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ForumsCompounding & FormulationEndotoxin testing in compounded injectables — anyone have experience? Page 2

Endotoxin testing in compounded injectables — anyone have experience?

lucas_SP_BR Tue, Nov 12, 2024 at 2:58 AM 8 replies 1,672 viewsPage 2 of 2
Dr.PeteFamMed
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Nov 12, 2024 at 5:03 AM#6
Dr.SportsMedIN said:
The shortage clause is the answer to the second question and it is a subtraction rather than an addition.

I read this differently from Dr.SportsMedIN, on substance rather than tone. 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.

46 24hyun_seoul, jim_asheville, matt_MKE and 43 others
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VendorMark
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Nov 12, 2024 at 5:52 AM#7
lucas_SP_BR said:
My pharmacy stopped supplying with three weeks notice and a letter that explained nothing, so I went and read the statute.

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

Lyophilized (unreconstituted): typically 6 months from compounding date
Reconstituted with BAC water: typically 28-30 days refrigerated
Reconstituted with sterile water: typically 24 hours (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.

47 0KristenIndy, MarkLI_maint, Dr.PeteFamMed and 44 others
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PharmD_Rodriguez
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Nov 12, 2024 at 6:41 AM#8
Dr.PeteFamMed said:
A research-chemical supplier selling lyophilised powder labelled research use only is not compounding and is not claiming to.

Compounded semaglutide formulations for compounded supply: some pharmacies add ingredients like B12, L-carnitine, or BPC-157 to their semaglutide preparations. Are these beneficial or marketing gimmicks?

My take: B12 addition has some logic (GLP-1s can deplete B12). L-carnitine evidence is weak. BPC-157 for GI protection is theoretically interesting but unproven. I prefer straight semaglutide with no additives — fewer variables, cleaner data on what's working.

48 1robert_kc, dan_philly, MeganSA_TX and 45 others
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tane_welly
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Wellington, NZ
Nov 12, 2024 at 7:30 AM#9

Following on from LondonLisa — and this may be the naive question:

What actually distinguishes 503A from 503B, in terms of what each may make and from what starting material?

Last edited: Nov 12, 2024 at 10:30 AM
49 2marco_milano, pam_columbus, nick_SD_fit and 46 others
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lucas_SP_BR
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Nov 12, 2024 at 11:25 AM#10

Reporting back.

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.

43 18tampaLisa73, KarenAZ_mom, zoe_NC and 40 others
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