THE SHORT ANSWER: Compounded versions of semaglutide and tirzepatide are being phased out, and the legal window for getting them is closing fast. Tirzepatide came off the FDA's drug shortage list in December 2024, and semaglutide followed in February 2025. Once a drug leaves the shortage list, compounding pharmacies lose the legal basis they were using to make copies of it. Grace periods for winding down expired in 2025, and the FDA is now proposing to permanently exclude semaglutide, tirzepatide, and liraglutide from the list of substances outsourcing facilities can compound at all, regardless of future shortages. A narrow exception still exists for individual 503A pharmacies compounding for a documented allergy or a dose strength that isn't commercially available, but routine compounded copies as a cheaper alternative to the approved drug are no longer legal. If you're currently on a compounded version, this is worth understanding before your next refill.
What actually changed, and when
For a few years, compounded semaglutide and tirzepatide were a legal and common option, because both drugs were on the FDA's drug shortage list. Federal law allows 503A and 503B compounding facilities to produce copies of an FDA-approved drug specifically when that drug is in shortage. That's the loophole that made large-scale compounded GLP-1 production possible in the first place.
That loophole closed in stages. Tirzepatide was removed from the shortage list in December 2024. Semaglutide followed in February 2025. Once a drug comes off the shortage list, the legal basis for compounding a copy of it disappears immediately in principle, but the FDA allowed phased enforcement deadlines so pharmacies could wind down existing operations rather than stopping overnight. Those grace periods expired in 2025. As of now, compounded GLP-1s that are essentially copies of the FDA-approved versions are not legally permitted, and enforcement has continued despite legal challenges from industry groups representing outsourcing facilities.
The FDA isn't stopping at the shortage list
Here's the part that signals this isn't temporary. The FDA has proposed going further and permanently excluding semaglutide, tirzepatide, and liraglutide from the list of bulk substances that 503B outsourcing facilities are allowed to compound from, under any circumstances, even during a future shortage. A public comment period on that proposal is open through June 29, 2026. If finalized, this closes the door completely for the largest-scale compounders rather than leaving it open for the next time one of these drugs runs short.
What's still actually legal
The exceptions that remain are narrow and specific, not a workaround for cost or convenience. For 503A pharmacies, which compound in smaller batches typically tied to an individual prescription, compounding is still permitted when a patient has a documented allergy to an excipient in the approved product, or needs a dose strength that isn't commercially manufactured. A prescriber might also have a legitimate reason to request an alternative formulation, like an oral or sublingual version, when there's a real medical justification. What isn't a legitimate basis anymore is compounding a copy of the approved injectable simply because it's less expensive or more available than the brand product.
What this means if you're currently on a compounded version
If you're currently using a compounded semaglutide or tirzepatide product, the honest picture is that your access to it is either already restricted or likely to become more restricted as enforcement continues. Some patients are still receiving compounded versions even as commercial supply has stabilized, but that's increasingly the exception rather than the norm, and it's not a stable long-term plan. Transitioning to an FDA-approved product typically means a new prescription, a dose adjustment since compounded and brand-name dosing schedules don't always match exactly, and dealing with insurance coverage, which varies significantly by plan.
The safety consideration matters here too, separate from the legal one. Compounded medications have not gone through the FDA's clinical trial and manufacturing review process the way the approved products have. That doesn't automatically mean a given compounded product is unsafe, but it does mean there's less independent verification of potency, purity, and consistency from batch to batch, which is part of why the regulatory framework treats compounding as an exception rather than an equivalent alternative.
Where retatrutide fits, and why it's a different situation entirely
It's worth being precise here, because these two things get confused constantly. Retatrutide is not a compounded copy of an approved drug. It's an investigational triple agonist that has not completed the FDA approval process for any indication. The shortage-list rules discussed above don't apply to it, because those rules govern compounding copies of already-approved medications. Retatrutide's regulatory situation is its own category: an unapproved compound that is not yet legally available as a finished, marketed drug outside of clinical trials and appropriately structured clinical access.
At Vitality Dartmouth, where retatrutide is offered, it's available only to appropriately screened candidates under provider prescription and physician-supervised oversight, following a full intake and lab workup, with its investigational status disclosed. That's a different model from a compounding pharmacy producing bulk copies of an approved drug to sidestep a shortage. Neither situation should be confused with the other, and if a program can't clearly explain which category a medication falls into, that's worth asking about directly.
How we approach this at Vitality Dartmouth
We prescribe FDA-approved semaglutide and tirzepatide through standard pharmacy channels when those are the right fit for a client, rather than relying on compounded copies whose legal footing has been steadily narrowing.
We track the regulatory landscape as part of how we advise clients, since the rules around compounding have changed multiple times in the past two years and are still moving, including the pending permanent 503B exclusion proposal.
We're direct about what category any medication we discuss falls into, whether that's an FDA-approved product, a legitimate 503A compound for a documented medical need, or an investigational compound like retatrutide offered only to screened, monitored candidates.
We pair any GLP-1 therapy with the same lab monitoring and genomic testing we use across our metabolic programs, regardless of which specific medication or formulation a client is on.
Frequently asked questions
Is compounded semaglutide illegal now?
Compounding a copy of the FDA-approved product is no longer legally permitted for routine use, since both semaglutide and tirzepatide have been off the FDA shortage list since early 2025 and their grace periods have expired. Narrow exceptions remain for documented allergies or unavailable dose strengths through 503A pharmacies.
What should I do if I’m currently on a compounded GLP-1?
Talk with your prescribing provider about transitioning to an FDA-approved product. Expect a new prescription, a possible dose adjustment, and a look at your insurance coverage, since compounded and brand-name products aren’t priced or covered the same way.
Is retatrutide compounded?
No. Retatrutide is an investigational medication, not a compounded copy of an approved drug, and the shortage-list compounding rules don’t apply to it. Where it’s offered, it should come with full disclosure of its investigational status and real clinical screening.
Do you help patients transition off compounded GLP-1s near me?
Yes. Vitality Dartmouth is based in Dartmouth, MA, and works with clients across the SouthCoast, including New Bedford, Westport, Fairhaven, and Fall River, with RN-supervised care built around your actual prescription history and labs.
The compounded GLP-1 era that many patients got used to over the past few years is winding down, and the FDA's newest proposal suggests it isn't reopening even if a future shortage occurs. If you're on a compounded version, this is a reasonable time to have a real conversation with your prescriber about what's next, rather than waiting for access to become a bigger problem later.
This article is for educational purposes only and is not medical advice. Regulatory status, prescribing rules, and compounding regulations change over time and vary by state and pharmacy type. Discuss your specific medication, prescription, and any transition plans with a licensed healthcare provider or pharmacist.