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 0 Form 483 observations in their last 4 inspections.
This is public information. Use it. Link: fda.gov/inspections-compliance-enforcement-and-criminal-investigations
Dr.RaviCardio said:FDA inspection results for compounding pharmacies selling compounded supply: you can look up any 503B facility's FDA inspection history on the FDA…
I have been on both brand and compounded, and in the context of compounded supply, my experience has been equivalent with both. The key is finding a reliable 503B pharmacy with independent testing.
Dr.RaviCardio said:FDA inspection results for compounding pharmacies selling compounded supply: you can look up any 503B facility's FDA inspection history on the FDA…
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.
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Shop Reference StandardsDr.RaviCardio said:FDA inspection results for compounding pharmacies selling compounded supply: you can look up any 503B facility's FDA inspection history on the FDA…
Saving this. It is the first explanation that did not require me to already understand it. Adding it to my notes with a link back to this thread.
Moderator note: good thread. Keeping it here rather than moving it, because the question is general enough to be useful. No action needed from anybody.