DoseLogDan said:They are two different exemptions from the same federal requirements and they buy different things.
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.
A narrower follow-up, since the general answer is now clear:
Why a shortage listing created a legal pathway at all, since a shortage is a supply fact rather than a permission?
jason_paloalto said:Beyond-use dating (BUD) for compounded supply compounded products: Lyophilized (unreconstituted): typically 12 months from compounding date…
Compounding pharmacy customer here with experience relevant to compounded supply.
I've ordered from 2 different compounding pharmacies over the past 2 years. 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 10 orders. I pay $153/month vs $1,203 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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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.
SleepDoc_PDX said:Compounding pharmacy customer here with experience relevant to compounded supply.
Agreed, and the enforcement dates were staggered by category — 503A first, 503B a few weeks later — because outsourcing facilities have manufactured inventory and clinic contracts to unwind while a 503A makes to order.