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ForumsCompounding & FormulationFDA warning letters to compounding pharmacies — November 2025 Page 3

FDA warning letters to compounding pharmacies — November 2025

gary_naperville Sun, Mar 15, 2026 at 7:46 PM 36 replies 1,552 viewsPage 3 of 8
BethLabQueen
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Mar 20, 2026 at 6:04 PM#11
sophie_paris said:
Compounding pharmacy red flag checklist for compounded supply — if ANY of these apply, find a different source: No verifiable physical address No…

Beyond-use dating (BUD) for compounded supply compounded products:

Lyophilized (unreconstituted): typically 9 months from compounding date
Reconstituted with BAC water: typically 28-30 days refrigerated
Reconstituted with sterile water: typically 7 days (no preservative!)

Always use BAC water for multi-dose vials. Sterile water has no preservative and supports bacterial growth after first puncture. This is a common and potentially dangerous mistake.

47 22maya_sedona, stefan_berlin, Dr.EM_Chicago and 44 others
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dan_philly
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Mar 20, 2026 at 10:33 PM#12
A1cHero_PHX said:
Worth adding the genuine exception, because it is real and narrow: a change made for an identified patient where the prescriber determines it produces…

That reframing is the part I needed.

46 21AmyNC_wife, SkepticalSean, Dr.CardioMD and 43 others
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Dr.EM_Chicago
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Chicago, IL
Mar 21, 2026 at 3:03 AM#13
sophie_paris said:
Compounding pharmacy red flag checklist for compounded supply — if ANY of these apply, find a different source: No verifiable physical address No…

Compounding pharmacy licensing verification for compounded supply: before ordering, verify your pharmacy's credentials:

  1. State Board of Pharmacy license — check on your state BOP website
  2. FDA registration (for 503B) — check on fda.gov
  3. DEA registration if handling controlled substances
  4. PCAB accreditation — voluntary but demonstrates commitment to quality
  5. USP <797>/<800> compliance for sterile compounding

This takes 10 minutes of research and could save you from receiving substandard or unsafe medication.

45 20Dr.ReproEndo, lucas_SP_BR, lisa_labSD and 42 others
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NicoleRaleigh
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Mar 21, 2026 at 7:33 AM#14
gary_naperville said:
Two pharmacies quoted me last year, one describing itself as 503A and one as 503B, and I assumed 503B just meant bigger until both stopped within…

Compounding pharmacy response time test for compounded supply: I email customer service at odd hours to test responsiveness. A pharmacy that can't answer questions promptly is a red flag.

My current pharmacy: average response time 1 hour. They answered my questions about batch-specific COAs thoroughly and professionally.

Communication quality is a proxy for operational quality. A pharmacy that communicates well is likely manufacturing well too.

44 19VendorMark, COA_Karl, MikeFit_NJ and 41 others
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mike_mod
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Mar 21, 2026 at 12:03 PM#15

Moderator note: the sourcing question belongs in the vendor section and has been split out. Tagging this one for the weekly digest.

Last edited: Mar 21, 2026 at 2:03 PM
43 18PurityPaulOR, MaxMetOK, MounjBrad and 40 others
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