unpopular opinion: most of what gets said here about state board is guesswork
unpopular opinion: most of what gets said here about state board is guesswork. Not a hot take, just something I have not seen said plainly here.
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.
That is everything I have. The rest is opinion and I have tried to keep it out.
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.
Kept the label from every vial. When the shortage status changed, having the paper trail made the conversation much shorter.
Disagree — a 503B being registered does not make its preparations equivalent to an approved product. Different regulatory category entirely.
That figure is the starting material purity, not the finished preparation potency. Two different tests.