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ForumsCompounding & FormulationFDA warning letters to compounding pharmacies — November 2025 Page 6

FDA warning letters to compounding pharmacies — November 2025

gary_naperville Sun, Mar 15, 2026 at 7:46 PM 36 replies 1,552 viewsPage 6 of 8
SkepticalSean
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Jan 2025
Maine
Mar 25, 2026 at 6:30 PM#26

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

How long did you give it before you decided it was working?

Last edited: Mar 25, 2026 at 10:30 PM
11 11DerekSJ_a1c, paige_pharma, emma_london and 8 others
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claudia_zurich
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Jul 2024
Zurich, CH
Mar 26, 2026 at 9:36 AM#27
HPLC_Greg said:
Compounding pharmacy licensing verification for compounded supply: before ordering, verify your pharmacy's credentials: State Board of Pharmacy…

GMP compliance checklist relevant to compounded supply compounding quality:

  • Clean room environment with HEPA filtration
  • Environmental monitoring (viable and non-viable)
  • Personnel training and competency assessment
  • Validated analytical methods for testing
  • Stability testing program
  • Complete batch records and traceability
  • Quality management system with deviation handling

A 503B pharmacy following cGMP should be able to answer questions about ALL of these if you ask. Don't be afraid to ask — it's your health.

10 10tammy_FL, Dr.LipidDallas, alex_tucson and 7 others
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amsterdam_pete
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Feb 2024
Netherlands
Mar 27, 2026 at 12:42 AM#28
HPLC_Greg said:
Compounding pharmacy licensing verification for compounded supply: before ordering, verify your pharmacy's credentials: State Board of Pharmacy…

Compounding pharmacy red flag checklist for compounded supply — if ANY of these apply, find a different source:

  1. No verifiable physical address
  2. No pharmacist available for consultation
  3. COA not available or clearly template/fake
  4. Prices dramatically below market ($30-40/month = suspicious)
  5. No prescription required
  6. Ships without cold pack or temperature control
  7. No batch/lot numbers on product labeling
  8. Pushes "research use only" products for human injection

Your health depends on product quality. Don't cut corners on source verification.

Last edited: Mar 27, 2026 at 6:42 AM
9 9CanadaChris, ZaraB_AL, JakeSmashed95 and 6 others
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marcus_mpls
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Nov 2024
Minneapolis, MN
Mar 27, 2026 at 3:49 PM#29
HPLC_Greg said:
Compounding pharmacy licensing verification for compounded supply: before ordering, verify your pharmacy's credentials: State Board of Pharmacy…

That reframing is the part I needed. I will report back once I have actually tried it.

8 8Dr.PathRoch, mona_PHX, andrew_nyc and 5 others
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gary_naperville
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Oct 2024
Naperville, IL
Mar 28, 2026 at 6:56 AM#30
amsterdam_pete said:
Compounding pharmacy red flag checklist for compounded supply — if ANY of these apply, find a different source: No verifiable physical address No…

503A vs 503B compounding pharmacies for compounded supply — this distinction matters enormously:

Feature503A503B
RegulationState Board of PharmacyFDA-registered
PrescriptionRequired (patient-specific)Can compound without patient Rx
TestingVaries by statecGMP required
ScaleSmall batchesLarger production
Quality consistencyVariableGenerally higher

I strongly recommend 503B facilities. The FDA oversight and cGMP requirements mean more consistent product quality.

36 11RickReta_CO, PharmHunterJen, TomTeleRx and 33 others
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