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ForumsCompounding & FormulationCompounded sema potency testing — what worked for you? Page 2

Compounded sema potency testing — what worked for you?

Dr.PathRoch Thu, Aug 7, 2025 at 8:38 PM 13 replies 1,517 viewsPage 2 of 3
RetaRick_CA
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Aug 8, 2025 at 12:44 AM#6
SarahChen_PharmD said:
The shortage clause is the answer to the second question and it is a subtraction rather than an addition.

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.

Last edited: Aug 8, 2025 at 1:44 AM
32 10SkepticalSean, Dr.CardioMD, EndoResFellow and 29 others
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NicoleRaleigh
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Aug 8, 2025 at 2:20 AM#7
Dr.PathRoch said:
My pharmacy stopped supplying with three weeks notice and a letter that explained nothing, so I went and read the statute.

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 $151/month vs $1,341 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.

33 11MikeFit_NJ, InsuranceTom, WendyG_ATL and 30 others
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lisa_labSD
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Aug 8, 2025 at 3:56 AM#8
RetaRick_CA said:
A research-chemical supplier selling lyophilised powder labelled research use only is not compounding and is not claiming to.

Price comparison for compounded supply across sources I've used:

SourceMonthly CostTypePurity Verified
Brand (Ozempic)$950FDA-approvedN/A (pharma)
503B Compounding$130cGMP compoundedYes (in-house)
503A Compounding$100Patient-specificVaries
Research peptide$40Not for human useOften Janoshik

I use the 503B option — best balance of quality, cost, and legality. The brand price is insane but insurance can help if you qualify.

34 12Dr.PulmRoch, maya_sedona, stefan_berlin and 31 others
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quinn_sf
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Aug 8, 2025 at 5:32 AM#9

Following on from MeganSA_TX — 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: Aug 8, 2025 at 11:32 AM
35 13andrew_nyc, Dr.EndoEP, GraceAZ_72 and 32 others
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Dr.PathRoch
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Aug 8, 2025 at 1:11 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.

5 3Dr.MetabolicMD, RetaRick_CA, JenPlateau and 2 others
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