[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 assigned by default rule. Asking which is a fair question and the answer is usually available.
The shortage list is the legal hinge: the permissions that allow certain compounding to happen at scale are tied to a drug’s shortage status, which changes.
Screenshot none of this. Read the whole thread, including the parts where I am told I am wrong.
best — the order this archive was captured in
Nothing in this thread is medical advice, and the choice between arrangements is one for you and a prescriber who knows your history.
Potency and sterility testing on the finished preparation are separate from any certificate covering the starting material. Ask which you are being shown.
the shortage list is the whole legal hinge and people skip it
Paid noticeably more at one clinic than another for what turned out to be the same facility behind both.
Added a jurisdiction tag — the answers to this question are completely different in different countries.
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.
- 1What is the beyond-use date and what is it based on?14 comments in this branch · started by u/ruben_cabrera