[Meta] the compounding rule is doing its job and people should stop complaining
the compounding rule is doing its job and people should stop complaining. This affects how posts get sorted and removed, so it belongs in the open.
Compounded preparations are not approved products and carry no bioequivalence claim. That is a statement about regulatory category, not about quality.
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.
On concentration, which is where I see people actually get hurt.
A compounded vial can be filled at a different concentration from the branded product you were previously using. If you carry over your old arithmetic — same number of units, different mg/mL — you draw a different amount and may not notice for weeks.
Read the label every time you switch. Redo the arithmetic on paper. Write the concentration on the vial. It is the same habit c/reconstitution keeps preaching and this is the case where it actually bites.
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
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.
the label on a compounded vial is a legal document, read it
potency testing on the finished preparation is the thing to ask for
What did the intake actually ask you?
Push back: "compounded is fine because a pharmacy made it" skips every question this board exists to ask.
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.
Added a jurisdiction tag — the answers to this question are completely different in different countries.
shortage status changes and the whole arrangement changes with it
503A or 503B — do you know which?