dan_philly said:Worth adding the genuine exception, because it is real and narrow: a change made for an identified patient where the prescriber determines it produces…
This is my experience too, for whatever a second data point is worth. Nothing to add that would improve it.
dan_philly said:Worth adding the genuine exception, because it is real and narrow: a change made for an identified patient where the prescriber determines it produces…
Adding the part of the answer the thread has not reached. Resolution therefore closed the doors unevenly, and the asymmetry follows from the bulks lists. For 503B the shortage clause was the only route to these molecules, so that route shut completely. A 503A pharmacy can still argue a doorway via "component of an approved drug" — but only for the substance in the form present in the approved product, which is exactly where the base-versus-salt argument lives, and it does nothing about the copy restriction, which came back into force on resolution.
dan_philly said:Worth adding the genuine exception, because it is real and narrow: a change made for an identified patient where the prescriber determines it produces…
Reconstitution tip for anyone mixing dosing arithmetic from lyophilized powder: use bacteriostatic water, NOT sterile water. The benzyl alcohol in BAC water preserves multi-dose vials for up to 28 days.
Inject the water slowly down the side of the vial. NEVER shake — gentle swirling only until fully dissolved. Should be crystal clear with no particles.
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Shop Reference StandardsA narrower follow-up, since the general answer is now clear:
Why a shortage listing created a legal pathway at all, since a shortage is a supply fact rather than a permission?
DataDave said:Reconstitution tip for anyone mixing dosing arithmetic from lyophilized powder: use bacteriostatic water, NOT sterile water.
For anyone reconstituting dosing arithmetic peptides: the water-to-powder ratio determines your concentration. Here's my reference:
| Vial Size | BAC Water | Concentration | 0.25mg Dose |
|---|---|---|---|
| 5mg | 2mL | 2.5mg/mL | 10 units |
| 5mg | 2.5mL | 2mg/mL | 12.5 units |
| 10mg | 2mL | 5mg/mL | 5 units |
| 10mg | 3mL | 3.33mg/mL | 7.5 units |
More water = easier to measure small doses but vial runs out faster. Find the balance that works for your dose.