[Question] Ireland — has anyone got a straight answer on shortage list
The title is the whole question — Ireland — has anyone got a straight answer on shortage list — but here is why I am asking.
Paid noticeably more at one clinic than another for what turned out to be the same facility behind both.
Switched between two compounded preparations and the concentration on the label was different. Redid the arithmetic on paper before drawing anything.
Asked for the beyond-use date basis and got a real answer with a stability reference attached. Not universal, apparently.
If somebody has the same thing measured a different way, post it next to mine and we will see whether they agree.
best — the order this archive was captured in
A 503A pharmacy compounds for an identified patient against a prescription. A 503B outsourcing facility registers with the regulator, may produce without patient-specific prescriptions, and is subject to current good manufacturing practice requirements. The two are governed differently and the difference is not cosmetic.
the pharmacy and the prescriber are two separate questions
Was there potency testing on the finished preparation, or only on the starting material?
the label on a compounded vial is a legal document, read it
Asked which facility and got a name straight away. Looked it up, found the registration, felt considerably better about the whole thing.
Kept the label from every vial. When the shortage status changed, having the paper trail made the conversation much shorter.
Kept the label from every vial.
Disagreeing with this bit: registration is not equivalence, and the two get run together constantly.
I would not read the price difference as a quality signal. Most of it is the consultation model, not the vial.
Careful. Naming a clinic without describing what actually happened turns this into a different kind of thread.
Disagree — a 503B being registered does not make its preparations equivalent to an approved product. Different regulatory category entirely.
Asked for potency testing on the finished preparation. They had it. I had assumed they would not.
What concentration is on the label, and does it match what you were expecting?
What is the beyond-use date and what is it based on?
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That figure is the starting material purity, not the finished preparation potency. Two different tests.
That is not what patient-specific means. It refers to the prescription, not to a customisation of the formula.
the price difference is mostly the intake, not the vial
Push back: "compounded is fine because a pharmacy made it" skips every question this board exists to ask.
503A is patient-specific, 503B is outsourcing facility, they are not the same thing
Potency and sterility testing on the finished preparation are separate from any certificate covering the starting material. Ask which you are being shown.
do not assume the concentration matches the branded product
Yes — asking which facility, by name, is the single most useful question and most clinics will answer it.
- 1Disagree — a 503B being registered does not make its preparations equivalent…7 comments in this branch · started by u/yannick_petrov