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ForumsCompounding & FormulationBeyond-use dating for compounded peptides — my results so far Page 3

Beyond-use dating for compounded peptides — my results so far

Dr.BariatricHTX Sun, Nov 24, 2024 at 12:22 AM 12 replies 1,727 viewsPage 3 of 3
Dr.PainCLE
Senior Member
1,234
6,234
Mar 2024
Cleveland, OH
Nov 26, 2024 at 4:05 PM#11
PeptideChemSF said:
GMP compliance checklist relevant to compounded supply compounding quality: Clean room environment with HEPA filtration Environmental monitoring…

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 4 inspections.

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

46 21Dr.PathRoch, mona_PHX, andrew_nyc and 43 others
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DoseLogDan
Member
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567
Feb 2025
Montana
Nov 26, 2024 at 6:17 PM#12
Dr.RenalNash said:
Agreed, and the enforcement dates were staggered by category — 503A first, 503B a few weeks later — because outsourcing facilities have manufactured…

Saving this. It is the first explanation that did not require me to already understand it.

45 20Dr.AddMedPHL, newstart_MO, mia_MS2 and 42 others
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roxy_nash
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Dec 2024
Nashville, TN
Nov 26, 2024 at 8:29 PM#13
PeptideChemSF 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 6 months from compounding date
Reconstituted with BAC water: typically 28-30 days refrigerated
Reconstituted with sterile water: typically 24 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.

44 19tony_orlando, Dr.NephBHM_UK, kim_atl_prep and 41 others
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quinn_sf
Member
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2,123
Jun 2024
San Francisco, CA
Nov 26, 2024 at 10:41 PM#14
Dr.BariatricHTX said:
Two pharmacies quoted me last year, one describing itself as 503A and one as 503B, and I assumed 503B just meant bigger until both stopped within…

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.

43 18andrew_nyc, Dr.EndoEP, GraceAZ_72 and 40 others
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Admin
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Oct 2023
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Nov 27, 2024 at 12:53 AM#15

Moderator note: a couple of off-topic posts removed. Report rather than reply if it drifts again.

42 17PeptideSynthNJ, Dr.KarenChen, Dr.NateNeph and 39 others
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