Dr.ReproEndo said:The shortage clause is the answer to the second question and it is a subtraction rather than an addition.
This is exactly what I could not find anywhere else. Printing the relevant bit and taking it with me.
Clinical perspective, offered as context rather than as advice.
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.
hans_munich said:Denials are usually procedural rather than clinical, and the order that works reflects that.
Filing a mild objection. Mild because I might be wrong; an objection because nobody has addressed the case that does not fit. The affordability discussion here usually stops at individual tactics. At list price this class is out of reach for most of the people who would benefit, and no amount of appeal strategy changes that — it is a pricing problem wearing a paperwork costume.
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Shop Reference StandardsDr.RheumBOS said:They are two different exemptions from the same federal requirements and they buy different things.
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.