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ForumsBuyer Beware⚠ Swiss Chems FDA warning letter December 2024 — looking for input

⚠ Swiss Chems FDA warning letter December 2024 — looking for input

adam_van Mon, Feb 19, 2024 at 8:18 PM 20 replies 2,373 viewsPage 1 of 4
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adam_van
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Feb 19, 2024 at 9:43 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.

27 20FranDenver, Dr.BariatricHTX, LindaRN_retired and 24 others
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FDA_TrackerJim
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Feb 19, 2024 at 10:00 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 6Admin, Dr.Martinez, mike_mod and 4 others
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BrianDallas92
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Feb 19, 2024 at 10:17 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.

39 5andrew_nyc, Dr.EndoEP, GraceAZ_72 and 36 others
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jason_paloalto
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Feb 19, 2024 at 10:34 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.

41 0andrew_nyc, Dr.EndoEP, GraceAZ_72 and 38 others
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Dr.ObesityMed
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Feb 19, 2024 at 10:51 PM#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.

40 8A1cHero_PHX, Dr.RenalNash, LipidDoc_ATL and 37 others
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