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ForumsCompounding & FormulationIs it normal for the powder to not fully dissolve — July 2024 Page 6

Is it normal for the powder to not fully dissolve — July 2024

PedsEndoPhilly Wed, Feb 7, 2024 at 3:59 PM 60 replies 3,510 viewsPage 6 of 12
james_edin
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Sep 2024
Edinburgh, UK
Feb 22, 2024 at 10:11 AM#26

From the other side of the consultation, briefly.

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

Last edited: Feb 22, 2024 at 12:11 PM
35 8mona_PHX, andrew_nyc, Dr.EndoEP and 32 others
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pete_RVA
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Dec 2024
Richmond, VA
Feb 23, 2024 at 10:02 PM#27
james_edin said:
FDA inspection results for compounding pharmacies selling compounded supply: you can look up any 503B facility's FDA inspection history on the FDA…

This is my experience too, for whatever a second data point is worth.

36 9Dr.Martinez, mike_mod, SarahChen_PharmD and 33 others
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Dr.BariatricHTX
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Feb 2024
Houston, TX
Feb 25, 2024 at 9:54 AM#28
james_edin said:
FDA inspection results for compounding pharmacies selling compounded supply: you can look up any 503B facility's FDA inspection history on the FDA…

Compounding pharmacy customer here with experience relevant to compounded supply.

I've ordered from 4 different compounding pharmacies over the past 14 months. The quality variation is real — purity ranged from 94% to 101% of label claim based on independent Janoshik testing.

My current compounder (a 503B facility) has been consistently 98-101% purity across 8 orders. I pay $131/month vs $1,381 for brand. The savings are substantial and the product is equivalent in my experience.

Re: compounded supply — this applies whether you're using brand or compounded. The clinical principles are the same.

Last edited: Feb 25, 2024 at 3:54 PM
37 10Dr.EM_Chicago, pete_RVA, CarlaRPh_TPA and 34 others
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PharmacoVig_BOS
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Feb 2024
Boston, MA
Feb 26, 2024 at 9:47 PM#29
james_edin said:
FDA inspection results for compounding pharmacies selling compounded supply: you can look up any 503B facility's FDA inspection history on the FDA…

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.

Last edited: Feb 27, 2024 at 12:47 AM
38 11kate.chem, DataDave, Dr.GutHealth and 35 others
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PedsEndoPhilly
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Philadelphia, PA
Feb 28, 2024 at 9:41 AM#30
Dr.BariatricHTX said:
Compounding pharmacy customer here with experience relevant to compounded supply.

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)
10 8MikeNYC_runner and 7 others
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