andrew_nyc said:BiostatsBrad said: ...but the FDA says semaglutide...
Same position here, arrived at the long way round. Worth adding the genuine exception, because it is real and narrow: a change made for an identified patient where the prescriber determines it produces a significant clinical difference for that patient. A grid of fixed doses offered to everybody is not that, whatever the intake form says.
FDA_TrackerJim said:Two things anyone can check: a state licence number for a 503A, and an FDA outsourcing-facility registration for a 503B.
Bookmarking. The distinction being drawn above is the one nobody else makes. I will report back once I have actually tried it.
From the other side of the consultation, briefly. It helps to say which part of this you are uncertain about. A precise question gets a precise answer; a general one gets everybody’s favourite anecdote.
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Browse GL BiochemNurseLeah_Nash said:It helps to say which part of this you are uncertain about.
Agreed, and the enforcement dates were staggered by category — 503A first, 503B a few weeks later — because outsourcing facilities have manufactured inventory and clinic contracts to unwind while a 503A makes to order.
If somebody has the primary source to hand I would rather cite it than paraphrase it.