paige_pharma said:Vendor communication red flags for compounded supply: Won't provide COA before purchase — walk away Claims "100% pure" without analytical data —…
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
One thing that is still open after paige_pharma’s answer:
How long did you give it before you decided it was working?
PharmacoVig_BOS 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 StandardsPharmacoVig_BOS said:FDA inspection results for compounding pharmacies selling compounded supply: you can look up any 503B facility's FDA inspection history on the FDA…
For compounded supply users considering compounded for the first time: here's a step-by-step guide:
- Get a prescription from your doctor (telehealth counts)
- Research 503B compounding pharmacies with good community reviews
- Verify their FDA registration and inspection history
- Request a COA for your specific compound before ordering
- Start with a 1-month supply to test
- Consider sending a sample to Janoshik for independent verification
- Track your response compared to brand (if you were on it previously)
Reporting back.
Closing this out. What actually changed my mind was the point about waiting for a trend instead of reading a single measurement, which is embarrassing in hindsight and worth saying anyway.