TrialTracker_MD said:The shortage clause is the answer to the second question and it is a subtraction rather than an addition.
This is where I part company with the consensus forming above. 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.
PharmHunterJen said:My pharmacy stopped supplying with three weeks notice and a letter that explained nothing, so I went and read the statute.
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 shortage ongoing, tirzepatide partially resolved. This directly impacts compounding availability.
Dr.SportsMedIN said:A research-chemical supplier selling lyophilised powder labelled research use only is not compounding and is not claiming to.
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.
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Shop Reference StandardsOne thing that is still open after NicoleRaleigh’s answer:
What actually distinguishes 503A from 503B, in terms of what each may make and from what starting material?
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.