VendorMark said:Compounding pharmacy customer here with experience relevant to compounded supply.
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 still in shortage, tirzepatide removed from shortage list. This directly impacts compounding availability.
Dr.AddMedPHL said:Worth adding the genuine exception, because it is real and narrow: a change made for an identified patient where the prescriber determines it produces…
Thank you for spelling out the reasoning rather than just the conclusion. I will report back once I have actually tried it.
VendorMark said:Compounding pharmacy customer here with experience relevant to compounded supply.
Compounding pharmacy licensing verification for compounded supply: before ordering, verify your pharmacy's credentials:
- State Board of Pharmacy license — check on your state BOP website
- FDA registration (for 503B) — check on fda.gov
- DEA registration if handling controlled substances
- PCAB accreditation — voluntary but demonstrates commitment to quality
- USP <797>/<800> compliance for sterile compounding
This takes 10 minutes of research and could save you from receiving substandard or unsafe medication.
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Shop Reference StandardsKarenAZ_mom said:My pharmacy stopped supplying with three weeks notice and a letter that explained nothing, so I went and read the statute.
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
Moderator note: a couple of off-topic posts removed. Report rather than reply if it drifts again.