julia.endo said:The shortage clause is the answer to the second question and it is a subtraction rather than an addition.
Pushing back on julia.endo here. 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.
mark_tokyo 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.
PharmacoVig_BOS 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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View ResultsA narrower follow-up, since the general answer is now clear:
Why a shortage listing created a legal pathway at all, since a shortage is a supply fact rather than a permission?
Closing the loop on my own question.
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.