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ForumsCompounding & FormulationIs it normal for the powder to not fully dissolve — July 2024 Page 4

Is it normal for the powder to not fully dissolve — July 2024

PedsEndoPhilly Wed, Feb 7, 2024 at 3:59 PM 60 replies 3,510 viewsPage 4 of 12
Dr.SleepRoch
Senior Member
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Apr 2024
Rochester, MN
Feb 12, 2024 at 10:28 PM#16

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

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 0 Form 483 observations in their last 3 inspections.

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

4 2sarah_TO, wendy_avl, jason_paloalto and 1 other
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julia.endo
Senior Member
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Feb 2024
Cincinnati, OH
Feb 13, 2024 at 8:11 AM#17
PeptideSynthNJ said:
GMP compliance checklist relevant to compounded supply compounding quality: Clean room environment with HEPA filtration Environmental monitoring…

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

Lyophilized (unreconstituted): typically 9 months from compounding date
Reconstituted with BAC water: typically 28-30 days refrigerated
Reconstituted with sterile water: typically 7 days (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.

5 3mark_tokyo, hans_munich, jason_sac26 and 2 others
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VanRx_Mike
Member
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May 2024
Vancouver, CA
Feb 13, 2024 at 5:54 PM#18
PeptideSynthNJ said:
GMP compliance checklist relevant to compounded supply compounding quality: Clean room environment with HEPA filtration Environmental monitoring…

Bookmarking. The distinction being drawn above is the one nobody else makes. Taking it to my next appointment.

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Dr.PainCLE
Senior Member
1,234
6,234
Mar 2024
Cleveland, OH
Feb 14, 2024 at 3:37 AM#19

Clinical perspective, offered as context rather than as advice.

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.

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mike_mod
Moderator
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Nov 2023
New York
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Feb 14, 2024 at 1:20 PM#20

Moderator note: a post naming a supplier has been edited. Discuss suppliers in the review sections, not here. Report rather than reply if it drifts again.

29 2PurityPaulOR, MaxMetOK, MounjBrad and 26 others
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