three years of telehealth threads, summarised so you do not have to read them
Posting this as a discussion rather than a claim: three years of telehealth threads, summarised so you do not have to read them. 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…
Compounded preparations are not approved products and carry no bioequivalence claim. That is a statement about regulatory category, not about quality.
a telehealth intake that asks nothing has told you what it is
Compounded preparations are not approved products and carry no bioequivalence claim.
Agreed — and the follow-up question is what the beyond-use date is based on.
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.
What is the beyond-use date and what is it based on?
That is not what patient-specific means. It refers to the prescription, not to a customisation of the formula.
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.
That is not what patient-specific means.
Adding one thing — ask for the facility name. Most will give it, and the ones that will not have answered you.