BenResearch_OR said:They are two different exemptions from the same federal requirements and they buy different things.
Pushing back on BenResearch_OR here. A research-chemical supplier selling lyophilised powder labelled research use only is not compounding and is not claiming to. It is a different legal universe with no pharmacy oversight, no patient relationship and no content guarantee, and conflating the two in these threads helps nobody.
maria_elpaso said:My pharmacy stopped supplying with three weeks notice and a letter that explained nothing, so I went and read the statute.
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.
BariatricNurseD said:A research-chemical supplier selling lyophilised powder labelled research use only is not compounding and is not claiming to.
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.
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Shop Reference StandardsA narrower follow-up, since the general answer is now clear:
What actually distinguishes 503A from 503B, in terms of what each may make and from what starting material?
OP back with an update, since a thread like this is useless without one.
The bulks-list asymmetry was the piece I had missed entirely. It explains why one of my two pharmacies is still arguing it can supply and the other simply stopped.