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ForumsBuyer BewareHow do I even know if my compounding pharmacy is legit — November 2025

How do I even know if my compounding pharmacy is legit — November 2025

VanRx_Mike Mon, Jul 22, 2024 at 6:25 PM 38 replies 2,586 viewsPage 1 of 8
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VanRx_Mike
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Vancouver, CA
Jul 22, 2024 at 6:25 PM#1

Two pharmacies quoted me last year, one describing itself as 503A and one as 503B, and I assumed 503B just meant bigger until both stopped within weeks of each other.

What I am after is why a shortage listing created a legal pathway at all, since a shortage is a supply fact rather than a permission.

Happy to be told the question itself is wrong.

3 23Dr.LeslieOBGYN, MikeNYC_runner
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DanielChem_CHI
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Jul 22, 2024 at 6:30 PM#2

Answering the narrow version, because the broad one does not have a single answer. 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.

Last edited: Jul 22, 2024 at 8:30 PM
2 22Dr.DermMIA, fiona_VT
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Dr.BariatricHTX
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Jul 22, 2024 at 6:35 PM#3
DanielChem_CHI said:
Resolution therefore closed the doors unevenly, and the asymmetry follows from the bulks lists.

DanielChem_CHI has the substance of this right. The condition it depends on is worth stating. 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.

Ask again with the specifics and you will get a better answer than this one.

1 21Dr.EM_Chicago
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pete_RVA
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Richmond, VA
Jul 22, 2024 at 6:40 PM#4
VanRx_Mike said:
Two pharmacies quoted me last year, one describing itself as 503A and one as 503B, and I assumed 503B just meant bigger until both stopped within…

This matches mine closely enough to be worth saying so. 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.

50 20MikeNYC_runner and 47 others
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Dr.EndoIndy
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Oct 2024
Indianapolis, IN
Jul 22, 2024 at 7:05 PM#5

From the other side of the consultation, briefly.

503A vs 503B compounding pharmacies for compounded supply — this distinction matters enormously:

Feature503A503B
RegulationState Board of PharmacyFDA-registered
PrescriptionRequired (patient-specific)Can compound without patient Rx
TestingVaries by statecGMP required
ScaleSmall batchesLarger production
Quality consistencyVariableGenerally higher

I strongly recommend 503B facilities. The FDA oversight and cGMP requirements mean more consistent product quality.

Last edited: Jul 22, 2024 at 10:05 PM
49 19SandraNC_45, Dr.EndoIndy, tom_AK and 46 others
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