Endotoxin testing in compounded injectables — LAL vs rFC methods

LabKate said:

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

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.

One thing that is still open after Dr.RenalNash’s answer:

Why a shortage listing created a legal pathway at all, since a shortage is a supply fact rather than a permission?

DanielChem_CHI said:

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

Compounding pharmacy licensing verification for compounded supply: before ordering, verify your pharmacy's credentials:

1. State Board of Pharmacy license — check on your state BOP website
2. FDA registration (for 503B) — check on fda.gov
3. DEA registration if handling controlled substances
4. PCAB accreditation — voluntary but demonstrates commitment to quality
5. USP <797>/<800> compliance for sterile compounding

This takes 10 minutes of research and could save you from receiving substandard or unsafe medication.

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.

Dr.EndoEP said:

Compounding pharmacy licensing verification for compounded supply: before ordering, verify your pharmacy's credentials: State Board of Pharmacy…

No disagreement with Dr.EndoEP. One condition attached. Worth adding the genuine exception, because it is real and narrow: a change made for an identified patient where the prescriber determines it produces a significant clinical difference for that patient. A grid of fixed doses offered to everybody is not that, whatever the intake form says.