[Discussion] we are measuring compounding at the wrong time and calling it noise
we are measuring compounding at the wrong time and calling it noise. Making the case below, and I expect to lose some of it in the comments.
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.
Not medical advice, obviously, and nothing here is approved for human use. One person with a spreadsheet.
best — the order this archive was captured in
Nothing in this thread is medical advice, and the choice between arrangements is one for you and a prescriber who knows your history.
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if a clinic will not name the facility, that is your answer
ask what the beyond-use date is based on
salt forms are the recurring argument and the answer is boring
503A is patient-specific, 503B is outsourcing facility, they are not the same thing
Removed the staff name. Facilities and clinics can be named here; individuals cannot.
Disagree — a 503B being registered does not make its preparations equivalent to an approved product. Different regulatory category entirely.
Disagree — a 503B being registered does not make its preparations equivalent to an approved product.
Disagreeing with this bit: registration is not equivalence, and the two get run together constantly.
Did they name the facility?
potency testing on the finished preparation is the thing to ask for
Careful. Naming a clinic without describing what actually happened turns this into a different kind of thread.
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.
That is not what patient-specific means. It refers to the prescription, not to a customisation of the formula.
Potency and sterility testing on the finished preparation are separate from any certificate covering the starting material. Ask which you are being shown.
Potency and sterility testing on the finished preparation are separate from any certificate covering the starting material.
Adding one thing — ask for the facility name. Most will give it, and the ones that will not have answered you.
- 1503A is patient-specific, 503B is outsourcing facility, they are not the…6 comments in this branch · started by u/maren_sorensen