labquiet_amy said:They are two different exemptions from the same federal requirements and they buy different things.
Filing a mild objection. Mild because I might be wrong; an objection because nobody has addressed the case that does not fit. A research-chemical supplier selling lyophilised powder labelled research use only is not compounding and is not claiming to. It is a different legal universe with no pharmacy oversight, no patient relationship and no content guarantee, and conflating the two in these threads helps nobody.
Correct me if the detail matters more than I have assumed.
denise_HTX said:My pharmacy stopped supplying with three weeks notice and a letter that explained nothing, so I went and read the statute.
Compounding pharmacy red flag checklist for compounded supply — if ANY of these apply, find a different source:
- No verifiable physical address
- No pharmacist available for consultation
- COA not available or clearly template/fake
- Prices dramatically below market ($30-40/month = suspicious)
- No prescription required
- Ships without cold pack or temperature control
- No batch/lot numbers on product labeling
- Pushes "research use only" products for human injection
Your health depends on product quality. Don't cut corners on source verification.
Dr.SurgeonPGH said:A research-chemical supplier selling lyophilised powder labelled research use only is not compounding and is not claiming to.
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.
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Shop Reference StandardsOne thing that is still open after VendorMark’s answer:
Why a shortage listing created a legal pathway at all, since a shortage is a supply fact rather than a permission?
Reporting back.
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.