asked my compounder where the API comes from. long silence.
asked my compounder where the API comes from. long silence. 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",…
Left up. It describes an arrangement with specifics and it is honest about the jurisdiction.
do not assume the concentration matches the branded product
Paid noticeably more at one clinic than another for what turned out to be the same facility behind both.
the pharmacy and the prescriber are two separate questions
Yes. The shortage list is the legal hinge for the whole arrangement and its status is public.
Asked which facility and got a name straight away. Looked it up, found the registration, felt considerably better about the whole thing.
a 503B has to register and report, so there is a paper trail to ask for
Salt form matters for mass: a preparation specified as one salt and dosed as the free base gives you a different amount of peptide for the same number on the label.
Asked for potency testing on the finished preparation. They had it. I had assumed they would not.
That figure is the starting material purity, not the finished preparation potency. Two different tests.