BariatricNurseD said:The shortage clause is the answer to the second question and it is a subtraction rather than an addition.
Bookmarking. The distinction being drawn above is the one nobody else makes.
From the other side of the consultation, briefly.
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.
SarahChen_PharmD said:The mechanism that matters here is not stomach emptying, it is central.
I will push back on the "any working dose is fine" framing. The maintenance evidence sits overwhelmingly at the top studied dose, and the extension data shows regain tracking dose reduction rather than tracking stopping. Holding low is reasonable; pretending it is evidentially equivalent is not.
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Browse GL BiochemPeptideSynthNJ said:They are two different exemptions from the same federal requirements and they buy different things.
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 partially resolved shortage, tirzepatide still in shortage. This directly impacts compounding availability.