LarryQC_SD said:They are two different exemptions from the same federal requirements and they buy different things.
I read this differently from LarryQC_SD, on substance rather than tone. 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.
tampaLisa73 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…
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.
Dr.MetabolicMD said:A research-chemical supplier selling lyophilised powder labelled research use only is not compounding and is not claiming to.
Compounding pharmacy customer here with experience relevant to compounded supply.
I've ordered from 5 different compounding pharmacies over the past 18 months. The quality variation is real — purity ranged from 94% to 101% of label claim based on independent Janoshik testing.
My current compounder (a 503B facility) has been consistently 98-101% purity across 5 orders. I pay $164/month vs $1,394 for brand. The savings are substantial and the product is equivalent in my experience.
Re: compounded supply — this applies whether you're using brand or compounded. The clinical principles are the same.
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Shop Reference StandardsOne thing that is still open after MikeNYC_runner’s answer:
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.