Use of Approved Drugs "Off Label" (content current as of February 5, 2018), says it plainly: "Unapproved use of an approved drug is often called 'off-label' use." Its examples are a cancer drug approved for one cancer used for another, a capsule given as an oral solution, and two tablets a day when the label says one. FDA's drug repurposing page counts a new population, such as an age group the label doesn't cover, as a new use too.

The line that matters most: for an off-label use, "FDA has not determined that the drug is safe and effective for the unapproved use." The drug has been reviewed. That particular use hasn't.

Off-label drug use examples with GLP-1s

GLP-1 medicines, which mimic a gut hormone involved in appetite and blood sugar, make this concrete. Ozempic's label (DailyMed, Revised: 5/2026) lists three uses, all in adults with type 2 diabetes: blood-sugar control and two kinds of heart and kidney protection. Weight management alone isn't one of them; Wegovy, the same molecule, carries that use. So Ozempic prescribed only for weight loss is off-label by condition. The brand-by-brand list is in what semaglutide is used for.

Age works the same way. Wegovy's label (DailyMed, Revised: 06/2026) covers weight management in adults and children 12 and older. Saxenda's also starts at 12, and Zepbound's covers adults only.

As of September 22, 2026, the day this article was written, the newest look below that line was a Pediatrics study published September 4, 2026 (Orandi et al.). Among more than 3.5 million U.S. children aged 8 to 11 with obesity and without diabetes, 0.6% had been prescribed Saxenda, Wegovy or Zepbound. Prescribing rose sharply from 2019 but stayed uncommon. The authors note that pediatric guidelines allow doctors to consider these drugs at those ages, so off-label can be a deliberate, guideline-backed choice.

Yes. FDA's page says that once a drug is approved, "healthcare providers generally may prescribe the drug for an unapproved use when they judge that it is medically appropriate for their patient." The agency approves products and polices how companies sell them. What one clinician decides for one patient is the practice of medicine. FDA's reasons are practical: there may be no approved drug for the condition, or the approved ones haven't helped.

The limit falls on the company, which may not promote a drug for uses the FDA hasn't approved. The textbook case is Neurontin (gabapentin), approved in 1993 only as an add-on epilepsy treatment. In 2004, Warner-Lambert agreed to plead guilty and pay more than $430 million over promoting it for bipolar disorder, pain, migraine and other unapproved uses, the Justice Department announced. A doctor may choose an off-label use. A drug company may not sell one.

How common is off-label prescribing, and is it riskier?

Very common. A national study of 2001 office-visit data on 160 commonly prescribed drugs found about 21% of their uses, roughly 1 in 5, were off-label (Radley et al., Archives of Internal Medicine, 2006). For gabapentin it was 83%. The less comfortable finding: about 73% of those off-label uses had little or no scientific support.

Evidence is what separates careful off-label prescribing from the rest. A Quebec study followed 46,021 primary-care patients through 151,305 new prescriptions (Eguale et al., JAMA Internal Medicine, 2016). Off-label uses without strong evidence had about a 54% higher rate of adverse drug events, meaning harmful reactions to a medicine, than on-label uses. Off-label uses with strong evidence had about the same rate as on-label ones.

So the better question isn't only "is this on the label?" It's "what's the evidence for this use, in someone like me?"

Off-label vs compounded vs unapproved

Off-label describes how an approved product gets used. It needs a product with a label to step outside of. The other two categories don't have one.

Term What it is Approved label? Example
Off-label An approved drug used outside its label Yes, and this use falls outside it Ozempic prescribed for weight loss alone
Compounded A preparation a licensed pharmacy makes for one patient on a prescription No, the preparation has none Compounded semaglutide
Unapproved A substance with no approved U.S. product No, and there never has been one BPC-157

Compounded is its own category, not off-label

FDA's compounding questions and answers (content current as of September 16, 2025) say compounded drugs are not FDA-approved, meaning the agency does not verify their safety, effectiveness or quality before they reach patients.

So compounded semaglutide isn't "off-label Ozempic." It's a different product with a dispensing label but no FDA-reviewed prescribing information of its own. Through Promise, semaglutide is dispensed as a compounded medication, which is different from an FDA-approved product: the formulation offered here is not FDA-approved. How compounded medications are made covers the pharmacy side.

Sermorelin is the in-between case, because it once had a label. Geref, a sermorelin injection for children with growth hormone deficiency, was approved in 1997; its maker asked for withdrawal, and the approval ended in 2009, not for reasons of safety or effectiveness, FDA later determined. Today no FDA-approved sermorelin product is marketed, and the compounded formulation offered here is not FDA-approved. Promise offers sermorelin by prescription after a licensed provider reviews your request. So a sermorelin prescription isn't off-label use either; there's no current label to depart from.

Unapproved means there is no FDA-reviewed prescribing information

BPC-157 has never had an approved product in the United States. No FDA-reviewed prescribing information, no approved dose, no approved use, so "off-label BPC-157" doesn't describe anything real. What governs it is compounding law, meaning which ingredients pharmacies may work with; that story, including the July 2026 advisory committee vote, is in are peptides legal. A drug being tested in a clinical trial sits in another lane again, explained in what an IND is.

Regulatory status is one input, not the whole decision. Where the rules allow a compounded formulation, a licensed provider may still prescribe it; that decision is between the patient and the doctor.

Mistakes people make about off-label meaning

"Off-label means illegal." It doesn't. It's an everyday, lawful part of prescribing. The restriction is on company marketing.

"A peptide with no approved product is prescribed off-label." With no FDA-reviewed prescribing information, there's no approved indication to be off. The accurate description is a compounded preparation of a substance that has never had an approved U.S. product.

"If the drug is approved, insurance will cover the off-label use." Not necessarily, which is why FDA's own list of questions includes asking about coverage. On-label coverage can change too: many insurers and employers now exclude GLP-1 medicines prescribed only for weight loss, as our report on insurers dropping GLP-1 coverage explains.

When an off-label use becomes on-label

A use moves onto the label when a company submits evidence and FDA approves it. For older, inexpensive drugs there may be little commercial reason to try.

As of September 22, 2026, the day this article was written, FDA was working on that gap. On May 11, 2026, the agency asked for public input on drug repurposing: new uses or new populations for drugs it has already approved, especially where the science exists but no company has a commercial reason to seek approval. Comments closed July 13, and a public workshop on choosing candidates was set for August 5, 2026. It is a request for information, not a list of label changes, and compounded products, which lack FDA-reviewed prescribing information of their own, sit outside it.

FDA tentative approval describes an application that has cleared scientific review but still faces a legal barrier to marketing. An IND opens human research on a drug that isn't approved yet, and Section 503A compounding covers a pharmacy preparing one patient's prescription. Off-label is the only one of these about how an approved, labeled drug gets used.

At Promise, a licensed provider reviews every request, and not everyone qualifies. That review asks the question good off-label prescribing asks: does the evidence support this, for this person?