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ForumsCompounding & FormulationBeyond-use dating for compounded peptides — need advice

Beyond-use dating for compounded peptides — need advice

cory_ATX Fri, Dec 26, 2025 at 7:12 PM 12 replies 727 viewsPage 1 of 3
cory_ATX
Member
456
2,123
Jul 2024
Austin, TX
Dec 26, 2025 at 8:37 PM#1

Can someone give me a current state of affairs on compounded tirzepatide as of Q1 2026? It feels like the landscape changes every week.

Last I heard, FDA removed tirzepatide from the shortage list in late 2024 and has been going after compounders. But I'm still seeing some pharmacies advertising it. What's the actual legal status? And what are people paying?

44 2Dr.EndoEP, GraceAZ_72, carl_compliance and 41 others
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PharmHunterJen
Member
567
2,345
Jul 2024
Illinois
Dec 26, 2025 at 8:54 PM#2

Here's the current status as of March 2026:

Legal status: Complicated. FDA removed tirzepatide from the shortage list in October 2024 and has been issuing warning letters and cease-and-desist orders to compounders. HOWEVER, multiple lawsuits are challenging these enforcement actions, and some pharmacies have obtained temporary restraining orders allowing them to continue compounding.

Availability: Reduced but not eliminated. Several 503B facilities stopped voluntarily. Others are still compounding under legal protection from court orders. Some 503A pharmacies argue they're exempt from the enforcement because they compound on a patient-specific basis.

Pricing (where available):

  • Compounded tirzepatide 10mg vial: $150-275/month
  • Compounded tirzepatide 30mg vial: $300-450 (multi-month supply at lower doses)

Compare to brand Mounjaro/Zepbound at $1,050-1,200/month without insurance.

5 21alex_tucson, kevin_tulsa, Dr.PainCLE and 2 others
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carlos_SATX
Member
245
1,123
Oct 2024
San Antonio, TX
Dec 26, 2025 at 9:11 PM#3

The key legal case right now is the litigation in the 5th Circuit involving the Outsourcing Facilities Association. The core argument is whether compounded tirzepatide using a different salt form constitutes an "essentially a copy" of branded Mounjaro/Zepbound. If the courts rule it's NOT a copy, compounding could resume broadly.

There's also a constitutional argument about FDA overreach in enforcement. Some pharmacies argue that FDA's administrative determination that the shortage ended is arbitrary and capricious because patients still can't access the medication due to cost.

It's a legal mess. But the practical takeaway: compounded tirzepatide is still available from some pharmacies, just fewer than before.

29 24Dr.BariatricHTX, LindaRN_retired, tommy_boulder and 26 others
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LabKate
Senior Member
2,678
11,234
Jan 2024
Oregon
Dec 26, 2025 at 9:28 PM#4

So if I find a pharmacy still compounding it, am I taking any legal risk as a patient? Can FDA come after me for buying it?

24 22emily_PDX, Dr.SleepRoch, laura_annarbor and 21 others
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wendy_avl
Member
245
1,123
Oct 2024
Asheville, NC
Dec 26, 2025 at 9:45 PM#5

No. FDA enforcement actions target pharmacies and prescribers, not patients. You are not breaking any law by filling a valid prescription for a compounded medication. The legal risk sits entirely with the pharmacy and potentially the prescriber.

That said, availability risk is real. If your pharmacy gets shut down mid-treatment, you're back to square one (see the "pharmacy shut down" thread).

32 6RickReta_CO, PharmHunterJen, TomTeleRx and 29 others
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