someone explain state board to me like I have not read a paper in years
Asking properly rather than in a comment on somebody else’s thread: someone explain state board to me like I have not read a paper in years. Asked for the beyond-use date basis and got a real answer with a stability reference attached. Not universal, apparently. Kept the label from every vial. When the shortage…
shortage status changes and the whole arrangement changes with it
Concentration on the compounded vial was different from what I had been using and I nearly did the arithmetic on autopilot.
Switched between two compounded preparations and the concentration on the label was different. Redid the arithmetic on paper before drawing anything.
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.
Correction: patient-specific refers to the prescription, not to a bespoke formulation. Common misreading and it changes the argument.
503A is patient-specific, 503B is outsourcing facility, they are not the same thing