lucas_SP_BR said:GMP compliance checklist relevant to compounded supply compounding quality: Clean room environment with HEPA filtration Environmental monitoring…
Genuinely useful, thank you. I had the facts and not the framework. Adding it to my notes with a link back to this thread.
From the other side of the consultation, briefly.
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.
PharmacoVig_BOS said:Beyond-use dating (BUD) for compounded supply compounded products: Lyophilized (unreconstituted): typically 12 months from compounding date…
This is my experience too, for whatever a second data point is worth.
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Browse GL BiochemPharmacoVig_BOS said:Beyond-use dating (BUD) for compounded supply compounded products: Lyophilized (unreconstituted): typically 12 months from compounding date…
Regarding compounded supply compounding legality: compounding pharmacies can legally produce semaglutide and tirzepatide while these drugs remain on the FDA shortage list. If/when the shortage resolves, the legal landscape may change.
Stay informed. The FDA shortage list is updated regularly. Current status as of my last check: semaglutide shortage ongoing, tirzepatide partially resolved. This directly impacts compounding availability.
Reporting back.
Update: the thing I was blaming turned out not to be the cause. Leaving the original post as written rather than editing it, so the mistake stays visible for whoever searches this next.