three years of shortage list threads, summarised so you do not have to read them
three years of shortage list threads, summarised so you do not have to read them. It is the sort of thing everyone half-believes and nobody writes down.
Kept the label from every vial. When the shortage status changed, having the paper trail made the conversation much shorter.
Asked for potency testing on the finished preparation. They had it. I had assumed they would not.
The five questions worth asking before you commit to any compounded arrangement.
Which facility, by name. Whether it is a 503A pharmacy or a 503B outsourcing facility. What concentration is on the label. What the beyond-use date is based on. Whether there is potency testing on the finished preparation rather than only on the starting material.
All five are answerable in one email and the pattern of what comes back is more informative than any of the individual answers. An organisation with a quality system finds these questions ordinary.
If two or three other people have done the same thing we might actually learn something. Alone it is an anecdote.
best — the order this archive was captured in
Removed the staff name. Facilities and clinics can be named here; individuals cannot.
Removed the staff name.
Disagreeing with this bit: registration is not equivalence, and the two get run together constantly.
the pharmacy and the prescriber are two separate questions
Push back: "compounded is fine because a pharmacy made it" skips every question this board exists to ask.
Concentration on the compounded vial was different from what I had been using and I nearly did the arithmetic on autopilot.
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.
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.
Right, and the concentration genuinely can differ from the branded product, which breaks people’s arithmetic.
ask what the beyond-use date is based on
the API source is the question nobody asks and everybody should
if a clinic will not name the facility, that is your answer
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