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ForumsCrypto & PrivacyCryptocurrency payment adoption by compounding pharmacies — what worked for you?

Cryptocurrency payment adoption by compounding pharmacies — what worked for you?

robert_kc Thu, Feb 22, 2024 at 11:11 AM 16 replies 2,301 viewsPage 1 of 4
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robert_kc
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Feb 22, 2024 at 11:11 AM#1

My pharmacy stopped supplying with three weeks notice and a letter that explained nothing, so I went and read the statute.

The question I want answered is what actually distinguishes 503A from 503B, in terms of what each may make and from what starting material.

Not looking for reassurance. Looking for the part I have got wrong.

13 8PurityPaulOR, MaxMetOK, MounjBrad and 10 others
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Dr.ObesityMed
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Feb 22, 2024 at 11:38 AM#2

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

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SleepDoc_PDX
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Feb 22, 2024 at 12:05 PM#3
Dr.ObesityMed said:
The shortage clause is the answer to the second question and it is a subtraction rather than an addition.

Agreeing with Dr.ObesityMed, and the qualification matters more than the agreement. 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.

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PeptideMeter — Independent Peptide Analytics

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Dr.NephBHM_UK
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Feb 22, 2024 at 12:32 PM#4
robert_kc said:
My pharmacy stopped supplying with three weeks notice and a letter that explained nothing, so I went and read the statute.

Can confirm the pattern robert_kc describes. 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: Feb 22, 2024 at 6:32 PM
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SarahChen_PharmD
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Feb 22, 2024 at 3:00 PM#5

From the other side of the consultation, briefly.

Price comparison for compounded supply across sources I've used:

SourceMonthly CostTypePurity Verified
Brand (Ozempic)$1022FDA-approvedN/A (pharma)
503B Compounding$152cGMP compoundedYes (in-house)
503A Compounding$92Patient-specificVaries
Research peptide$62Not for human useOften Janoshik

I use the 503B option — best balance of quality, cost, and legality. The brand price is insane but insurance can help if you qualify.

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