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ForumsDosing & ProtocolsCompounded sema dosing calculator — what worked for you? Page 2

Compounded sema dosing calculator — what worked for you?

alex_tucson Sat, Nov 23, 2024 at 5:29 PM 15 replies 1,958 viewsPage 2 of 3
NeuroNate
Senior Member
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Dec 2023
Chicago, IL
Nov 24, 2024 at 8:55 PM#6
PurityPaulOR 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.

47 17jason_paloalto, Dr.LeslieOBGYN, MikeNYC_runner and 44 others
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quinn_sf
Member
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Jun 2024
San Francisco, CA
Nov 25, 2024 at 7:52 AM#7
alex_tucson 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…

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 partially resolved shortage, tirzepatide still in shortage. This directly impacts compounding availability.

Last edited: Nov 25, 2024 at 1:52 PM
46 16Dr.PathRoch, mona_PHX, andrew_nyc and 43 others
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sarah_TO
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Sep 2024
Toronto, CA
Nov 25, 2024 at 6:49 PM#8
NeuroNate said:
A research-chemical supplier selling lyophilised powder labelled research use only is not compounding and is not claiming to.

Compounding pharmacy customer here with experience relevant to compounded supply.

I've ordered from 4 different compounding pharmacies over the past 14 months. The quality variation is real — purity ranged from 94% to 101% of label claim based on independent Janoshik testing.

My current compounder (a 503B facility) has been consistently 98-101% purity across 8 orders. I pay $139/month vs $1,389 for brand. The savings are substantial and the product is equivalent in my experience.

Re: compounded supply — this applies whether you're using brand or compounded. The clinical principles are the same.

45 15GraceAZ_72, carl_compliance, DanielChem_CHI and 42 others
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NicoleRaleigh
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Aug 2024
Raleigh, NC
Nov 26, 2024 at 5:46 AM#9

A 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?

44 14VendorMark, COA_Karl, MikeFit_NJ and 41 others
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alex_tucson
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May 2024
Tucson, AZ
Nov 28, 2024 at 10:22 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.

40 13FDA_TrackerJim, ricardo_MIA, BrianDallas92 and 37 others
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