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ForumsCompounding & FormulationPeptide degradation products — what worked for you? Page 2

Peptide degradation products — what worked for you?

mona_PHX Fri, Aug 30, 2024 at 3:56 AM 13 replies 1,843 viewsPage 2 of 3
TrialTracker_MD
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Aug 30, 2024 at 1:37 PM#6
LipidDoc_ATL said:
They are two different exemptions from the same federal requirements and they buy different things.

I read this differently from LipidDoc_ATL, 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.

12 15Dr.EM_Chicago, pete_RVA, CarlaRPh_TPA and 9 others
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Dr.PeteFamMed
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Aug 30, 2024 at 5:26 PM#7
mona_PHX said:
My pharmacy stopped supplying with three weeks notice and a letter that explained nothing, so I went and read the statute.

Regarding compounded supply compounding legality: compounding pharmacies can legally produce semaglutide and tirzepatide while these drugs remain on the FDA shortage list. If/when the shortage resolves, the legal landscape may change.

Stay informed. The FDA shortage list is updated regularly. Current status as of my last check: semaglutide still in shortage, tirzepatide removed from shortage list. This directly impacts compounding availability.

Last edited: Aug 30, 2024 at 6:26 PM
13 16tommy_boulder, hyun_seoul, jim_asheville and 10 others
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Dr.RenalNash
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Aug 30, 2024 at 9:16 PM#8
TrialTracker_MD said:
A research-chemical supplier selling lyophilised powder labelled research use only is not compounding and is not claiming to.

Compounding pharmacy response time test for compounded supply: I email customer service at odd hours to test responsiveness. A pharmacy that can't answer questions promptly is a red flag.

My current pharmacy: average response time 2 hours. They answered my questions about storage conditions thoroughly and professionally.

Communication quality is a proxy for operational quality. A pharmacy that communicates well is likely manufacturing well too.

Last edited: Aug 31, 2024 at 2:16 AM
14 17Dr.NutriCornell, pam_stl, wei_SG and 11 others
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MarkLI_maint
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Jun 2024
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Aug 31, 2024 at 1:06 AM#9

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

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

15 18LibrarianMeg, bri_stats, pete_manc_UK and 12 others
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mona_PHX
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Phoenix, AZ
Aug 31, 2024 at 7:28 PM#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.

47 22MariaRD, AussieAnna, BethLabQueen and 44 others
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