Dr.MetabolicMD 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.
One thing that is still open after Dr.MetabolicMD’s answer:
What did you change at the same time, and can you separate the two now?
dave_SLC said:Beyond-use dating (BUD) for compounded supply compounded products: Lyophilized (unreconstituted): typically 6 months from compounding date…
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.
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Shop Reference Standardsdave_SLC said:Beyond-use dating (BUD) for compounded supply compounded products: Lyophilized (unreconstituted): typically 6 months from compounding date…
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.
dave_SLC said:Beyond-use dating (BUD) for compounded supply compounded products: Lyophilized (unreconstituted): typically 6 months from compounding date…
This answered a question I did not know how to ask.