Has anyone dealt with eu ema compounding guidance?

hyun_seoul said:

The shortage clause is the answer to the second question and it is a subtraction rather than an addition.

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.

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

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.ReproEndo 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 customer here with experience relevant to compounded supply.

I've ordered from 4 different compounding pharmacies over the past 14 months. 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 8 orders. I pay $163/month vs $1,233 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.

paul_denver said:

They are two different exemptions from the same federal requirements and they buy different things.

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)

Moderator note: a couple of off-topic posts removed.