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ForumsCompounding & FormulationHow do you guys store your vials when traveling — need advice

How do you guys store your vials when traveling — need advice

SkepticalSean Thu, Mar 7, 2024 at 1:12 PM 17 replies 2,120 viewsPage 1 of 4
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SkepticalSean
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Mar 7, 2024 at 1:12 PM#1

Collecting this in one place because it comes up every few weeks and the answer is always assembled from scratch. It is about compounded supply, and it is deliberately narrow — everything I am not confident about is marked as such.

What is actually established

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.

The condition it depends on

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.

The practical version

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 I am not sure about

What I actually want to know 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.

— SkepticalSean · corrections welcome and will be edited into this post with credit
34 12DerekSJ_a1c, paige_pharma, emma_london and 31 others
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NurseKim_ATL
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Mar 7, 2024 at 2:39 PM#2
SkepticalSean said:
Resolution therefore closed the doors unevenly, and the asymmetry follows from the bulks lists.

No disagreement with SkepticalSean. One condition attached. 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.

35 13raj_cambridge, ingrid_STO, pete_nash and 32 others
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TrialTracker_MD
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Mar 7, 2024 at 4:05 PM#3
SkepticalSean said:
Resolution therefore closed the doors unevenly, and the asymmetry follows from the bulks lists.

I read this differently from SkepticalSean, on substance rather than tone. A research-chemical supplier selling lyophilised powder labelled research use only is not compounding and is not claiming to. It is a different legal universe with no pharmacy oversight, no patient relationship and no content guarantee, and conflating the two in these threads helps nobody.

Correct me if the detail matters more than I have assumed.

36 14maya_sedona, stefan_berlin, Dr.EM_Chicago and 33 others
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Dr.SleepRoch
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Mar 7, 2024 at 5:31 PM#4

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.

37 15tony_orlando, Dr.NephBHM_UK, kim_atl_prep and 34 others
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alex_tucson
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Mar 8, 2024 at 1:54 AM#5
NurseKim_ATL said:
The shortage clause is the answer to the second question and it is a subtraction rather than an addition.

Adding a me-too, because a thread of one person's experience is not much use.

38 16FDA_TrackerJim, ricardo_MIA, BrianDallas92 and 35 others
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