my compounded vial arrived at a different concentration than last month
The title is the argument: my compounded vial arrived at a different concentration than last month. Here is the rest of it. 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…
Compounded preparations are not approved products and carry no bioequivalence claim. That is a statement about regulatory category, not about quality.
Small fix — 503B facilities register with the regulator; 503A pharmacies are licensed by the state board. Different mechanisms.
Small fix — 503B facilities register with the regulator; 503A pharmacies are licensed by the state board.
Disagreeing with this bit: registration is not equivalence, and the two get run together constantly.
ask what the beyond-use date is based on
the shortage list is the whole legal hinge and people skip it
Was there potency testing on the finished preparation, or only on the starting material?
Concentration on the compounded vial was different from what I had been using and I nearly did the arithmetic on autopilot.
salt forms are the recurring argument and the answer is boring
potency testing on the finished preparation is the thing to ask for