Dr.ObesityMed said:

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

Regarding compounded supply compounding legality: compounding pharmacies can legally produce semaglutide and tirzepatide while these drugs remain on the FDA shortage list. If/when the shortage resolves, the legal landscape may change.

Stay informed. The FDA shortage list is updated regularly. Current status as of my last check: semaglutide still in shortage, tirzepatide removed from shortage list. This directly impacts compounding availability.

Dr.BariatricHTX 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…

This is exactly what I could not find anywhere else. Sending this to two other people who asked me the same thing last week.

Dr.ObesityMed said:

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

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

Lyophilized (unreconstituted): typically 12 months from compounding date
Reconstituted with BAC water: typically 28-30 days refrigerated
Reconstituted with sterile water: typically 48 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.

VanRx_Mike said:

Two pharmacies quoted me last year, one describing itself as 503A and one as 503B, and I assumed 503B just meant bigger until both stopped within…

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.

Moderator note: good thread. Keeping it here rather than moving it, because the question is general enough to be useful.