[Meta] the 503B rule is doing its job and people should stop complaining
the 503B rule is doing its job and people should stop complaining, and here is what changes in practice if it goes ahead. Asked for potency testing on the finished preparation. They had it. I had assumed they would not. A beyond-use date derived from published stability data means something different from one…
What is the beyond-use date and what is it based on?
Is the compound still on the shortage list where you are?
That figure is the starting material purity, not the finished preparation potency. Two different tests.
salt forms are the recurring argument and the answer is boring
do not assume the concentration matches the branded product
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.
if a clinic will not name the facility, that is your answer
Cosigning the beyond-use date question. What it is based on tells you whether anybody has done stability work.
potency testing on the finished preparation is the thing to ask for
Concentration on the compounded vial was different from what I had been using and I nearly did the arithmetic on autopilot.
the pharmacy and the prescriber are two separate questions
Concentration on the compounded vial was different from what I had been using and I nearly did the arithmetic on autopilot.
Disagreeing with this bit: registration is not equivalence, and the two get run together constantly.
Asked for the beyond-use date basis and got a real answer with a stability reference attached. Not universal, apparently.