posting this because the altrx/strive vs casa thread reminded me that most patients are evaluating compounded vials on vibes and a screenshot of a coa. here’s the actual checklist i run, in the order i run it. not legal advice, not dosing advice, just what i look at. 1. is the dispensing pharmacy 503a or 503b. these are different regulatory animals. 503a = patient-specific rx, no commercial-scale manufacturing, no batch testing requirement the way 503b has. 503b is registered as an outsourcing facility w/ fda and is held to cgmp. neither is automatically safer, but the failure modes differ. 2. base vs salt. semaglutide sodium and tirzepatide sodium are not the same molecule as the base. if the label or coa says “sodium” on a sterile injectable for a human, i stop reading. that’s been the fda’s position and it’s also just chemistry. 3. beyond-use date. ask. a 90-day bud on a multi-dose vial without preservative and without supporting stability data is not the same as a 90-day bud with it. the bud is only as good as the data behind it. 4. sterility and endotoxin testing on the lot. for any sterile compounded preparation. usp 797 is the floor. 5. coa from the api supplier, plus a finished-product coa if available. the api coa alone tells you nothing about what’s in the vial after compounding. if a pharmacy can’t or won’t answer those five, that tells you what you need to know. doesn’t mean they’re bad actors. does mean you don’t have enough info to consent.
The base vs. salt point is the one I wish more patients understood before they even get to the CoA conversation, because “tirzepatide sodium” from an API supplier gets absorbed into patient communities as a minor label quirk rather than the actual chemistry problem it’s. Where I’d gently push back is on point five, specifically the finished-product CoA.
Even when pharmacies provide one, the gap between the CoA date and the dispensing date can be quite significant, and stability data for tirzepatide in multi-dose compounded format isn’t exactly a settled body of literature yet. The API CoA tells you what came in, the finished-product CoA tells you what was tested at some point, but neither tells you what’s in the vial you’re drawing from six weeks into a 90-day supply. I’ve been on compounded tirz for several months, I log lot dates and draw dates, and the stability piece is honestly the one part of this where I feel least able to evaluate what I’m told even after doing quite a bit of reading. The five questions are the right five questions. I just think the answers to number five deserve a bit more scrutiny than the document itself might suggest.
you’re right that the gap between test date and draw date matters, and i should have been clearer about that in the original. where i’d push back: a finished-product coa with a real stability-indicating assay (not just potency at t=0) is meaningfully different from a coa that just confirms what came out of the hood that day. the literature on multi-dose tirz stability is thin, agreed, but some 503b-registered facilities have submitted forced-degradation data to support their bud. ask whether the bud is supported by stability data or just by usp 797 default categories. that’s the real question hiding inside #5.
usp 797 default categories are worst-case floors for compounding conditions, not stability claims, so “bud supported by usp 797 defaults” and “bud supported by stability data” aren’t two points on a spectrum, they’re categorically different types of assertions and the pharmacy that conflates them probably doesn’t know which one they’re making.