[REVIEW] Tailor Made Compounding — need advice

Short answer first, then the reasoning. 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.

Dr.RenalNash said:

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

That is correct as far as it goes, and here is where it stops going. 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.

denise_HTX said:

My pharmacy stopped supplying with three weeks notice and a letter that explained nothing, so I went and read the statute.

Same position here, arrived at the long way round. 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.

I would rather be corrected than agreed with, if it comes to it.

From the other side of the consultation, briefly.

Price comparison for compounded supply across sources I've used:

I use the 503B option — best balance of quality, cost, and legality. The brand price is insane but insurance can help if you qualify.