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.

LabKate has the substance of this right. The condition it depends on is worth stating. They are two different exemptions from the same federal requirements and they buy different things. A 503A pharmacy is regulated primarily by the state board, needs a patient-specific prescription, is exempt from CGMP, and may use a bulk substance that has a USP monograph, is a component of an approved drug, or appears on the 503A bulks list — three independent doorways. A 503B outsourcing facility registers with the FDA, is inspected on a risk basis, must comply with CGMP, may compound for office stock without a patient-specific prescription, and has one doorway to a permitted bulk substance: the 503B bulks list, or the drug shortage list.

If somebody has the primary source to hand I would rather cite it than paraphrase it.

LabKate 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 LabKate, 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.

This one has a reasonably settled answer, so here it is. Resolution therefore closed the doors unevenly, and the asymmetry follows from the bulks lists. For 503B the shortage clause was the only route to these molecules, so that route shut completely. A 503A pharmacy can still argue a doorway via "component of an approved drug" — but only for the substance in the form present in the approved product, which is exactly where the base-versus-salt argument lives, and it does nothing about the copy restriction, which came back into force on resolution.

BenResearch_OR said:

They are two different exemptions from the same federal requirements and they buy different things.

Can confirm. Same sequence, different timescale.