Dr.NateNeph 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.
Dr.NateNeph said:FDA inspection results for compounding pharmacies selling compounded supply: you can look up any 503B facility's FDA inspection history on the FDA…
Thank you for spelling out the reasoning rather than just the conclusion. Taking it to my next appointment.
From the other side of the consultation, briefly.
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 $1,296 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.
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Shop Reference StandardsDr.PathRoch said:Compounding pharmacy customer here with experience relevant to compounded supply.
Mine went the same way, slower.
Dr.PathRoch said:Compounding pharmacy customer here with experience relevant to compounded supply.
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.