the shortage list came off and my pharmacy stopped overnight
the shortage list came off and my pharmacy stopped overnight. 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.
Please do not ask me what dose you should be on. I genuinely do not know and neither does anyone else here.
best — the order this archive was captured in
Left up. It describes an arrangement with specifics and it is honest about the jurisdiction.
Why "compounded" is not "generic", written out because the confusion is constant.
A generic is an approved product demonstrated to be bioequivalent to a reference. A compounded preparation is made for a patient or, in the case of an outsourcing facility, under a different regulatory route entirely. It carries no equivalence claim and it is not required to demonstrate one.
That is not a quality judgement. Plenty of compounded preparations are made carefully in facilities with real testing programmes. It is a statement about what has and has not been established, and the difference matters when people assume the two are interchangeable.
Switched between two compounded preparations and the concentration on the label was different. Redid the arithmetic on paper before drawing anything.
the label on a compounded vial is a legal document, read it
the label on a compounded vial is a legal document, read it
lipid_panel_larry is right about the concentration trap. It breaks arithmetic that has been reliable for months.
Small fix — 503B facilities register with the regulator; 503A pharmacies are licensed by the state board. Different mechanisms.
Small fix — 503B facilities register with the regulator; 503A pharmacies are licensed by the state board.
Disagreeing with this bit: registration is not equivalence, and the two get run together constantly.
Yes. The shortage list is the legal hinge for the whole arrangement and its status is public.
Who is the prescriber, and are they the same organisation as the pharmacy?
Same view. If the intake asked you nothing, the intake was a formality and you should factor that in.
Yes.
Agreed — and the follow-up question is what the beyond-use date is based on.
This. Compounded preparations carry no equivalence claim, and treating them as generics is a category error people make constantly.
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