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ForumsBuyer Beware⚠ Amino Asylum raided by FDA June 2025 — need advice

⚠ Amino Asylum raided by FDA June 2025 — need advice

Dr.AddMedPHL Fri, Sep 5, 2025 at 9:42 PM 14 replies 1,084 viewsPage 1 of 3
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Dr.AddMedPHL
Senior Member
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Mar 2024
Philadelphia, PA
Sep 5, 2025 at 11:07 PM#1

FDA just dropped updated enforcement guidance on March 10, 2026. I've read through the 47-page document so you don't have to. Here's the TL;DR:

  1. Semaglutide remains on the shortage list — compounding is still permitted under section 503A and 503B
  2. Tirzepatide was removed from the shortage list in late 2024 — FDA has been actively enforcing against compounders still making it, though legal challenges continue
  3. New emphasis on "essentially a copy" — FDA is cracking down on compounded products that are essentially copies of commercially available drugs when there's no shortage
  4. State-level enforcement cooperation — FDA announced partnerships with 12 state boards for coordinated inspections

The big takeaway: if you're using compounded semaglutide, you're probably fine for now. If you're using compounded tirzepatide, the legal landscape is murky and getting murkier.

1 23FitDadDave
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andrew_nyc
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Apr 2024
New York, NY
Sep 5, 2025 at 11:24 PM#2

the summary above is solid but I want to add legal context. The "essentially a copy" doctrine is being challenged in multiple federal courts right now. The Outsourcing Facilities Association filed suit arguing that compounded semaglutide using different salt forms (like semaglutide sodium vs. semaglutide base used in Ozempic) are NOT essentially copies.

This matters because if the courts agree, compounding could continue even after the shortage resolves. Several cases are working through the 5th Circuit right now.

Not legal advice, obviously. But worth tracking. ⚖️

7 7Dr.NateNeph, PharmD_Rodriguez, julia.endo and 4 others
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KevinCompounds
VIP Member
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Dec 2023
Nevada
Sep 5, 2025 at 11:41 PM#3

So what happens to those of us currently on compounded sema if the shortage ends? Do we just... lose access? I can't afford $1,200/month for brand Wegovy. The compounded version is literally the only reason I can afford treatment.

42 5MikeKY_noInsulin, Dr.RaviCardio, jennifer_SEA and 39 others
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DanielChem_CHI
Senior Member
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5,678
Mar 2024
Chicago, IL
Sep 5, 2025 at 11:58 PM#4

if the shortage officially ends and the "essentially a copy" argument doesn't hold up in court, then yes — 503B facilities would have to stop producing compounded semaglutide. 503A pharmacies might still be able to compound it with a patient-specific prescription if they can argue a clinical difference (different concentration, combined with B12, etc.).

But realistically? The shortage isn't ending anytime soon. Novo Nordisk can't meet demand. Their own projections show supply constraints through at least mid-2026.

Don't panic yet.

Last edited: Sep 6, 2025 at 1:58 AM
46 18ben_calgary, patPC_UT, Dr.DermMIA and 43 others
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hyun_seoul
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Jul 2024
Seoul, KR
Sep 6, 2025 at 12:15 AM#5

Honestly, I think the FDA should shut ALL compounding pharmacies making GLP-1s. These are complex peptides that require sophisticated manufacturing. Your local compounding pharmacy making semaglutide in a back room is not the same as Novo Nordisk's billion-dollar manufacturing facility.

Patient safety should come first. Full stop.

22 11LipidDoc_ATL, BariatricNurseD, MASHdoc_SA and 19 others
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