Compounded sema potency testing — HPLC method validation details

HPLC_Greg said:

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

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

HPLC_Greg said:

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

I read this differently from HPLC_Greg, 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.

That is the short version; the long version is somebody else's post.

Answering the narrow version, because the broad one does not have a single answer. The shortage clause is the answer to the second question and it is a subtraction rather than an addition. Both exemptions forbid compounding something that is essentially a copy of a commercially available approved product. A product FDA has listed as in shortage is not treated as commercially available, so listing removed the objection that otherwise blocked compounding. It never created a permission; it withdrew a prohibition, which is why it evaporated the moment the supply fact changed.

DataDave said:

Resolution therefore closed the doors unevenly, and the asymmetry follows from the bulks lists.

This matches mine closely enough to be worth saying so. One addition: an unstated method makes a report close to uninterpretable. "99% pure" without the technique, the standard and the conditions is a claim, not a measurement.