genuine question about 503B that I am slightly embarrassed to ask
genuine question about 503B that I am slightly embarrassed to ask — that is what I am asking, and I have already read the wiki twice. Switched between two compounded preparations and the concentration on the label was different. Redid the arithmetic on paper before drawing anything. Paid noticeably more at one clinic…
Compounded preparations are not approved products and carry no bioequivalence claim. That is a statement about regulatory category, not about quality.
Compounded preparations are not approved products and carry no bioequivalence claim.
Agreed — and the follow-up question is what the beyond-use date is based on.
Agreed on potency testing of the finished preparation. That is a different question from the purity of the starting material.
ask what the beyond-use date is based on
do not assume the concentration matches the branded product
Small fix — 503B facilities register with the regulator; 503A pharmacies are licensed by the state board. Different mechanisms.
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.
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.
That figure is the starting material purity, not the finished preparation potency. Two different tests.