Is the Compounded GLP-1 Shortage Over?

Yes. The FDA declared the tirzepatide shortage resolved on December 19, 2024 and the semaglutide shortage resolved on February 21, 2025, and the grace periods it gave compounders all expired in the spring of 2025. As of September 21, 2026, neither drug is on the FDA’s shortage list, and the shortage is no longer a lawful basis for compounding either one.

That matters more than it sounds, because the shortage was the legal mechanism that made compounded GLP-1s widely available in the first place. It is gone. Compounded semaglutide and tirzepatide are still lawfully prescribed, but through a narrower route that depends on your prescriber rather than on a supply designation, and a lot of what you read online has not caught up.

One thing stays true throughout, and it was true during the shortage too: compounded medications are not FDA-approved. The agency does not review them for safety, effectiveness or quality before a patient receives them, and they are not generic or equivalent versions of Wegovy, Ozempic, Zepbound or Mounjaro. Anyone who tells you otherwise is describing something that does not exist.

The timeline

Every one of those dates comes from the FDA’s own statements, listed in full at the bottom of this page. Three details in that table are routinely reported wrongly, including by sources that should know better.

The 503A end dates were not the announced ones. Almost every summary you will read gives February 18 and April 22, 2025. Those were the dates FDA first announced, but the agency then tied the periods to pending litigation: they ran to the announced date or the district court’s ruling, whichever was longer. The same later-of-court-decision framework applied to both categories, not just 503A. The court ruled on March 5 for tirzepatide and April 24 for semaglutide, so those are the dates 503A enforcement discretion actually ended. The 503B dates, March 19 and May 22, were the later of the two in each case, so they are the dates that applied there.

The tirzepatide shortage was declared resolved twice, in October 2024 and again in December 2024 after a court remanded the question for re-evaluation. The December decision is the one the wind-down ran from.

The 2026 comment period was extended by 30 days, so it closed on July 30, 2026, not in June.

What actually changed

While a drug is on the FDA shortage list, it is not treated as commercially available, and the usual restriction on compounding copies of commercially available drugs does not bite. That is why compounded GLP-1s appeared at scale in 2023 and 2024. It was not a loophole anyone was hiding; it was the rule working as written.

Once the shortages resolved, that route closed on a schedule. State-licensed 503A pharmacies got 60 days and 503B outsourcing facilities got 90 days from each announcement. Compounders challenged the shortage determinations in federal court, and FDA tied the 503A periods to the outcome: they ran to the announced date or the court’s ruling, whichever was longer. The court declined to block the determinations in both cases, on March 5 and April 24, 2025, and those rulings are what actually closed the 503A route.

What remains is an exception written into the statute itself. Under Section 503A of the Federal Food, Drug and Cosmetic Act, a compounded preparation is not an essentially-a-copy product where a change made for an identified individual patient produces, for that patient, a significant difference from the commercially available drug, as determined by the prescribing practitioner. FDA guidance says that determination should be documented on the prescription.

Read plainly, the weight moved from a supply designation onto your prescriber and the record they keep. That is the honest summary, and it is worth knowing what to ask about as a result.

That exception is also not the whole of the law. It settles one question — whether a preparation counts as essentially a copy of an available product — and the other conditions of Section 503A still apply on top of it, including that the preparation is for an identified individual patient on a valid prescription and that the ingredients meet the statute’s requirements.

The picture is different for 503B outsourcing facilities, and not in the way it is usually described. A 503B outsourcing facility may obtain prescriptions for identified patients or supply medications without individual prescriptions. Section 503B(d)(2)(B) includes a patient-specific clinical-difference provision, but it does not override the separate restriction on identical or nearly identical copies in section 503B(d)(2)(A). What closes the route for compounded GLP-1s at a 503B facility is a separate condition again. An outsourcing facility may not compound from a bulk drug substance unless that substance is on the FDA’s 503B bulks list or the drug is on the shortage list at the time, and the FDA states that tirzepatide and semaglutide appear on neither. A prescription does not change that.

What this means if you are on a compounded prescription now

The 2025 expiries changed the basis on which a compounded prescription can be written. They are not a determination about any individual prescription, and this page cannot tell you whether yours was or remains appropriate. That is a question for the prescriber who wrote it, and it is worth raising about your current preparation and about future refills.

Three things are worth checking, and they are all things you can verify yourself:

1. Ask your prescriber what the clinical reason is for a compounded preparation rather than the approved product, and whether it is documented on the prescription.
2. Ask which pharmacy fills it, by name, and under which section it operates. A 503A pharmacy is state-licensed and compounds for one named patient at a time; a 503B outsourcing facility registers with the FDA and may compound without a named patient.
3. Verify the prescriber’s licence in your state. Every state medical board runs a free public lookup, and it is the record that shows current status, restrictions and any public disciplinary action. A national provider identifier is not a substitute: it identifies a clinician but does not establish licensure.

If your provider treats any of those three questions as friction, that is information.

What is still open

On April 30, 2026 the FDA proposed excluding semaglutide, tirzepatide and liraglutide from the 503B bulks list, the list of substances outsourcing facilities may compound from in bulk, on the basis that there is no clinical need for them when approved products are available. The comment period closed on July 30, 2026 after a 30-day extension, and the agency had not published a final determination when this page was last verified on September 21, 2026.

Two things about that proposal get overstated. It concerns 503B outsourcing facilities compounding from bulk substances, not 503A pharmacies filling patient-specific prescriptions. And a proposal is not a rule. If you have read a headline saying compounded GLP-1s have been banned, they have not been. The room is narrower than it was in 2024, and it may narrow again.

The safety warnings worth knowing

Two FDA warnings sit alongside the legal picture, and neither is about the legal question.

Salt forms. The FDA has said that semaglutide sodium and semaglutide acetate are different active ingredients from the one in the approved drugs, and that it is not aware of any lawful basis for their use in compounding. If you are being offered “semaglutide sodium” or “semaglutide acetate”, that is a different substance from what is in the approved products, and you should ask directly which form your prescription uses.

Dosing errors. The FDA has received multiple reports of adverse events, some requiring hospitalisation, that may be related to dosing errors with compounded injectable semaglutide. The errors it describes are of a particular kind: patients measuring and self-administering the wrong amount, health care professionals miscalculating a dose, and products prescribed at higher single doses or faster titration schedules than the approved labelling supports. The FDA does not publish a count of dosing-error reports specifically.

Adverse event reports generally. Separately, as of May 31, 2026 the agency had received 990 reports of adverse events associated with compounded semaglutide and more than 730 associated with compounded tirzepatide. Three things the FDA says about those numbers travel with them. Many of the reported events appear consistent with those reported for the approved versions. It is not always possible to tell whether the drug caused the event. And because state-licensed pharmacies that are not outsourcing facilities are not required to report to the FDA at all, the agency expects these are undercounts. They are reports, not a rate, and not a finding of causation.

Compounded products arrive in different concentrations and formats from the approved pens, so the number on someone else’s instructions is not the number on yours. Check that you can state your dose, the volume that corresponds to it, and the interval, and ask again if you cannot.

Where we stand

Gentle Health prescribes compounded semaglutide and tirzepatide, so this page describes the rules we operate under, and it is fair to say plainly what that means. Every prescription in every state we serve is written by James Simmons, MD, who personally reviews each intake and decides whether treatment is appropriate. Our prescriptions are filled by state-licensed US pharmacies compounding under Section 503A. What we dispense is not FDA-approved, and we will not describe it as equivalent to a brand-name product, because it is not.

We would rather you check that than take it from us. Dr. Simmons’s licence is verifiable today in any state we serve: our states page links to each state’s own page, which carries his licence number for that state and a direct link to that state’s medical board lookup. His national provider identifier, 1215498332, is a separate thing and worth naming as such — it identifies him in the federal registry but is not a licence and does not establish that he is licensed anywhere, which CMS says explicitly. The board record is the one that answers that question. This page does not list our pharmacies’ licence numbers or testing records; you can still search either pharmacy by name in your state’s board of pharmacy database, or ask us for the exact legal name and number.

The wider regulatory pattern this year, including what the FTC and FDA have been acting on, is covered in the 2026 telehealth enforcement wave. What the no-prescription market actually sells is covered in where GLP-1 medication online comes from. The rest of the question library is at GLP-1 questions.

Frequently asked questions

Is compounded semaglutide still legal in 2026? Compounding it is still lawful in defined circumstances, and narrower ones than during the shortage. The shortage basis ended in spring 2025. Under Section 503A, compounding drug products that are essentially copies of a commercially available product, regularly or in inordinate amounts, is restricted; the statute’s exception is a change made for an identified individual patient that the prescribing practitioner determines produces a significant difference for that patient, and every other condition of Section 503A applies alongside it. Whether any particular prescription meets those conditions is not something a page like this can tell you.

Did the FDA ban compounded GLP-1s? No. The FDA declared the shortages resolved, which closed the shortage route, and in April 2026 it proposed excluding semaglutide, tirzepatide and liraglutide from the 503B bulks list. That proposal covers outsourcing facilities compounding from bulk substances, it is not final as of September 21, 2026, and it is not a ban on compounded GLP-1 prescribing.

Do I have to switch to the brand-name drug now that the shortage is over? That is a decision for you and your prescriber, not one this page can make. FDA determined that supply could meet national demand, but local supply interruptions can still occur; the basis for compounding changed in 2025. Ask your prescriber about your current preparation and about future refills rather than acting on a regulatory date.

Sources

• FDA, “FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize” — https://www.fda.gov/drugs/drug-alerts-and-statements/fda-clarifies-policies-compounders-national-glp-1-supply-begins-stabilize — page last updated April 1, 2026, carrying the dated updates of February 11 and March 10, 2025, and carrying in its body the resolution dates of December 19, 2024 and February 21, 2025 and the court dates of April 22 and April 24, 2025. Source of every shortage resolution date, both enforcement discretion periods, and the two district court rulings. Verified September 21, 2026
• FDA, “FDA Proposes to Exclude Semaglutide, Tirzepatide, and Liraglutide on 503B Bulks List” — https://www.fda.gov/news-events/press-announcements/fda-proposes-exclude-semaglutide-tirzepatide-and-liraglutide-503b-bulks-list — April 30, 2026. A proposal; verified still not final on September 21, 2026
• Federal Register, “List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B; Extension of Comment Period”, June 26, 2026, docket FDA-2018-N-3240 — comment period extended to July 30, 2026
• FDA, “FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss” (fda.gov), page last updated September 1, 2026 — salt forms, dosing errors, and adverse event report counts as of May 31, 2026
• FDA guidance for industry, Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the FD&C Act — the prescriber-determination and documentation standard
• FDA, FD&C Act provisions that apply to human drug compounding — https://www.fda.gov/drugs/human-drug-compounding/fdc-act-provisions-apply-human-drug-compounding — the full set of conditions each section requires
• Section 503A of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 353a

Dr. James Simmons, MD