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ForumsCompounding & FormulationCompounded sema potency testing — what worked for you? Page 3

Compounded sema potency testing — what worked for you?

Dr.PathRoch Thu, Aug 7, 2025 at 8:38 PM 13 replies 1,517 viewsPage 3 of 3
Dr.AddMedPHL
Senior Member
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Mar 2024
Philadelphia, PA
Aug 8, 2025 at 6:00 PM#11
newstart_MO said:
503A vs 503B compounding pharmacies for compounded supply — this distinction matters enormously: Feature 503A 503B Regulation State Board of Pharmacy…

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.

6 4FitDadDave, RunnerRach, TrialNerd_Beth and 3 others
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mel_PDX
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Dec 2024
Portland, OR
Aug 8, 2025 at 10:49 PM#12
EndoResFellow said:
Worth adding the genuine exception, because it is real and narrow: a change made for an identified patient where the prescriber determines it produces…

Thank you for spelling out the reasoning rather than just the conclusion. Adding it to my notes with a link back to this thread.

7 5Dr.KarenChen, Dr.NateNeph, PharmD_Rodriguez and 4 others
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PeptideChemSF
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Jan 2024
San Francisco, CA
Aug 9, 2025 at 3:38 AM#13
newstart_MO said:
503A vs 503B compounding pharmacies for compounded supply — this distinction matters enormously: Feature 503A 503B Regulation State Board of Pharmacy…

FDA inspection results for compounding pharmacies selling compounded supply: you can look up any 503B facility's FDA inspection history on the FDA website.

Check for: Form 483 observations (violations), warning letters, and recall history. A clean inspection record is a strong indicator of quality. My pharmacy has had 0 Form 483 observations in their last 4 inspections.

This is public information. Use it. Link: fda.gov/inspections-compliance-enforcement-and-criminal-investigations

Last edited: Aug 9, 2025 at 7:38 AM
8 6FDA_TrackerJim, ricardo_MIA, BrianDallas92 and 5 others
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wendy_avl
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Oct 2024
Asheville, NC
Aug 9, 2025 at 8:27 AM#14
Dr.PathRoch 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…

Vendor communication red flags for compounded supply:

  • Won't provide COA before purchase — walk away
  • Claims "100% pure" without analytical data — unrealistic
  • No physical address or phone number — accountability matters
  • Pushes you to buy more than you need — pressure tactics
  • Won't answer questions about their compounding process — transparency is key
  • Payment only via crypto or wire transfer — legitimate pharmacies accept cards

A legitimate compounding pharmacy operates like a healthcare business, not a gray market dealer.

9 7PharmHunterJen, TomTeleRx, DoseLogDan and 6 others
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Admin
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Aug 9, 2025 at 1:16 PM#15

Moderator note: a couple of off-topic posts removed.

10 8PeptideSynthNJ, Dr.KarenChen, Dr.NateNeph and 7 others
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