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ForumsCompounding & FormulationCompounded sema potency testing — 6 month update Page 2

Compounded sema potency testing — 6 month update

fiona_glasgow Tue, Sep 24, 2024 at 7:33 AM 14 replies 1,904 viewsPage 2 of 3
NeuroNate
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Sep 24, 2024 at 9:32 AM#6
Dr.RenalNash said:
They are two different exemptions from the same federal requirements and they buy different things.

I read this differently from Dr.RenalNash, 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.

3 6jason_paloalto, Dr.LeslieOBGYN, MikeNYC_runner
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BiostatsBrad
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Jul 2024
Durham, NC
Sep 24, 2024 at 10:18 AM#7
fiona_glasgow 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…

For compounded supply users considering compounded for the first time: here's a step-by-step guide:

  1. Get a prescription from your doctor (telehealth counts)
  2. Research 503B compounding pharmacies with good community reviews
  3. Verify their FDA registration and inspection history
  4. Request a COA for your specific compound before ordering
  5. Start with a 1-month supply to test
  6. Consider sending a sample to Janoshik for independent verification
  7. Track your response compared to brand (if you were on it previously)
Last edited: Sep 24, 2024 at 11:18 AM
4 7Dr.BariatricHTX, LindaRN_retired, tommy_boulder and 1 other
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TinaHashiRN
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Sep 2024
Raleigh, NC
Sep 24, 2024 at 11:04 AM#8
NeuroNate said:
A research-chemical supplier selling lyophilised powder labelled research use only is not compounding and is not claiming to.

Compounded has been just as effective for me. If compounded supply is the concern, the COA from my 503B pharmacy shows 99.1% purity. Verified by Janoshik.

5 8Dr.Martinez, mike_mod, SarahChen_PharmD and 2 others
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Sigma-Aldrich — Research-Grade Standards

Certified reference materials, analytical reagents, and research-grade standards for peptide verification. Trusted by laboratories worldwide.

Shop Reference Standards
marcus_mpls
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Nov 2024
Minneapolis, MN
Sep 24, 2024 at 11:50 AM#9

Following on from NauseaFreeNow — 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?

6 9Dr.PathRoch, mona_PHX, andrew_nyc and 3 others
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fiona_glasgow
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Aug 2024
Glasgow, UK
Sep 24, 2024 at 3:29 PM#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.

26 1NeuroNate, JessicaH_TX, KevinCompounds and 23 others
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