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ForumsCompounding & FormulationHas anyone dealt with fda warning letters to compounding pharmacies? Page 6

Has anyone dealt with fda warning letters to compounding pharmacies?

DebRD_ATL Thu, Oct 31, 2024 at 2:36 AM 50 replies 2,916 viewsPage 6 of 10
mark_tokyo
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Jun 2024
Tokyo, JP
Nov 5, 2024 at 7:30 AM#26

Following on from james_edin — and this may be the naive question:

What would you measure differently if you were starting again?

22 22pete_manc_UK, anna.melb_AU, mark_tokyo and 19 others
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DataDave
Senior Member
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8,901
Apr 2024
Washington
Online
Nov 5, 2024 at 2:13 PM#27
PharmacoVig_BOS said:
Vendor communication red flags for compounded supply: Won't provide COA before purchase — walk away Claims "100% pure" without analytical data —…

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.

21 21mike_nyc, VendorMark, COA_Karl and 18 others
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Dr.EndoIndy
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Oct 2024
Indianapolis, IN
Nov 5, 2024 at 8:56 PM#28
PharmacoVig_BOS said:
Vendor communication red flags for compounded supply: Won't provide COA before purchase — walk away Claims "100% pure" without analytical data —…

Compounding pharmacy customer here with experience relevant to compounded supply.

I've ordered from 2 different compounding pharmacies over the past 2 years. 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 10 orders. I pay $125/month vs $1,395 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.

20 20marcus_mpls, DeniseRN_TPA, SandraNC_45 and 17 others
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BrianDallas92
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1,456
Oct 2024
Dallas, TX
Nov 6, 2024 at 3:39 AM#29
PharmacoVig_BOS said:
Vendor communication red flags for compounded supply: Won't provide COA before purchase — walk away Claims "100% pure" without analytical data —…

Genuinely useful, thank you. I had the facts and not the framework.

Last edited: Nov 6, 2024 at 4:39 AM
19 19Dr.EndoEP, GraceAZ_72, carl_compliance and 16 others
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DebRD_ATL
Senior Member
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Feb 2024
Atlanta, GA
Nov 6, 2024 at 10:22 AM#30
Dr.EndoIndy said:
Compounding pharmacy customer here with experience relevant to compounded supply.

I have been on both brand and compounded, and in the context of compounded supply, my experience has been equivalent with both. The key is finding a reliable 503B pharmacy with independent testing.

47 22HealthEcon_DC, PedsEndoPhilly, SleepDoc_PDX and 44 others
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