Posting this as a warning rather than a discussion, and I will edit the post if any of it turns out to be wrong.
My pharmacy stopped supplying with three weeks notice and a letter that explained nothing, so I went and read the statute.
The enforcement dates were staggered by category — 503A first, 503B a few weeks later — because outsourcing facilities have manufactured inventory and clinic contracts to unwind while a 503A makes to order.
What to check: Two things anyone can check: a state licence number for a 503A, and an FDA outsourcing-facility registration for a 503B. Both are publicly searchable, and a pharmacy unwilling to give you either has answered the question.
If your experience contradicts this, say so in the thread — I would rather be corrected here than have people act on a warning that does not hold.
SarahChen_PharmD said:My pharmacy stopped supplying with three weeks notice and a letter that explained nothing, so I went and read the statute.
SarahChen_PharmD has the substance of this right. The condition it depends on is worth stating. 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.
SarahChen_PharmD said:My pharmacy stopped supplying with three weeks notice and a letter that explained nothing, so I went and read the statute.
Pushing back on SarahChen_PharmD 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.
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View ResultsShort answer first, then the reasoning. 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.
pete_manc_UK said:The shortage clause is the answer to the second question and it is a subtraction rather than an addition.
Adding a me-too, because a thread of one person's experience is not much use.