[Question] Denmark — has anyone got a straight answer on 503B
Genuine question, and the title is the question: Denmark — has anyone got a straight answer on 503B. 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…
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.
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
Agreed — and the follow-up question is what the beyond-use date is based on.
the label on a compounded vial is a legal document, read it
a 503B has to register and report, so there is a paper trail to ask for
a 503B has to register and report, so there is a paper trail to ask for
Disagreeing with this bit: registration is not equivalence, and the two get run together constantly.
a telehealth intake that asks nothing has told you what it is
Asked for the beyond-use date basis and got a real answer with a stability reference attached. Not universal, apparently.
ask which facility, then ask for their testing
Small fix — 503B facilities register with the regulator; 503A pharmacies are licensed by the state board. Different mechanisms.