VendorMark said:The shortage clause is the answer to the second question and it is a subtraction rather than an addition.
I read this differently from VendorMark, on substance rather than tone. A research-chemical supplier selling lyophilised powder labelled research use only is not compounding and is not claiming to. It is a different legal universe with no pharmacy oversight, no patient relationship and no content guarantee, and conflating the two in these threads helps nobody.
fiona_glasgow said:Two pharmacies quoted me last year, one describing itself as 503A and one as 503B, and I assumed 503B just meant bigger until both stopped within…
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)
anders_CPH said:A research-chemical supplier selling lyophilised powder labelled research use only is not compounding and is not claiming to.
Regarding compounded supply compounding legality: compounding pharmacies can legally produce semaglutide and tirzepatide while these drugs remain on the FDA shortage list. If/when the shortage resolves, the legal landscape may change.
Stay informed. The FDA shortage list is updated regularly. Current status as of my last check: semaglutide partially resolved shortage, tirzepatide still in shortage. This directly impacts compounding availability.
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Shop Reference StandardsFollowing on from robert_kc — and this may be the naive question:
What actually distinguishes 503A from 503B, in terms of what each may make and from what starting material?
Closing the loop on my own question.
The bulks-list asymmetry was the piece I had missed entirely. It explains why one of my two pharmacies is still arguing it can supply and the other simply stopped.