[Discussion] can we stop arguing about API source until somebody posts a number
Asking properly rather than in a comment on somebody else’s thread: can we stop arguing about API source until somebody posts a number.
Why "compounded" is not "generic", written out because the confusion is constant.
A generic is an approved product demonstrated to be bioequivalent to a reference. A compounded preparation is made for a patient or, in the case of an outsourcing facility, under a different regulatory route entirely. It carries no equivalence claim and it is not required to demonstrate one.
That is not a quality judgement. Plenty of compounded preparations are made carefully in facilities with real testing programmes. It is a statement about what has and has not been established, and the difference matters when people assume the two are interchangeable.
Compounded preparations are not approved products and carry no bioequivalence claim. That is a statement about regulatory category, not about quality.
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.
Would rather be corrected in public than confident in private.
best — the order this archive was captured in
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.
Nothing in this thread is medical advice, and the choice between arrangements is one for you and a prescriber who knows your history.
Disagree — a 503B being registered does not make its preparations equivalent to an approved product. Different regulatory category entirely.
Potency and sterility testing on the finished preparation are separate from any certificate covering the starting material. Ask which you are being shown.
Added a jurisdiction tag — the answers to this question are completely different in different countries.
Not convinced. You are comparing a compounded concentration with a branded one and assuming they match.