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ForumsSemaglutide (Ozempic / Wegovy)Compounded sema batch testing results — need advice Page 2

Compounded sema batch testing results — need advice

steve_okc Fri, Aug 30, 2024 at 7:49 AM 14 replies 1,952 viewsPage 2 of 3
PeptideChemSF
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Aug 30, 2024 at 9:21 PM#6
DataDave said:
They are two different exemptions from the same federal requirements and they buy different things.

I read this differently from DataDave, 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.

31 1steve_okc, dave_SLC, FDA_TrackerJim and 28 others
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TirzTom
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Aug 31, 2024 at 2:43 AM#7
steve_okc 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)
30 0tom_AK, josh_phd_bmore, roxy_nash and 27 others
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Dr.PeteFamMed
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Minneapolis, MN
Aug 31, 2024 at 8:05 AM#8
PeptideChemSF said:
A research-chemical supplier selling lyophilised powder labelled research use only is not compounding and is not claiming to.

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.

29 24LindaRN_retired, tommy_boulder, hyun_seoul and 26 others
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Janoshik Analytical — Independent Testing

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mia_MS2
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Jun 2026
Ann Arbor, MI
Aug 31, 2024 at 1:27 PM#9

One thing that is still open after SleepFixSam’s answer:

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

28 23steve_okc, dave_SLC, FDA_TrackerJim and 25 others
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steve_okc
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Jul 2024
Oklahoma City, OK
Sep 1, 2024 at 3:14 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.

38 11KetoKyle, CanadaChris, ZaraB_AL and 35 others
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