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ForumsCompounding & FormulationFDA warning letters to compounding pharmacies — November 2025 Page 4

FDA warning letters to compounding pharmacies — November 2025

gary_naperville Sun, Mar 15, 2026 at 7:46 PM 36 replies 1,552 viewsPage 4 of 8
GenomicsKate
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Mar 21, 2026 at 4:33 PM#16

Adding the clinical framing, because it changes how the question reads.

Regarding compounded supply compounding legality: compounding pharmacies can legally produce semaglutide and tirzepatide while these drugs remain on the FDA shortage list. If/when the shortage resolves, the legal landscape may change.

Stay informed. The FDA shortage list is updated regularly. Current status as of my last check: semaglutide shortage ongoing, tirzepatide partially resolved. This directly impacts compounding availability.

Last edited: Mar 21, 2026 at 9:33 PM
42 17DebRD_ATL, KristenIndy, MarkLI_maint and 39 others
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SallyK_inj
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Mar 21, 2026 at 9:03 PM#17
NicoleRaleigh said:
Compounding pharmacy response time test for compounded supply: I email customer service at odd hours to test responsiveness.

Vendor communication red flags for compounded supply:

  • Won't provide COA before purchase — walk away
  • Claims "100% pure" without analytical data — unrealistic
  • No physical address or phone number — accountability matters
  • Pushes you to buy more than you need — pressure tactics
  • Won't answer questions about their compounding process — transparency is key
  • Payment only via crypto or wire transfer — legitimate pharmacies accept cards

A legitimate compounding pharmacy operates like a healthcare business, not a gray market dealer.

41 16bbq_ray_KC, oliver_london, tane_welly and 38 others
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Dr.NateNeph
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Mar 22, 2026 at 1:33 AM#18
NicoleRaleigh said:
Compounding pharmacy response time test for compounded supply: I email customer service at odd hours to test responsiveness.

FDA inspection results for compounding pharmacies selling compounded supply: you can look up any 503B facility's FDA inspection history on the FDA website.

Check for: Form 483 observations (violations), warning letters, and recall history. A clean inspection record is a strong indicator of quality. My pharmacy has had 1 Form 483 observations in their last 2 inspections.

This is public information. Use it. Link: fda.gov/inspections-compliance-enforcement-and-criminal-investigations

Last edited: Mar 22, 2026 at 3:33 AM
40 15SteveThurs, B12Beth, RickReta_CO and 37 others
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Dr.NephBHM_UK
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Mar 22, 2026 at 6:03 AM#19

A narrower follow-up, since the general answer is now clear:

How would you tell the difference between that and the alternative explanation?

Last edited: Mar 22, 2026 at 12:03 PM
39 14SurmountFan_IN, PeptideChemSF, A1cHero_PHX and 36 others
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Admin
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Mar 22, 2026 at 10:33 AM#20

Moderator note: good thread. Keeping it here rather than moving it, because the question is general enough to be useful.

Last edited: Mar 22, 2026 at 2:33 PM
17 17PeptideSynthNJ, Dr.KarenChen, Dr.NateNeph and 14 others
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