First time ordering compounded - what do I even look for?? — 6 month update

mike_nyc said:

The shortage clause is the answer to the second question and it is a subtraction rather than an addition.

Filing a mild objection. Mild because I might be wrong; an objection because nobody has addressed the case that does not fit. 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.

mel_PDX 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 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.

kate.chem said:

A research-chemical supplier selling lyophilised powder labelled research use only is not compounding and is not claiming to.

For compounded supply users considering compounded for the first time: here's a step-by-step guide:

1. Get a prescription from your doctor (telehealth counts)
2. Research 503B compounding pharmacies with good community reviews
3. Verify their FDA registration and inspection history
4. Request a COA for your specific compound before ordering
5. Start with a 1-month supply to test
6. Consider sending a sample to Janoshik for independent verification
7. Track your response compared to brand (if you were on it previously)

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?

Closing the loop on my own question.

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.