The GLP-1 compounding ban is not one law. It is the result of FDA declaring the tirzepatide shortage over on December 19, 2024 and the semaglutide shortage over on February 21, 2025, followed by grace periods that ended between March and May 2025.[1] Since then, pharmacies generally may not make copies of Mounjaro, Zepbound, Ozempic or Wegovy, and on August 27, 2026 a federal appeals court upheld FDA’s decisions.[4][5]
For the shortage itself, see our guide to the GLP-1 drug shortage. For drug-specific detail, see compounded semaglutide vs Ozempic and compounded tirzepatide, and our GLP-1 basics hub.
Why compounding was allowed, and why it stopped
Compounded drugs are exempt from FDA approval only if they meet Section 503A or 503B of the FD&C Act:[1]
- 503A pharmacies may not regularly make drugs that are essentially copies of a commercially available drug. A drug on FDA’s shortage list doesn’t count as commercially available.
- 503B outsourcing facilities may compound from a bulk ingredient only if it is on the 503B bulks list or the drug is on the shortage list.
Neither semaglutide nor tirzepatide is on the 503B bulks list, so the shortage was the legal basis for mass compounding. Once FDA removed the drugs from the shortage list, that basis disappeared.[1] See 503A vs 503B compounding for the full comparison.
Grace period dates
FDA gave compounders time to wind down rather than ending compounding overnight.[1][2][3]
| Tirzepatide | Semaglutide | |
|---|---|---|
| Shortage declared resolved | Dec 19, 2024 (first Oct 2, 2024) | Feb 21, 2025 |
| Original 503A deadline | Feb 18, 2025 | Apr 22, 2025 |
| 503A discretion actually ended | After Mar 5, 2025 court ruling | After Apr 24, 2025 court ruling |
| 503B deadline | Mar 19, 2025 | May 22, 2025 |
FDA extended the 503A deadlines to the later of the original date or the court’s ruling on the compounders’ requests for preliminary injunctions.[1] Even during grace periods, FDA said it could still act against substandard or unsafe products.[3]
The OFA lawsuits and rulings
The Outsourcing Facilities Association (OFA), a trade group, and a Texas compounder challenged both decisions in the U.S. District Court for the Northern District of Texas.
- Tirzepatide: after OFA sued over the October 2024 decision, FDA reevaluated and issued a new order on December 19, 2024 that replaced the first one.[2] The court denied a preliminary injunction on March 5, 2025.[1]
- Semaglutide: the court denied a preliminary injunction on April 24, 2025 and later granted summary judgment to FDA.[1][5]
- Fifth Circuit, August 27, 2026: in two unpublished opinions, the appeals court affirmed both judgments. It held that any error from not using notice-and-comment procedures was harmless, because the compounders had actual notice and chances to submit evidence, and that FDA’s reliance on manufacturer supply data was not arbitrary or capricious.[4][5]
Unpublished Fifth Circuit opinions are generally not binding precedent, but they leave FDA’s shortage decisions in place. We found no report of a further appeal as of mid-October 2026.
FDA enforcement since the grace periods
| Date | Action |
|---|---|
| Sept 9, 2025 | FDA launched a crackdown on deceptive drug advertising, with thousands of letters and about 100 cease-and-desist letters[11] |
| Feb 6, 2026 | FDA said it would restrict GLP-1 ingredients used in mass-marketed compounded drugs and could seek seizure or injunction without further notice[6] |
| Mar 3, 2026 | Warning letters to 30 telehealth companies over compounded GLP-1 marketing[7] |
| Apr 1, 2026 | FDA reminded compounders that tirzepatide and semaglutide are on neither the shortage list nor the 503B bulks list[1] |
| Apr 30, 2026 | FDA proposed excluding semaglutide, tirzepatide and liraglutide from the 503B bulks list[8] |
FDA has also issued a “green list” import alert to stop GLP-1 ingredients with possible quality problems, and warning letters to ingredient distributors and to sellers labeling GLP-1s “for research purposes.”[10] It says companies may not market compounded drugs as generics, as having the same active ingredient as approved products, or as clinically proven.[6]
What’s still allowed
The rules leave narrow room:
- Significant difference: a 503A pharmacy may compound a version with a change that a prescriber determines and documents produces a significant difference for an identified patient.[1]
- Low volume: FDA says it generally won’t act against a 503A compounder that fills four or fewer prescriptions of an essentially-copy drug in a calendar month.[1]
- Not a loophole: FDA treats a product with the same ingredient at a similar strength as a copy even if a vitamin is added; its example is semaglutide with B12 at strengths within 10% of the approved product.[1] See compounded GLP-1 additives.
If you were using a compounded GLP-1
Many people started compounded semaglutide or tirzepatide during the shortage. If your supply has changed, these steps can help:
- Don’t stop abruptly without a plan. Talk to your prescriber about moving to an approved product or another option. See stopping GLP-1s for what to expect.
- Don’t convert doses yourself. Compounded vials are often measured in units on an insulin syringe, while approved pens dial milligrams. FDA has received reports of dosing errors from these conversions.[10] Your clinician should choose the starting dose of any new product; the GLP-1 dose conversion chart explains why there is no simple formula.
- Ask your pharmacy directly whether it compounds under 503A or 503B, what the active ingredient form is, and on what basis it is still making the drug.
- Report problems. Side effects from any drug, compounded or not, can be reported to FDA’s MedWatch program.
A product sold as “for research purposes” or “not for human consumption” is not a compounded drug at all, and FDA has sent warning letters to sellers of GLP-1s labeled that way.[10]
What’s next
- 503B bulks list decision: the proposal was published in the Federal Register on May 1, 2026, and FDA said it would consider comments before deciding.[9][8] If finalized, outsourcing facilities could not compound these drugs from bulk unless they return to the shortage list.
- Liraglutide: still on FDA’s shortage list in October 2026, so it is the one GLP-1 where the shortage pathway remains formally open.
- More enforcement: FDA has signaled further warning letters and possible court action against firms that mass-market copies.[6]
- New shortages: if a GLP-1 returns to the shortage list, the compounding rules would change again.
If cost drove you to compounded drugs, see GLP-1 cost without insurance and GLP-1 alternatives.
This is general information, not legal advice. Talk to your prescriber before changing or stopping any medication.
