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ForumsBuyer BewareHow do I even know if my compounding pharmacy is legit — looking for input Page 2

How do I even know if my compounding pharmacy is legit — looking for input

lisa_labSD Mon, May 26, 2025 at 9:27 AM 14 replies 1,622 viewsPage 2 of 3
BethLabQueen
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May 27, 2025 at 12:25 AM#6
mike.trainer_LA said:
They are two different exemptions from the same federal requirements and they buy different things.

I read this differently from mike.trainer_LA, 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.

Last edited: May 27, 2025 at 1:25 AM
14 9maya_sedona, stefan_berlin, Dr.EM_Chicago and 11 others
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labquiet_amy
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May 27, 2025 at 6:21 AM#7
lisa_labSD said:
Two pharmacies quoted me last year, one describing itself as 503A and one as 503B, and I assumed 503B just meant bigger until both stopped within…

Regarding compounded supply compounding legality: compounding pharmacies can legally produce semaglutide and tirzepatide while these drugs remain on the FDA shortage list. If/when the shortage resolves, the legal landscape may change.

Stay informed. The FDA shortage list is updated regularly. Current status as of my last check: semaglutide still in shortage, tirzepatide removed from shortage list. This directly impacts compounding availability.

Last edited: May 27, 2025 at 8:21 AM
13 8HPLC_Greg, LibrarianMeg, bri_stats and 10 others
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BariatricNurseD
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May 27, 2025 at 12:17 PM#8
BethLabQueen 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.

12 7josh_phd_bmore, roxy_nash, tony_orlando and 9 others
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james_edin
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May 27, 2025 at 6:13 PM#9

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?

Last edited: May 27, 2025 at 8:13 PM
11 6oliver_london, tane_welly, Dr.PathRoch and 8 others
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lisa_labSD
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May 28, 2025 at 10:44 PM#10

OP back with an update, since a thread like this is useless without one.

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: May 29, 2025 at 1:44 AM
13 11cory_ATX, lori_vegas, Dr.PulmRoch and 10 others
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