EU EMA compounding guidance — need advice

Dr.RenalNash said:

Resolution therefore closed the doors unevenly, and the asymmetry follows from the bulks lists.

This is where I part company with the consensus forming above. 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.

VanRx_Mike said:

My pharmacy stopped supplying with three weeks notice and a letter that explained nothing, so I went and read the statute.

503A vs 503B compounding pharmacies for compounded supply — this distinction matters enormously:

I strongly recommend 503B facilities. The FDA oversight and cGMP requirements mean more consistent product quality.

SarahChen_PharmD said:

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

Compounded has been just as effective for me. If compounded supply is the concern, the COA from my 503B pharmacy shows 99.1% purity. Verified by Janoshik.

One thing that is still open after mia_MS2’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.