MikeFit_NJ said:They are two different exemptions from the same federal requirements and they buy different things.
I read this differently from MikeFit_NJ, 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.
lucas_SP_BR 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.
julia.endo said:A research-chemical supplier selling lyophilised powder labelled research use only is not compounding and is not claiming to.
Compounding pharmacy red flag checklist for compounded supply — if ANY of these apply, find a different source:
- No verifiable physical address
- No pharmacist available for consultation
- COA not available or clearly template/fake
- Prices dramatically below market ($30-40/month = suspicious)
- No prescription required
- Ships without cold pack or temperature control
- No batch/lot numbers on product labeling
- Pushes "research use only" products for human injection
Your health depends on product quality. Don't cut corners on source verification.
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Shop Reference StandardsFollowing on from emma_london — and this may be the naive question:
Why a shortage listing created a legal pathway at all, since a shortage is a supply fact rather than a permission?
Reporting back.
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.