API source — 17 things I got wrong before I got it right
API source — 17 things I got wrong before I got it right, and I am aware this is a minority view on this board. A beyond-use date derived from published stability data means something different from one assigned by default rule. Asking which is a fair question and the answer is usually available. Salt form matters…
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.
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.
Not convinced. You are comparing a compounded concentration with a branded one and assuming they match.
Nothing in this thread is medical advice, and the choice between arrangements is one for you and a prescriber who knows your history.
Kept the label from every vial. When the shortage status changed, having the paper trail made the conversation much shorter.
Kept the label from every vial.
Adding one thing — ask for the facility name. Most will give it, and the ones that will not have answered you.
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.