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ForumsCompounding & FormulationHas anyone dealt with compounding pharmacy clean room standards? Page 5

Has anyone dealt with compounding pharmacy clean room standards?

JakeSmashed95 Sat, Apr 26, 2025 at 10:17 AM 23 replies 1,672 viewsPage 5 of 5
nick_SD_fit
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Sep 2024
San Diego, CA
May 3, 2025 at 9:39 PM#21

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

How would you tell the difference between that and the alternative explanation?

Last edited: May 3, 2025 at 11:39 PM
4 4SkepticalSean, Dr.CardioMD, EndoResFellow and 1 other
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JennaRN
Senior Member
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Mar 2024
Colorado
Online
May 5, 2025 at 6:42 PM#22
ingrid_STO 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 response time test for compounded supply: I email customer service at odd hours to test responsiveness. A pharmacy that can't answer questions promptly is a red flag.

My current pharmacy: average response time 4 hours. They answered my questions about reconstitution thoroughly and professionally.

Communication quality is a proxy for operational quality. A pharmacy that communicates well is likely manufacturing well too.

3 3PeptideSynthNJ, Dr.KarenChen, Dr.NateNeph
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KetoKyle
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Jul 2024
Utah
May 7, 2025 at 3:44 PM#23
ingrid_STO 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 3 different compounding pharmacies over the past year. 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 6 orders. I pay $146/month vs $1,236 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.

2 2pat_auckland, Dr.GastroMayo
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amy_econ_NJ
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May 2024
Princeton, NJ
May 9, 2025 at 12:45 PM#24
ingrid_STO said:
FDA inspection results for compounding pharmacies selling compounded supply: you can look up any 503B facility's FDA inspection history on the FDA…

Bookmarking. The distinction being drawn above is the one nobody else makes. Printing the relevant bit and taking it with me.

1 1gary_naperville
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PharmHunterJen
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Jul 2024
Illinois
May 11, 2025 at 9:44 AM#25

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.

50 0mike_mealprep, NicoleRaleigh, james_edin and 47 others
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