For roughly two years, compounded semaglutide and tirzepatide were the backbone of medical weight-loss programs at med spas and wellness clinics. That was possible because both drugs were on FDA’s shortage list, which opens a compounding pathway that is otherwise closed.
Both shortages have been resolved, the enforcement grace periods have expired, and FDA has moved to close the door further. Here is the timeline and where it leaves an operator.
What the shortage listing did
Federal law generally prohibits compounding a drug that is “essentially a copy” of a commercially available FDA-approved product. A shortage listing changes that: while a drug is in shortage, compounders may prepare versions of it to meet patient need.
That is the mechanism that built the compounded GLP-1 market. It was never a permanent permission. It was a shortage response, and it lasted only as long as the shortage.
The timeline
| Date | What happened |
|---|---|
| October 2, 2024 | FDA removed tirzepatide from the shortage list. On October 22 the decision was sent back to FDA for reevaluation |
| December 19, 2024 | A new FDA order found the tirzepatide shortage resolved, replacing the October decision |
| February 21, 2025 | FDA determined the semaglutide shortage was resolved |
| March 5 and March 19, 2025 | Tirzepatide grace periods ended for 503A pharmacies and 503B outsourcing facilities |
| April 24, 2025 | Semaglutide grace period ended for 503A pharmacies. FDA had set April 22 or the date of the court’s ruling, whichever was later, and the court denied an injunction on April 24 |
| May 22, 2025 | Semaglutide grace period ended for 503B outsourcing facilities |
| 2025 | Industry legal challenges failed to secure preliminary injunctions |
| April 30, 2026 | FDA proposed excluding semaglutide, tirzepatide and liraglutide from the 503B bulks list, finding no clinical need (91 FR 23431, published May 1, 2026). Comments closed July 30, 2026, and no final action had been published as of September 2026 |
The proposal in April 2026 is the significant one. Excluding these substances from the 503B bulks list would remove the remaining route for outsourcing facilities to compound them from bulk drug substance, and the finding underpinning it is that there is no clinical need to do so now that the approved products are available.
Where that leaves compounding today
Broad compounding of semaglutide and tirzepatide as shortage replacements has ended. A 503B outsourcing facility has no bulk pathway for either drug. A 503A pharmacy may compound a copy of a commercially available drug only in small numbers: FDA’s enforcement policy is not to act at four or fewer copy prescriptions of a product in a calendar month.
A compounded product is also not a copy where the prescriber determines that a change produces a significant difference for an identified patient and records that on the prescription. A lower price never qualifies. That is a genuine clinical determination made for an individual, documented for that patient.
It is not a business model. A program built on routinely compounding these drugs for every patient is not operating within that narrow space, whatever the pharmacy’s marketing says.
The questions to ask your pharmacy
- Under what specific basis are you compounding this today, post-delisting?
- Is this patient-specific, and what significant difference does the prescription document for that patient?
- Are you compounding from bulk drug substance, and on what listing?
- Have you received any FDA correspondence about these products?
A vague answer is an answer. “Everyone is still doing it” is not a legal basis, and it will not be a defense.
What operators should actually do
- Know what you are dispensing. Many practices genuinely do not know whether their supply is branded, patient-specific compounded, or something else.
- Fix the marketing. Pages written during the shortage often still advertise compounded GLP-1s as a standing offer.
- Do not substitute silently. Advertising a branded drug and dispensing a compounded alternative is a problem on multiple fronts.
- Rebuild the economics. Programs priced against compounded costs may not survive a shift to branded products. It is better to model that deliberately than discover it.
- Do not chase the next unapproved molecule. The market response to this tightening has been a migration toward substances with no approval pathway at all, which is a worse position, not a better one.
The value is not the molecule
Practices that treated compounded GLP-1s as a cheap product to resell are struggling. Practices that built an actual clinical program (evaluation, labs, monitoring, dose management and follow-up) are largely fine, because what they sold was the program.
Patients did not stay because the semaglutide was compounded. They stayed because someone was paying attention to their results. That is portable across whatever the supply picture does next.
How MDside handles this
We maintain documented 503A and 503B pharmacy relationships and confirm the basis on which anything is supplied, keep protocols current as the regulatory picture moves, and build programs around evaluation, labs, and monitoring rather than around a single product.
See what is included, or read about 503A and 503B sourcing.
Related reading
Frequently asked questions
Is compounded semaglutide still legal in 2026?
Broad shortage-based compounding has ended. A 503A pharmacy may still compound for a named patient where the prescriber documents a significant difference, or in small numbers under FDA’s four-a-month policy. Routine compounding as a program default sits outside both.
When did the shortages end?
FDA found the tirzepatide shortage resolved on December 19, 2024, replacing an October 2, 2024 decision that had been sent back for reevaluation. The semaglutide shortage was found resolved on February 21, 2025.
What happened to the enforcement grace period?
For semaglutide, it ended April 24, 2025 for 503A pharmacies and May 22, 2025 for 503B outsourcing facilities. For tirzepatide, it ended March 5, 2025 for 503A pharmacies and March 19, 2025 for 503B outsourcing facilities.
My pharmacy says it is still fine. Is it?
Ask for the specific basis in writing. A supplier’s confidence is not a legal position, and the practice administering the product carries its own exposure.
What should I offer instead?
Approved products, prescribed after a real evaluation, inside a monitored program. That is a defensible offering and a more durable business than arbitraging a supply gap.
General information about compounding regulation, not legal or clinical advice. This area is actively changing, including a pending FDA proposal with a public comment process. Verify current status and confirm with healthcare counsel and your pharmacy.