[Question] Spain — has anyone got a straight answer on 503B
Genuine question, and the title is the question: Spain — has anyone got a straight answer on 503B. 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…
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.
Yes — asking which facility, by name, is the single most useful question and most clinics will answer it.
salt forms are the recurring argument and the answer is boring
Agreed. The 503A versus 503B distinction changes who is allowed to make what, and almost every confused thread here starts by ignoring it.
That is not what patient-specific means. It refers to the prescription, not to a customisation of the formula.
Switched between two compounded preparations and the concentration on the label was different. Redid the arithmetic on paper before drawing anything.