Compounded tirz stability at room temperature — what worked for you?

FDA_TrackerJim said:

They are two different exemptions from the same federal requirements and they buy different things.

Pushing back on FDA_TrackerJim here. 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.

Correct me if the detail matters more than I have assumed.

One concrete data point for the thread. Two things anyone can check: a state licence number for a 503A, and an FDA outsourcing-facility registration for a 503B. Both are publicly searchable, and a pharmacy unwilling to give you either has answered the question.

InsuranceTom said:

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

Adding the part of the answer the thread has not reached. Resolution therefore closed the doors unevenly, and the asymmetry follows from the bulks lists. For 503B the shortage clause was the only route to these molecules, so that route shut completely. A 503A pharmacy can still argue a doorway via "component of an approved drug" — but only for the substance in the form present in the approved product, which is exactly where the base-versus-salt argument lives, and it does nothing about the copy restriction, which came back into force on resolution.

I would rather be corrected than agreed with, if it comes to it.

One thing that is still open after bri_stats’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.

Update: the excursion was survivable and the vial was fine. I now keep a cheap fridge thermometer, which costs nothing and ends the argument.