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ForumsCompounding & FormulationBeyond-use dating: 28 days vs 60 days — anyone have experience? Page 2

Beyond-use dating: 28 days vs 60 days — anyone have experience?

AussieAnna Thu, Apr 18, 2024 at 10:37 PM 7 replies 2,013 viewsPage 2 of 2
CarlaRPh_TPA
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Tampa, FL
Apr 19, 2024 at 7:17 AM#6
PharmD_Rodriguez said:
They are two different exemptions from the same federal requirements and they buy different things.

This is where I part company with the consensus forming above. 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.

5 8FDA_TrackerJim, ricardo_MIA, BrianDallas92 and 2 others
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PeptideChemSF
Senior Member
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Jan 2024
San Francisco, CA
Apr 19, 2024 at 10:41 AM#7
AussieAnna said:
My pharmacy stopped supplying with three weeks notice and a letter that explained nothing, so I went and read the statute.

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

SourceMonthly CostTypePurity Verified
Brand (Ozempic)$982FDA-approvedN/A (pharma)
503B Compounding$162cGMP compoundedYes (in-house)
503A Compounding$92Patient-specificVaries
Research peptide$47Not 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.

6 9dave_SLC, FDA_TrackerJim, ricardo_MIA and 3 others
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Dr.PeteFamMed
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Minneapolis, MN
Apr 19, 2024 at 2:05 PM#8
CarlaRPh_TPA said:
A research-chemical supplier selling lyophilised powder labelled research use only is not compounding and is not claiming to.

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.

7 10LindaRN_retired, tommy_boulder, hyun_seoul and 4 others
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sophie_paris
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Paris, FR
Apr 19, 2024 at 5:29 PM#9

One thing that is still open after Dr.GutHealth’s answer:

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

8 11AussieAnna, BethLabQueen, ChrisMacros and 5 others
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AussieAnna
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Sydney, AU
Apr 20, 2024 at 9:49 AM#10

Reporting back.

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.

Last edited: Apr 20, 2024 at 10:49 AM
38 11pete_manc_UK, anna.melb_AU, mark_tokyo and 35 others
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