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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
anders_CPH
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Feb 2024
Copenhagen, DK
Sep 24, 2024 at 9:32 AM#6
VendorMark said:
The shortage clause is the answer to the second question and it is a subtraction rather than an addition.

I read this differently from VendorMark, 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.

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Dr.PulmRoch
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Jun 2024
Rochester, MN
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)
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carl_compliance
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Nov 2024
Raleigh, NC
Sep 24, 2024 at 11:04 AM#8
anders_CPH 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 partially resolved shortage, tirzepatide still in shortage. This directly impacts compounding availability.

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hank_denver
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Sep 2024
Denver, CO
Sep 24, 2024 at 11:50 AM#9

Following on from robert_kc — 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: Sep 24, 2024 at 3:50 PM
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fiona_glasgow
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Glasgow, UK
Sep 24, 2024 at 3:29 PM#10

Closing the loop on my own question.

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.

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