⚠ Compounding pharmacies with FDA 483 observations — what worked for you?

LipidDoc_ATL said:

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

Agreeing with LipidDoc_ATL, and the qualification matters more than the agreement. 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.

LipidDoc_ATL said:

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

Pushing back on LipidDoc_ATL here. 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.

Taking the question as asked, rather than the general version of it. 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.

Dr.SportsMedIN said:

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

Adding a me-too, because a thread of one person's experience is not much use. Nothing to add that would improve it.