USP <797> 2023 revision impact on peptide compounding — July 2024

From the other side of the consultation, briefly.

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 shortage ongoing, tirzepatide partially resolved. This directly impacts compounding availability.

paige_pharma said:

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

Mine went the same way, slower. I had assumed I was the exception until I read this.

paige_pharma said:

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

Compounded semaglutide formulations for compounded supply: some pharmacies add ingredients like B12, L-carnitine, or BPC-157 to their semaglutide preparations. Are these beneficial or marketing gimmicks?

My take: B12 addition has some logic (GLP-1s can deplete B12). L-carnitine evidence is weak. BPC-157 for GI protection is theoretically interesting but unproven. I prefer straight semaglutide with no additives — fewer variables, cleaner data on what's working.

paige_pharma said:

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

Beyond-use dating (BUD) for compounded supply compounded products:

Lyophilized (unreconstituted): typically 9 months from compounding date
Reconstituted with BAC water: typically 28-30 days refrigerated
Reconstituted with sterile water: typically 7 days (no preservative!)

Always use BAC water for multi-dose vials. Sterile water has no preservative and supports bacterial growth after first puncture. This is a common and potentially dangerous mistake.

Moderator note: two posts asking for a source have been merged into one. Please search the thread before asking again. No action needed from anybody.