DeniseRN_TPA said:

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

GMP compliance checklist relevant to compounded supply compounding quality:

• Clean room environment with HEPA filtration
• Environmental monitoring (viable and non-viable)
• Personnel training and competency assessment
• Validated analytical methods for testing
• Stability testing program
• Complete batch records and traceability
• Quality management system with deviation handling

A 503B pharmacy following cGMP should be able to answer questions about ALL of these if you ask. Don't be afraid to ask — it's your health.

One thing that is still open after Dr.ObesityMed’s answer:

Why a shortage listing created a legal pathway at all, since a shortage is a supply fact rather than a permission?

VendorMark said:

GMP compliance checklist relevant to compounded supply compounding quality: Clean room environment with HEPA filtration Environmental monitoring…

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.

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.

TinaHashiRN said:

503A vs 503B compounding pharmacies for compounded supply — this distinction matters enormously: Feature 503A 503B Regulation State Board of Pharmacy…

No disagreement with TinaHashiRN. One condition attached. Worth adding the genuine exception, because it is real and narrow: a change made for an identified patient where the prescriber determines it produces a significant clinical difference for that patient. A grid of fixed doses offered to everybody is not that, whatever the intake form says.