[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…
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