the Netherlands: state board, and what it actually costs here
the Netherlands: state board, and what it actually costs here — a position I have arrived at slowly and would like tested. Salt form matters for mass: a preparation specified as one salt and dosed as the free base gives you a different amount of peptide for the same number on the label. Asked which facility and got a…
The intake asked me three questions and none of them were about my history. That told me everything I needed to know about the model.
Push back: "compounded is fine because a pharmacy made it" skips every question this board exists to ask.
a 503B has to register and report, so there is a paper trail to ask for
This. Compounded preparations carry no equivalence claim, and treating them as generics is a category error people make constantly.
This.
Disagreeing with this bit: registration is not equivalence, and the two get run together constantly.
That figure is the starting material purity, not the finished preparation potency. Two different tests.
the shortage list is the whole legal hinge and people skip it
Kept the label from every vial. When the shortage status changed, having the paper trail made the conversation much shorter.