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ForumsCompounding & FormulationFDA warning letters to compounding pharmacies — November 2025 Page 5

FDA warning letters to compounding pharmacies — November 2025

gary_naperville Sun, Mar 15, 2026 at 7:46 PM 36 replies 1,552 viewsPage 5 of 8
amsterdam_pete
Senior Member
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Feb 2024
Netherlands
Mar 22, 2026 at 3:05 PM#21
Dr.NateNeph said:
FDA inspection results for compounding pharmacies selling compounded supply: you can look up any 503B facility's FDA inspection history on the FDA…

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.

16 16JakeSmashed95, NauseaFreeNow, SteveThurs and 13 others
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jim_asheville
Member
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1,234
Aug 2024
Asheville, NC
Mar 23, 2026 at 6:09 AM#22
Dr.NateNeph said:
FDA inspection results for compounding pharmacies selling compounded supply: you can look up any 503B facility's FDA inspection history on the FDA…

Thank you for spelling out the reasoning rather than just the conclusion. Taking it to my next appointment.

15 15BenResearch_OR, MikeKY_noInsulin, Dr.RaviCardio and 12 others
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Dr.PathRoch
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Jun 2024
Rochester, MN
Mar 23, 2026 at 9:14 PM#23

From the other side of the consultation, briefly.

Compounding pharmacy customer here with experience relevant to compounded supply.

I've ordered from 3 different compounding pharmacies over the past year. The quality variation is real — purity ranged from 94% to 101% of label claim based on independent Janoshik testing.

My current compounder (a 503B facility) has been consistently 98-101% purity across 6 orders. I pay $146/month vs $1,296 for brand. The savings are substantial and the product is equivalent in my experience.

Re: compounded supply — this applies whether you're using brand or compounded. The clinical principles are the same.

14 14WendyG_ATL, SaraMom3, Dr.MetabolicMD and 11 others
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NauseaFreeNow
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345
1,234
Aug 2024
Indiana
Mar 24, 2026 at 12:19 PM#24
Dr.PathRoch said:
Compounding pharmacy customer here with experience relevant to compounded supply.

Mine went the same way, slower.

Last edited: Mar 24, 2026 at 4:19 PM
13 13lori_vegas, Dr.PulmRoch, maya_sedona and 10 others
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KristenIndy
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May 2024
Indianapolis, IN
Mar 25, 2026 at 3:24 AM#25
Dr.PathRoch said:
Compounding pharmacy customer here with experience relevant to compounded supply.

Compounded has been just as effective for me. If compounded supply is the concern, the COA from my 503B pharmacy shows 99.1% purity. Verified by Janoshik.

12 12kate.chem, DataDave, Dr.GutHealth and 9 others
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