[Question] Australia — has anyone got a straight answer on state board
Australia — has anyone got a straight answer on state board — that is what I am asking, and I have already read the wiki twice.
Potency and sterility testing on the finished preparation are separate from any certificate covering the starting material. Ask which you are being shown.
Nothing in this thread is medical advice, and the choice between arrangements is one for you and a prescriber who knows your history.
Asked which facility and got a name straight away. Looked it up, found the registration, felt considerably better about the whole thing.
That is everything I have. The rest is opinion and I have tried to keep it out.
best — the order this archive was captured in
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.
A beyond-use date derived from published stability data means something different from one assigned by default rule.
Adding one thing — ask for the facility name. Most will give it, and the ones that will not have answered you.
the API source is the question nobody asks and everybody should
Kept the label from every vial. When the shortage status changed, having the paper trail made the conversation much shorter.
Kept the label from every vial.
ruben_cabrera is right about the concentration trap. It breaks arithmetic that has been reliable for months.
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.
Did they name the facility?
the pharmacy and the prescriber are two separate questions
Salt form matters for mass: a preparation specified as one salt and dosed as the free base gives you a different amount of peptide for the same number on the label.
potency testing on the finished preparation is the thing to ask for
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.
if a clinic will not name the facility, that is your answer
ask which facility, then ask for their testing
the label on a compounded vial is a legal document, read it
Careful. Naming a clinic without describing what actually happened turns this into a different kind of thread.
Correction: patient-specific refers to the prescription, not to a bespoke formulation. Common misreading and it changes the argument.
compounded is not generic, there is no equivalence claim
That figure is the starting material purity, not the finished preparation potency. Two different tests.
Compounded preparations are not approved products and carry no bioequivalence claim. That is a statement about regulatory category, not about quality.
Reminder that nothing here is medical advice and this board cannot tell you which arrangement to choose.
Switched between two compounded preparations and the concentration on the label was different. Redid the arithmetic on paper before drawing anything.
- 1if a clinic will not name the facility, that is your answer9 comments in this branch · started by u/prior_auth_pain