Compounded sema potency testing — HPLC method validation details

Dr.NateNeph said:

Regarding compounded supply compounding legality: compounding pharmacies can legally produce semaglutide and tirzepatide while these drugs remain on…

Thank you for spelling out the reasoning rather than just the conclusion. Adding it to my notes with a link back to this thread.

Adding the clinical framing, because it changes how the question reads.

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 3 inspections.

This is public information. Use it. Link: fda.gov/inspections-compliance-enforcement-and-criminal-investigations

Dr.LeslieOBGYN said:

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

Same experience, arrived at from the opposite direction.

Dr.LeslieOBGYN 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)

Dr.LeslieOBGYN 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.