[Discussion] the compounding gap was a symptom, not a solution
the compounding gap was a symptom, not a solution. It is the sort of thing everyone half-believes and nobody writes down. Asked which facility and got a name straight away. Looked it up, found the registration, felt considerably better about the whole thing. The intake asked me three questions and none of them were…
Not convinced. You are comparing a compounded concentration with a branded one and assuming they match.
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 the beyond-use date basis and got a real answer with a stability reference attached. Not universal, apparently.
Was there potency testing on the finished preparation, or only on the starting material?
salt forms are the recurring argument and the answer is boring
salt forms are the recurring argument and the answer is boring
burned_once_twice is right about the concentration trap. It breaks arithmetic that has been reliable for months.
Small fix — 503B facilities register with the regulator; 503A pharmacies are licensed by the state board. Different mechanisms.