Endotoxin testing in compounded injectables — looking for input

Dr.SurgeonPGH said:

503A vs 503B compounding pharmacies for compounded supply — this distinction matters enormously: Feature 503A 503B Regulation State Board of Pharmacy…

This matches mine closely enough to be worth saying so out loud.

dan_philly said:

Compounded semaglutide formulations for compounded supply: some pharmacies add ingredients like B12, L-carnitine, or BPC-157 to their semaglutide…

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.

One thing that is still open after dan_philly’s answer:

What did you change at the same time, and can you separate the two now?

Dr.AddMedPHL said:

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

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.

Moderator note: two posts asking for a source have been merged into one. Please search the thread before asking again.