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ForumsBuyer BewareHow do I even know if my compounding pharmacy is legit — November 2025 Page 2

How do I even know if my compounding pharmacy is legit — November 2025

VanRx_Mike Mon, Jul 22, 2024 at 6:25 PM 38 replies 2,586 viewsPage 2 of 8
Dr.GutHealth
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Jul 22, 2024 at 7:30 PM#6
Dr.ObesityLA said:
Resolution therefore closed the doors unevenly, and the asymmetry follows from the bulks lists.

Pushing back on Dr.ObesityLA here. 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.

Last edited: Jul 23, 2024 at 12:30 AM
48 18VanRx_Mike, steve_okc, dave_SLC and 45 others
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BiostatsBrad
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Jul 2024
Durham, NC
Jul 22, 2024 at 7:55 PM#7
VanRx_Mike 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…

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 3 inspections.

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

47 17Dr.BariatricHTX, LindaRN_retired, tommy_boulder and 44 others
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LipidDoc_ATL
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Apr 2024
Atlanta, GA
Jul 22, 2024 at 8:20 PM#8
Dr.GutHealth said:
A research-chemical supplier selling lyophilised powder labelled research use only is not compounding and is not claiming to.

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)
46 16AttorneyGrant, DebRD_ATL, KristenIndy and 43 others
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Sigma-Aldrich — Research-Grade Standards

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JessicaM_2024
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Mar 2024
Portland, OR
Jul 22, 2024 at 8:45 PM#9

Following on from fiona_VT — 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?

45 15Dr.PainCLE, mike_mealprep, NicoleRaleigh and 42 others
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VanRx_Mike
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Vancouver, CA
Jul 22, 2024 at 10:47 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.

Last edited: Jul 23, 2024 at 1:47 AM
9 7mike_mod, SarahChen_PharmD, sarah.morrison and 6 others
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