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ForumsCompounding & FormulationFDA warning letters to compounding pharmacies — need advice Page 3

FDA warning letters to compounding pharmacies — need advice

lori_vegas Sat, Jun 7, 2025 at 10:56 AM 12 replies 1,308 viewsPage 3 of 3
JessicaM_2024
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Mar 2024
Portland, OR
Jun 7, 2025 at 3:11 PM#11

+1 to PharmacoVig_BOS. Especially the point about "Re: FDA warning letters to — the subgrou..." — I have seen the same in my own experience with FDA warning letters to.

Last edited: Jun 7, 2025 at 4:11 PM
22 17james_edin, FranDenver, Dr.BariatricHTX and 19 others
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jennifer_SEA
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Nov 2024
Seattle, WA
Jun 7, 2025 at 3:28 PM#12

Want to share my personal experience related to FDA warning letters to since I think it might help others in a similar situation.

I started my GLP-1 journey in March 2025 at 277 lbs with metabolic syndrome. My telehealth provider prescribed semaglutide 0.25mg to start.

Now, 18 months later: I am down 57 lbs, my labs have normalized, and my sleep apnea has improved dramatically. The FDA warning letters aspect specifically was something that made a big difference in my journey.

This forum was my go-to resource throughout.

43 15Dr.ReproEndo, lucas_SP_BR, lisa_labSD and 40 others
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NurseLeah_Nash
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Sep 2024
Nashville, TN
Jun 7, 2025 at 3:45 PM#13

lisa_labSD — that is really helpful context on FDA warning letters to. Follow-up question: did you change anything about your diet at the same time?

I am in a similar situation (month 2) and trying to set realistic expectations.

22 14PeptideSynthNJ, Dr.KarenChen, Dr.NateNeph and 19 others
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Dr.KarenChen
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San Francisco, CA
Jun 7, 2025 at 4:02 PM#14

To answer jennifer_SEA's question specifically:

From a clinical standpoint, FDA warning letters to is well-supported by the literature.

The short answer: follow the standard titration protocol and reassess at 4-6 weeks.

The longer answer involves pharmacokinetic considerations around steady-state concentrations, which I am happy to elaborate on if helpful.

28 24mike.trainer_LA, sarah_nash92, FitDadDave and 25 others
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mel_PDX
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Dec 2024
Portland, OR
Jun 7, 2025 at 4:19 PM#15

Saving this for reference. Top-tier content.

Last edited: Jun 7, 2025 at 10:19 PM
3 2RegAffairsDC, BiostatsBrad, PeptideSynthNJ
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