Has anyone dealt with my pharmacy just stopped compounding sema - now what???

KevinCompounds said:

FDA inspection results for compounding pharmacies selling compounded supply: you can look up any 503B facility's FDA inspection history on the FDA…

Mine went the same way, slower.

KevinCompounds 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:

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)

KevinCompounds 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.

One thing that is still open after KevinCompounds’s answer:

What did you change at the same time, and can you separate the two now?

PeptideSynthNJ said:

GMP compliance checklist relevant to compounded supply compounding quality: Clean room environment with HEPA filtration Environmental monitoring…

Beyond-use dating (BUD) for compounded supply compounded products:

Lyophilized (unreconstituted): typically 9 months from compounding date
Reconstituted with BAC water: typically 28-30 days refrigerated
Reconstituted with sterile water: typically 7 days (no preservative!)

Always use BAC water for multi-dose vials. Sterile water has no preservative and supports bacterial growth after first puncture. This is a common and potentially dangerous mistake.