traveltech_sara said:

The useful checklist is about verifiability rather than presentation.

Agreed, with a caveat about community reputation: it is a lagging indicator. Reports arrive weeks after orders, so a supplier can look excellent for a month after quality has already changed.

Worth separating that from vendor vetting, which this thread keeps folding into the same question. They behave differently and the advice does not transfer.

EndoResFellow said:

Worth adding the genuine exception, because it is real and narrow: a change made for an identified patient where the prescriber determines it produces…

Genuinely useful, thank you. I had the facts and not the framework. Adding it to my notes with a link back to this thread.

traveltech_sara said:

The useful checklist is about verifiability rather than presentation.

I disagree that testing history is decisive. It tells you what a supplier did when they were being watched. Continuity of behaviour under stress — a late shipment, a failed test, a complaint — is more predictive than any run of good results.

PharmHunterJen said:

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

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.

Moderator note: two posts asking for a source have been merged into one. Please search the thread before asking again.