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ForumsCompounding & FormulationMy vial looks cloudy - throw it out?? — 6 month update Page 2

My vial looks cloudy - throw it out?? — 6 month update

A1cHero_PHX Wed, Mar 26, 2025 at 2:35 PM 14 replies 1,750 viewsPage 2 of 3
pete_manc_UK
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Mar 27, 2025 at 12:54 AM#6
Dr.SleepRoch said:
They are two different exemptions from the same federal requirements and they buy different things.

This is where I part company with the consensus forming above. A research-chemical supplier selling lyophilised powder labelled research use only is not compounding and is not claiming to. It is a different legal universe with no pharmacy oversight, no patient relationship and no content guarantee, and conflating the two in these threads helps nobody.

3 6TrialNerd_Beth, HPLC_Greg, LibrarianMeg
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wendy_avl
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Oct 2024
Asheville, NC
Mar 27, 2025 at 4:58 AM#7
A1cHero_PHX said:
Two pharmacies quoted me last year, one describing itself as 503A and one as 503B, and I assumed 503B just meant bigger until both stopped within…

Beyond-use dating (BUD) for compounded supply compounded products:

Lyophilized (unreconstituted): typically 9 months from compounding date
Reconstituted with BAC water: typically 28-30 days refrigerated
Reconstituted with sterile water: typically 7 days (no preservative!)

Always use BAC water for multi-dose vials. Sterile water has no preservative and supports bacterial growth after first puncture. This is a common and potentially dangerous mistake.

Last edited: Mar 27, 2025 at 10:58 AM
4 7DoseLogDan, SleepFixSam, PurityPaulOR and 1 other
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andrew_nyc
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New York, NY
Mar 27, 2025 at 9:02 AM#8
pete_manc_UK said:
A research-chemical supplier selling lyophilised powder labelled research use only is not compounding and is not claiming to.

I have been on both brand and compounded, and in the context of compounded supply, my experience has been equivalent with both. The key is finding a reliable 503B pharmacy with independent testing.

Last edited: Mar 27, 2025 at 2:02 PM
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raj_cambridge
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Jun 2024
Cambridge, MA
Mar 27, 2025 at 1:06 PM#9

Following on from Dr.GutHealth — and this may be the naive question:

Why a shortage listing created a legal pathway at all, since a shortage is a supply fact rather than a permission?

Last edited: Mar 27, 2025 at 2:06 PM
6 9PharmHunterJen, TomTeleRx, DoseLogDan and 3 others
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A1cHero_PHX
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Phoenix, AZ
Mar 28, 2025 at 8:36 AM#10

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

The bulks-list asymmetry was the piece I had missed entirely. It explains why one of my two pharmacies is still arguing it can supply and the other simply stopped.

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