LabKate said:Resolution therefore closed the doors unevenly, and the asymmetry follows from the bulks lists.
I read this differently from LabKate, 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.
Dr.AddMedPHL 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 9 months from compounding date
Reconstituted with BAC water: typically 28-30 days refrigerated
Reconstituted with sterile water: typically 7 days (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.
COA_Karl said:A research-chemical supplier selling lyophilised powder labelled research use only is not compounding and is not claiming to.
Coming at COA_Karl’s question from a different direction. Denials are usually procedural rather than clinical, and the order that works reflects that. Get the denial reason in writing, because it names the criterion you failed. Then supply the documentation that criterion asks for — usually documented BMI with a comorbidity, or a failed prior therapy. Then appeal, and ask for a peer-to-peer review, because a prescriber talking to a reviewing clinician resolves a large fraction of denials that written appeals do not. Manufacturer copay assistance is separate and applies mainly to commercial insurance, and patient assistance programmes are means-tested rather than a discount.
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View ResultsOne thing that is still open after Dr.PathRoch’s answer:
Why a shortage listing created a legal pathway at all, since a shortage is a supply fact rather than a permission?
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.