My pharmacy stopped supplying with three weeks notice and a letter that explained nothing, so I went and read the statute.
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.
What would genuinely help is knowing what actually distinguishes 503A from 503B, in terms of what each may make and from what starting material.
Practical detail welcome, however dull — the duller the better.
Taking the question as asked, rather than the general version of it. 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.
If somebody has the primary source to hand I would rather cite it than paraphrase it.
julia.endo said:The shortage clause is the answer to the second question and it is a subtraction rather than an addition.
No disagreement with julia.endo. One condition attached. 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.
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View Resultscarl_compliance said:My pharmacy stopped supplying with three weeks notice and a letter that explained nothing, so I went and read the statute.
Can confirm the pattern carl_compliance describes. 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.
Adding the clinical framing, because it changes how the question reads.
Compounded has been just as effective for me. If compounded supply is the concern, the COA from my 503B pharmacy shows 99.1% purity. Verified by Janoshik.