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ForumsCompounding & FormulationCompounded peptide reconstitution water — looking for input Page 2

Compounded peptide reconstitution water — looking for input

maria_elpaso Fri, Oct 18, 2024 at 11:14 PM 33 replies 2,392 viewsPage 2 of 7
quinn_sf
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Oct 19, 2024 at 12:58 AM#6

Adding the numbers, since they settle part of this. Two things anyone can check: a state licence number for a 503A, and an FDA outsourcing-facility registration for a 503B. Both are publicly searchable, and a pharmacy unwilling to give you either has answered the question.

5 8tane_welly, Dr.PathRoch, mona_PHX and 2 others
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SurmountFan_IN
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Oct 19, 2024 at 1:38 AM#7

A narrower follow-up, since the general answer is now clear:

How much material I am losing to dead space, and whether that explains why a 10mg vial gives me nine usable draws rather than ten?

Last edited: Oct 19, 2024 at 2:38 AM
6 9AttorneyGrant, DebRD_ATL, KristenIndy and 3 others
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Dr.NateNeph
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Oct 19, 2024 at 2:18 AM#8
quinn_sf said:
Two things anyone can check: a state licence number for a 503A, and an FDA outsourcing-facility registration for a 503B.

Adding the part of the answer the thread has not reached. The shortage clause is the answer to the second question and it is a subtraction rather than an addition. Both exemptions forbid compounding something that is essentially a copy of a commercially available approved product. A product FDA has listed as in shortage is not treated as commercially available, so listing removed the objection that otherwise blocked compounding. It never created a permission; it withdrew a prohibition, which is why it evaporated the moment the supply fact changed.

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maria_elpaso
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Oct 19, 2024 at 2:58 AM#9

OP back with an update, since a thread like this is useless without one.

My error was treating units as a mass. Once I wrote mg/ml on the vial in marker and worked in millilitres first, the two of us got the same answer.

Last edited: Oct 19, 2024 at 8:58 AM
8 11HPLC_Greg, LibrarianMeg, bri_stats and 5 others
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NurseLeah_Nash
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Oct 19, 2024 at 6:10 AM#10
Dr.NateNeph said:
The shortage clause is the answer to the second question and it is a subtraction rather than an addition.

Agreed, and it is worth saying that rounding to the nearest whole unit is usually acceptable at maintenance doses and is not acceptable at the bottom of a ladder, where one unit can be a fifth of the intended dose.

14 14Dr.NateNeph, PharmD_Rodriguez, julia.endo and 11 others
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