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ForumsCompounding & FormulationHow do you guys store your vials when traveling — need advice Page 3

How do you guys store your vials when traveling — need advice

SkepticalSean Thu, Mar 7, 2024 at 1:12 PM 17 replies 2,120 viewsPage 3 of 4
NurseAsh_DET
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Mar 12, 2024 at 11:52 AM#11
Dr.SleepRoch said:
They are two different exemptions from the same federal requirements and they buy different things.

This is exactly what I could not find anywhere else. I will report back once I have actually tried it.

43 16FDA_TrackerJim, ricardo_MIA, BrianDallas92 and 40 others
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LindaRN_retired
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Sarasota, FL
Mar 13, 2024 at 8:07 PM#12

Clinical perspective, offered as context rather than as advice.

FDA inspection results for compounding pharmacies selling compounded supply: you can look up any 503B facility's FDA inspection history on the FDA website.

Check for: Form 483 observations (violations), warning letters, and recall history. A clean inspection record is a strong indicator of quality. My pharmacy has had 1 Form 483 observations in their last 2 inspections.

This is public information. Use it. Link: fda.gov/inspections-compliance-enforcement-and-criminal-investigations

44 17Dr.GutHealth, amsterdam_pete, LondonLisa and 41 others
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Dr.NutriCornell
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Mar 15, 2024 at 4:23 AM#13
james_edin said:
Vendor communication red flags for compounded supply: Won't provide COA before purchase — walk away Claims "100% pure" without analytical data —…

Beyond-use dating (BUD) for compounded supply compounded products:

Lyophilized (unreconstituted): typically 12 months from compounding date
Reconstituted with BAC water: typically 28-30 days refrigerated
Reconstituted with sterile water: typically 48 hours (no preservative!)

Always use BAC water for multi-dose vials. Sterile water has no preservative and supports bacterial growth after first puncture. This is a common and potentially dangerous mistake.

Last edited: Mar 15, 2024 at 6:23 AM
45 18laura_annarbor, JenMemphis, pat_auckland and 42 others
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BiostatsBrad
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Mar 16, 2024 at 12:40 PM#14
SkepticalSean said:
Resolution therefore closed the doors unevenly, and the asymmetry follows from the bulks lists.

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 1 hour. They answered my questions about batch-specific COAs thoroughly and professionally.

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

46 19james_edin, FranDenver, Dr.BariatricHTX and 43 others
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mike_mod
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Mar 17, 2024 at 8:57 PM#15

Moderator note: leaving this open. It is being argued well and the disagreement is the useful part. Thread quality here is what the rules are for. Keep it up.

47 20PurityPaulOR, MaxMetOK, MounjBrad and 44 others
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