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ForumsSemaglutide (Ozempic / Wegovy)Has anyone dealt with my compounded sema journey?

Has anyone dealt with my compounded sema journey?

Dr.PeteFamMed Wed, Jun 12, 2024 at 9:15 PM 11 replies 2,020 viewsPage 1 of 3
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Dr.PeteFamMed
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Jun 12, 2024 at 9:15 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.

The bit I cannot resolve on my own is 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.

19 14hyun_seoul, jim_asheville, matt_MKE and 16 others
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PeptideChemSF
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Jun 12, 2024 at 9:21 PM#2

Taking the question as asked, rather than the general version of it. 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.

Last edited: Jun 13, 2024 at 1:21 AM
18 13dave_SLC, FDA_TrackerJim, ricardo_MIA and 15 others
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josh_phd_bmore
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Jun 12, 2024 at 9:27 PM#3
PeptideChemSF said:
They are two different exemptions from the same federal requirements and they buy different things.

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.

17 12zoe_NC, Dr.ObesityLA, NurseKim_ATL and 14 others
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DadBodDave
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Jun 12, 2024 at 9:33 PM#4
Dr.PeteFamMed 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. 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: Jun 13, 2024 at 12:33 AM
16 11Dr.GastroMayo, JakeBK_lifts, DerekSJ_a1c and 13 others
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GenomicsKate
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Jun 12, 2024 at 10:03 PM#5

From the other side of the consultation, briefly.

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.

15 10claudia_zurich, nancy_portland, rick_sfbay and 12 others
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