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ForumsCompounding & FormulationHas anyone dealt with is it normal for the powder to not fully dissolve?

Has anyone dealt with is it normal for the powder to not fully dissolve?

KarenAZ_mom Tue, Nov 18, 2025 at 4:29 PM 39 replies 1,964 viewsPage 1 of 8
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KarenAZ_mom
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Scottsdale, AZ
Nov 18, 2025 at 4:29 PM#1

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.

So the question, as narrowly as I can put it: what actually distinguishes 503A from 503B, in terms of what each may make and from what starting material.

If the honest answer is that nobody knows, that is a useful answer and I would rather have it.

30 0anna.melb_AU, mark_tokyo, hans_munich and 27 others
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PurityPaulOR
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Nov 18, 2025 at 4:52 PM#2

Short answer first, then the reasoning. 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: Nov 18, 2025 at 7:52 PM
29 24MikeNYC_runner and 26 others
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Dr.AddMedPHL
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Philadelphia, PA
Nov 18, 2025 at 5:15 PM#3
PurityPaulOR said:
Resolution therefore closed the doors unevenly, and the asymmetry follows from the bulks lists.

No disagreement with PurityPaulOR. 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.

Happy to go further on any of that.

28 23mike.trainer_LA, sarah_nash92, FitDadDave and 25 others
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AmyNC_wife
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North Carolina
Nov 18, 2025 at 5:38 PM#4
KarenAZ_mom said:
My pharmacy stopped supplying with three weeks notice and a letter that explained nothing, so I went and read the statute.

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.

27 22Dr.NateNeph, PharmD_Rodriguez, julia.endo and 24 others
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anna.melb_AU
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Melbourne, AU
Nov 18, 2025 at 7:42 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: Nov 18, 2025 at 11:42 PM
26 21Dr.LipidDallas, alex_tucson, kevin_tulsa and 23 others
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