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ForumsCompounding & FormulationHas anyone dealt with fda warning letters to compounding pharmacies? Page 4

Has anyone dealt with fda warning letters to compounding pharmacies?

DebRD_ATL Thu, Oct 31, 2024 at 2:36 AM 50 replies 2,916 viewsPage 4 of 10
anders_CPH
Senior Member
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Feb 2024
Copenhagen, DK
Nov 3, 2024 at 11:02 AM#16

Adding the clinical framing, because it changes how the question reads.

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.

3 3CryptoCarl, MariaRD, AussieAnna
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TrialTracker_MD
Senior Member
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Jan 2024
Maryland
Nov 3, 2024 at 1:13 PM#17
Dr.AddMedPHL 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.

2 2stefan_berlin, Dr.EM_Chicago
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PeptideChemSF
Senior Member
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San Francisco, CA
Nov 3, 2024 at 3:24 PM#18

One thing that is still open after Dr.AddMedPHL’s answer:

How long did you give it before you decided it was working?

1 1FDA_TrackerJim
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RegAffairsDC
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Washington, DC
Nov 3, 2024 at 5:35 PM#19
TrialTracker_MD said:
Regarding compounded supply compounding legality: compounding pharmacies can legally produce semaglutide and tirzepatide while these drugs remain on…

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: Nov 3, 2024 at 7:35 PM
50 0sean_dublin, hannah_MT, Dr.SportsMedIN and 47 others
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mike_mod
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Nov 3, 2024 at 7:46 PM#20

Moderator note: the sourcing question belongs in the vendor section and has been split out.

Last edited: Nov 3, 2024 at 9:46 PM
28 3PurityPaulOR, MaxMetOK, MounjBrad and 25 others
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