Endotoxin testing in compounded injectables — anyone have experience?

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:

1. No verifiable physical address
2. No pharmacist available for consultation
3. COA not available or clearly template/fake
4. Prices dramatically below market ($30-40/month = suspicious)
5. No prescription required
6. Ships without cold pack or temperature control
7. No batch/lot numbers on product labeling
8. Pushes "research use only" products for human injection

Your health depends on product quality. Don't cut corners on source verification.

Following 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.