does API source actually matter or is it forum lore at this point
Genuine question, and the title is the question: does API source actually matter or is it forum lore at this point.
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.
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
Potency and sterility testing on the finished preparation are separate from any certificate covering the starting material. Ask which you are being shown.
Switched between two compounded preparations and the concentration on the label was different. Redid the arithmetic on paper before drawing anything.
Was there potency testing on the finished preparation, or only on the starting material?
A beyond-use date derived from published stability data means something different from one assigned by default rule. Asking which is a fair question and the answer is usually available.
Asked for the beyond-use date basis and got a real answer with a stability reference attached. Not universal, apparently.