gary_naperville said:

Update: approved on the third attempt after a peer-to-peer.

This is my experience too, for whatever a second data point is worth. I had assumed I was the exception until I read this.

gary_naperville said:

Update: approved on the third attempt after a peer-to-peer.

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.

gary_naperville said:

Update: approved on the third attempt after a peer-to-peer.

Beyond-use dating (BUD) for compounded supply compounded products:

Lyophilized (unreconstituted): typically 6 months from compounding date
Reconstituted with BAC water: typically 28-30 days refrigerated
Reconstituted with sterile water: typically 24 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.

Following on from gary_naperville — and this may be the naive question:

Did your prescriber agree with that reading, and if not what was their objection?

wendy_avl said:

Beyond-use dating (BUD) for compounded supply compounded products: Lyophilized (unreconstituted): typically 6 months from compounding date…

I have been on both brand and compounded, and in the context of compounded supply, my experience has been equivalent with both. The key is finding a reliable 503B pharmacy with independent testing.