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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
JakeSmashed95
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Nov 5, 2024 at 7:30 AM#26
BethLabQueen said:
I have been on both brand and compounded, and in the context of compounded supply, my experience has been equivalent with both.

Thank you for spelling out the reasoning rather than just the conclusion.

22 22Dr.PainCLE, mike_mealprep, NicoleRaleigh and 19 others
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PharmD_Rodriguez
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Nov 5, 2024 at 2:13 PM#27

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

For compounded supply users considering compounded for the first time: here's a step-by-step guide:

  1. Get a prescription from your doctor (telehealth counts)
  2. Research 503B compounding pharmacies with good community reviews
  3. Verify their FDA registration and inspection history
  4. Request a COA for your specific compound before ordering
  5. Start with a 1-month supply to test
  6. Consider sending a sample to Janoshik for independent verification
  7. Track your response compared to brand (if you were on it previously)
21 21TinaHashiRN, robert_kc, dan_philly and 18 others
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amy_econ_NJ
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Nov 5, 2024 at 8:56 PM#28
PharmD_Rodriguez said:
For compounded supply users considering compounded for the first time: here's a step-by-step guide: Get a prescription from your doctor (telehealth…

This is my experience too, for whatever a second data point is worth. I had assumed I was the exception until I read this.

20 20sean_dublin, hannah_MT, Dr.SportsMedIN and 17 others
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TinaHashiRN
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Nov 6, 2024 at 3:39 AM#29
PharmD_Rodriguez said:
For compounded supply users considering compounded for the first time: here's a step-by-step guide: Get a prescription from your doctor (telehealth…

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 same day. They answered my questions about sterility testing thoroughly and professionally.

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

19 19Admin, Dr.Martinez, mike_mod and 16 others
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DebRD_ATL
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Nov 6, 2024 at 10:22 AM#30

OP back with an update, since a thread like this is useless without one.

Coming back a few months on. It held. Nothing dramatic to report, which is the report.

47 22HealthEcon_DC, PedsEndoPhilly, SleepDoc_PDX and 44 others
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