the telehealth question that gets asked weekly, answered properly
the telehealth question that gets asked weekly, answered properly. It is the sort of thing everyone half-believes and nobody writes down. Compounded preparations are not approved products and carry no bioequivalence claim. That is a statement about regulatory category, not about quality. The shortage list is the…
Concentration on the compounded vial was different from what I had been using and I nearly did the arithmetic on autopilot.
the API source is the question nobody asks and everybody should
Not convinced. You are comparing a compounded concentration with a branded one and assuming they match.
compounded is not generic, there is no equivalence claim
compounded is not generic, there is no equivalence claim
Adding one thing — ask for the facility name. Most will give it, and the ones that will not have answered you.
Paid noticeably more at one clinic than another for what turned out to be the same facility behind both.
Disagree — a 503B being registered does not make its preparations equivalent to an approved product. Different regulatory category entirely.
Switched between two compounded preparations and the concentration on the label was different. Redid the arithmetic on paper before drawing anything.
Switched between two compounded preparations and the concentration on the label was different.
This is the distinction the whole board runs on. Everything else follows from it.
This is the distinction the whole board runs on.
Agreed — and the follow-up question is what the beyond-use date is based on.