Endotoxin testing in compounded injectables — looking for input

One thing that is still open after Dr.SurgeonPGH’s answer:

Was that from a primary source or from a summary of one?

PeptideSynthNJ said:

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

Compounding pharmacy red flag checklist for compounded supply — if ANY of these apply, find a different source:

1. No verifiable physical address
2. No pharmacist available for consultation
3. COA not available or clearly template/fake
4. Prices dramatically below market ($30-40/month = suspicious)
5. No prescription required
6. Ships without cold pack or temperature control
7. No batch/lot numbers on product labeling
8. Pushes "research use only" products for human injection

Your health depends on product quality. Don't cut corners on source verification.

PeptideSynthNJ 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)

PeptideSynthNJ 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 — that is the clearest version of this I have read, and I have read a lot of them. Printing the relevant bit and taking it with me.

hank_denver said:

For compounded supply users considering compounded for the first time: here's a step-by-step guide: Get a prescription from your doctor (telehealth…

Compounding pharmacy licensing verification for compounded supply: before ordering, verify your pharmacy's credentials:

1. State Board of Pharmacy license — check on your state BOP website
2. FDA registration (for 503B) — check on fda.gov
3. DEA registration if handling controlled substances
4. PCAB accreditation — voluntary but demonstrates commitment to quality
5. USP <797>/<800> compliance for sterile compounding

This takes 10 minutes of research and could save you from receiving substandard or unsafe medication.