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ForumsCompounding & FormulationMy vial looks cloudy - throw it out?? — looking for input Page 6

My vial looks cloudy - throw it out?? — looking for input

SleepFixSam Thu, Mar 21, 2024 at 7:19 PM 30 replies 2,350 viewsPage 6 of 6
BethLabQueen
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Apr 3, 2024 at 6:38 AM#26
Dr.EndoIndy 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 2 hours. They answered my questions about storage conditions thoroughly and professionally.

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

25 23maya_sedona, stefan_berlin, Dr.EM_Chicago and 22 others
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PeptideChemSF
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Apr 4, 2024 at 6:21 PM#27
Dr.EndoIndy 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…

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.

Last edited: Apr 4, 2024 at 10:21 PM
26 24dave_SLC, FDA_TrackerJim, ricardo_MIA and 23 others
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BiostatsBrad
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Apr 6, 2024 at 6:04 AM#28

Following on from Dr.EndoIndy — and this may be the naive question:

How would you tell the difference between that and the alternative explanation?

Last edited: Apr 6, 2024 at 7:04 AM
27 0FranDenver, Dr.BariatricHTX, LindaRN_retired and 24 others
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JakeBK_lifts
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Apr 7, 2024 at 5:48 PM#29
PeptideChemSF said:
GMP compliance checklist relevant to compounded supply compounding quality: Clean room environment with HEPA filtration Environmental monitoring…

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.

28 1kate.chem, DataDave, Dr.GutHealth and 25 others
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SleepFixSam
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Apr 9, 2024 at 5:33 AM#30
PeptideChemSF said:
GMP compliance checklist relevant to compounded supply compounding quality: Clean room environment with HEPA filtration Environmental monitoring…

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.

Last edited: Apr 9, 2024 at 7:33 AM
50 23fiona_VT, denise_HTX, raj_cambridge and 47 others
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