three years of 503A threads, summarised so you do not have to read them
three years of 503A threads, summarised so you do not have to read them — a position I have arrived at slowly and would like tested. 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…
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.
Agreed on potency testing of the finished preparation. That is a different question from the purity of the starting material.
That figure is the starting material purity, not the finished preparation potency. Two different tests.
shortage status changes and the whole arrangement changes with it
The intake asked me three questions and none of them were about my history. That told me everything I needed to know about the model.
potency testing on the finished preparation is the thing to ask for
On concentration, which is where I see people actually get hurt.
prior_auth_pain is right about the concentration trap. It breaks arithmetic that has been reliable for months.
the API source is the question nobody asks and everybody should
compounded is not generic, there is no equivalence claim