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ForumsBuyer BewareHas anyone dealt with ⚠ amino asylum raided by fda june 2025?

Has anyone dealt with ⚠ amino asylum raided by fda june 2025?

tommy_boulder Mon, Mar 4, 2024 at 11:30 AM 41 replies 2,226 viewsPage 1 of 9
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tommy_boulder
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Nov 2024
Boulder, CO
Mar 4, 2024 at 12:55 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.

12 13paul_denver, TinaHashiRN, robert_kc and 9 others
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JenMemphis
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Jan 2025
Memphis, TN
Mar 4, 2024 at 1:12 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. ⚖️

Last edited: Mar 4, 2024 at 6:12 PM
18 20BenResearch_OR, MikeKY_noInsulin, Dr.RaviCardio and 15 others
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emma_london
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Oct 2024
London, UK
Mar 4, 2024 at 1:29 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.

35 0TomFromTexas, mike.trainer_LA, sarah_nash92 and 32 others
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kate.chem
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Mar 4, 2024 at 1:46 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.

7 1jennifer_SEA, tyler_CSCS, VanRx_Mike and 4 others
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bri_stats
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May 2024
Seattle, WA
Mar 4, 2024 at 2:03 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.

Last edited: Mar 4, 2024 at 6:03 PM
29 24julia.endo, JessicaM_2024, TomFromTexas and 26 others
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