FDA 2026: excluding semaglutide and tirzepatide from 503B bulks
In early 2026 the FDA finalized the exclusion of semaglutide and tirzepatide from the 503B "interim bulks list" — the regulatory mechanism that let outsourcing facilities compound them at scale during the recent shortages. That door is now mostly closed, and the supply landscape for compounded GLP-1s has changed sharply.
The two compounding pathways
U.S. compounding splits into two regulatory tracks:
| Section | Type of facility | Who they can compound for | Bulk sourcing rules |
|---|---|---|---|
| 503A | Traditional pharmacies (state-licensed) | Specific patient with a prescription | Limited; must follow USP guidelines |
| 503B | Outsourcing facilities (FDA-registered) | Provider offices, bulk batches without patient names | Allowed only from FDA-approved bulks list (or shortage list) |
What changed in 2024–2026
- 2022–2023: Both semaglutide and tirzepatide on FDA's shortage list. 503B facilities legally compound from API.
- October 2024: FDA removes tirzepatide from the shortage list; February 2025 removes semaglutide.
- 2025: Compounders shift to the "interim bulks" pathway — drugs added to the 503B bulks list pending evaluation.
- 2026: FDA finalizes exclusion of both from the bulks list. 503B facilities can no longer compound either at scale.
What is still legal
The change targets 503B outsourcing facilities, not 503A traditional pharmacies. A licensed 503A pharmacy can still compound semaglutide or tirzepatide for a specific patient with a prescription, in a clinical situation that justifies it. Examples FDA recognizes as legitimate compounding triggers:
- Documented allergy to an excipient in the FDA-approved product.
- Dose strength not available in commercial form.
- Pediatric or unusual delivery requirement.
What does not qualify: "I want it cheaper" or "I want a non-standard dose for convenience." A 503A pharmacy that compounds without a real clinical justification — or at scale without individual prescriptions — is operating outside its license.
What the compounded-GLP-1 market actually looks like now
Three groups remain in the market:
- Legitimate 503A pharmacies compounding small volumes for clinically-justified individual patients. Expensive, slow, prescriber-relationship dependent.
- "Research-use-only" peptide vendors selling under that label without licensure. Operating outside the FDA framework. Legal exposure for both seller and buyer is non-trivial. See the post on why "research use only" is not a legal disclaimer.
- Counterfeit pen sellers on grey-market platforms. Outright illegal; quality and content unverifiable.
What this means for your supply
If you were buying compounded semaglutide or tirzepatide through a telehealth → 503B channel in 2024–2025, that pipeline is largely closing. Three things to do:
- Confirm your pharmacy's license type. A 503A traditional pharmacy with a clear patient-specific workflow is on stable ground; an outsourcing-style operation is not.
- Expect price changes. 503A compounding is more expensive than 503B was; many patients will end up either back on the approved product or off the drug entirely.
- Avoid grey-market suppliers. The concentration and identity issues are now your problem, not a regulator's.
FAQ
Is compounded semaglutide now illegal?
Not categorically. 503A pharmacies can still compound it for a specific patient with documented clinical justification. What's mostly ended is 503B mass-compounded supply for clinic distribution.
Can my doctor still prescribe compounded semaglutide?
Yes, if they identify a clinical reason and a 503A pharmacy that's willing to fill it. The bar is "specific patient need," not "preference" or "cost."
What about compounded GLP-1 still being shipped from "compounding pharmacies"?
Examine the license type. If it's a 503B outsourcing facility, the supply they're shipping is now problematic. If it's a 503A operating at obvious scale, the model isn't aligned with the law.
Is there a path back to compounded supply if shortages return?
Yes — re-listing on the FDA shortage list would re-open 503B compounding. The path forward depends on Novo Nordisk and Eli Lilly's manufacturing capacity.
Related reading
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Get the iPhone app →Informational and educational only. Not medical advice. Consult a licensed clinician before starting, changing, or stopping any peptide protocol. Mentions of investigational, compounded, or research-use peptides are for informational purposes; many such substances are not FDA-approved for human use.