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ForumsBuyer BewareHow do I even know if my compounding pharmacy is legit — looking for input Page 3

How do I even know if my compounding pharmacy is legit — looking for input

lisa_labSD Mon, May 26, 2025 at 9:27 AM 14 replies 1,622 viewsPage 3 of 3
Dr.BariatricHTX
Senior Member
1,456
7,234
Feb 2024
Houston, TX
May 29, 2025 at 3:54 PM#11
Dr.LeslieOBGYN said:
I have been on both brand and compounded, and in the context of compounded supply, my experience has been equivalent with both.

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 1 Form 483 observations in their last 2 inspections.

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

14 12CarlaRPh_TPA, steph_laguna, fiona_glasgow and 11 others
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kim_atl_prep
Member
312
1,345
Aug 2024
Atlanta, GA
May 30, 2025 at 9:04 AM#12
stefan_berlin said:
Agreed, and the enforcement dates were staggered by category — 503A first, 503B a few weeks later — because outsourcing facilities have manufactured…

This is exactly what I could not find anywhere else. Sending this to two other people who asked me the same thing last week.

15 13BiostatsBrad, PeptideSynthNJ, Dr.KarenChen and 12 others
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SleepFixSam
Member
212
678
Nov 2024
Hawaii
May 31, 2025 at 2:13 AM#13
Dr.LeslieOBGYN said:
I have been on both brand and compounded, and in the context of compounded supply, my experience has been equivalent with both.

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)
16 14raj_cambridge, ingrid_STO, pete_nash and 13 others
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Janoshik Analytical — Independent Testing

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lucas_SP_BR
Member
456
1,890
Jun 2024
São Paulo, BR
May 31, 2025 at 7:22 PM#14
lisa_labSD 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…

GMP compliance checklist relevant to compounded supply compounding quality:

  • Clean room environment with HEPA filtration
  • Environmental monitoring (viable and non-viable)
  • Personnel training and competency assessment
  • Validated analytical methods for testing
  • Stability testing program
  • Complete batch records and traceability
  • Quality management system with deviation handling

A 503B pharmacy following cGMP should be able to answer questions about ALL of these if you ask. Don't be afraid to ask — it's your health.

17 15KarenAZ_mom, zoe_NC, Dr.ObesityLA and 14 others
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mike_mod
Moderator
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Nov 2023
New York
Online
Jun 1, 2025 at 12:30 PM#15

Moderator note: leaving this open. It is being argued well and the disagreement is the useful part.

18 16PurityPaulOR, MaxMetOK, MounjBrad and 15 others
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