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ForumsPublic SquareFDA compounding enforcement update — June 2026 guidance document Page 2

FDA compounding enforcement update — June 2026 guidance document

RegAffairsDC Mon, Feb 26, 2024 at 4:00 PM 336 replies 53,782 viewsPage 2 of 20
TirzTom
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Feb 27, 2024 at 11:55 AM#6

Adding the numbers, since they settle part of this. 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.

6 1josh_phd_bmore, roxy_nash, tony_orlando and 3 others
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denise_HTX
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Feb 27, 2024 at 7:49 PM#7

A narrower follow-up, since the general answer is now clear:

Why a shortage listing created a legal pathway at all, since a shortage is a supply fact rather than a permission?

5 0NeuroNate, JessicaH_TX, KevinCompounds and 2 others
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Dr.LeslieOBGYN
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Feb 28, 2024 at 3:43 AM#8
TirzTom said:
Two things anyone can check: a state licence number for a 503A, and an FDA outsourcing-facility registration for a 503B.

There is a second half to this that has not been said yet. 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: Feb 28, 2024 at 9:43 AM
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RegAffairsDC
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Feb 28, 2024 at 11:37 AM#9

Closing the loop on my own question.

The bulks-list asymmetry was the piece I had missed entirely. It explains why one of my two pharmacies is still arguing it can supply and the other simply stopped.

3 23sean_dublin, hannah_MT, Dr.SportsMedIN
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MikeNYC_runner
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Mar 1, 2024 at 1:31 AM#10
Dr.LeslieOBGYN said:
Resolution therefore closed the doors unevenly, and the asymmetry follows from the bulks lists.

Agreed, and 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.

17 17MASHdoc_SA, GenomicsKate, Dr.ObesityMed and 14 others
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