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ForumsSemaglutide (Ozempic / Wegovy)Has anyone dealt with my compounded sema journey? Page 2

Has anyone dealt with my compounded sema journey?

Dr.PeteFamMed Wed, Jun 12, 2024 at 9:15 PM 11 replies 2,020 viewsPage 2 of 3
LibrarianMeg
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Jun 12, 2024 at 10:33 PM#6
Dr.LipidDallas said:
They are two different exemptions from the same federal requirements and they buy different things.

I read this differently from Dr.LipidDallas, 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.

14 9Dr.NateNeph, PharmD_Rodriguez, julia.endo and 11 others
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PharmacoVig_BOS
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Jun 12, 2024 at 11:03 PM#7
Dr.PeteFamMed said:
My pharmacy stopped supplying with three weeks notice and a letter that explained nothing, so I went and read the statute.

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: Jun 13, 2024 at 2:03 AM
13 8Dr.GutHealth, amsterdam_pete, LondonLisa and 10 others
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PeptideChemSF
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Jun 12, 2024 at 11:33 PM#8
LibrarianMeg said:
A research-chemical supplier selling lyophilised powder labelled research use only is not compounding and is not claiming to.

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.

12 7FDA_TrackerJim, ricardo_MIA, BrianDallas92 and 9 others
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SandraNC_45
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Jun 13, 2024 at 12:03 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?

Last edited: Jun 13, 2024 at 5:03 AM
11 6mike_mealprep, NicoleRaleigh, james_edin and 8 others
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Dr.PeteFamMed
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Jun 13, 2024 at 2:27 AM#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.

Last edited: Jun 13, 2024 at 3:27 AM
35 8FranDenver, Dr.BariatricHTX, LindaRN_retired and 32 others
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