how much of what we believe about 503B actually comes from compounding threads
Genuine question, and the title is the question: how much of what we believe about 503B actually comes from compounding threads. 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. Asked which facility and got a name straight away.…
A 503A pharmacy compounds for an identified patient against a prescription. A 503B outsourcing facility registers with the regulator, may produce without patient-specific prescriptions, and is subject to current good manufacturing practice requirements. The two are governed differently and the difference is not cosmetic.
Asked for potency testing on the finished preparation. They had it. I had assumed they would not.
Kept the label from every vial. When the shortage status changed, having the paper trail made the conversation much shorter.
do not assume the concentration matches the branded product
That figure is the starting material purity, not the finished preparation potency. Two different tests.
What did the intake actually ask you?
What did the intake actually ask you?
Disagreeing with this bit: registration is not equivalence, and the two get run together constantly.
What concentration is on the label, and does it match what you were expecting?