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ForumsCompounding & FormulationFDA June 2026 enforcement update — compounding pharmacies Page 4

FDA June 2026 enforcement update — compounding pharmacies

RegAffairsDC Mon, Feb 26, 2024 at 4:00 PM 366 replies 55,812 viewsPage 4 of 20
B12Beth
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Mar 9, 2024 at 5:52 AM#16
NurseKim_ATL said:
Vendor communication red flags for compounded supply: Won't provide COA before purchase — walk away Claims "100% pure" without analytical data —…

Same experience, arrived at from the opposite direction.

41 16GraceAZ_72, carl_compliance, DanielChem_CHI and 38 others
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KarenAZ_mom
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Scottsdale, AZ
Mar 11, 2024 at 2:20 AM#17
dan_philly said:
I have been on both brand and compounded, and in the context of compounded supply, my experience has been equivalent with both.

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.

Last edited: Mar 11, 2024 at 7:20 AM
40 15pete_manc_UK, anna.melb_AU, mark_tokyo and 37 others
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SurmountFan_IN
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Mar 12, 2024 at 10:47 PM#18
dan_philly said:
I have been on both brand and compounded, and in the context of compounded supply, my experience has been equivalent with both.

Saving this. It is the first explanation that did not require me to already understand it. Adding it to my notes with a link back to this thread.

39 14traveltech_sara, AttorneyGrant, DebRD_ATL and 36 others
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Dr.RheumBOS
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Mar 14, 2024 at 7:13 PM#19

From the other side of the consultation, briefly.

Compounded semaglutide formulations for compounded supply: some pharmacies add ingredients like B12, L-carnitine, or BPC-157 to their semaglutide preparations. Are these beneficial or marketing gimmicks?

My take: B12 addition has some logic (GLP-1s can deplete B12). L-carnitine evidence is weak. BPC-157 for GI protection is theoretically interesting but unproven. I prefer straight semaglutide with no additives — fewer variables, cleaner data on what's working.

38 13lori_vegas, Dr.PulmRoch, maya_sedona and 35 others
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mike_mod
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Mar 16, 2024 at 3:38 PM#20

Moderator note: good thread. Keeping it here rather than moving it, because the question is general enough to be useful. Carry on.

16 16PurityPaulOR, MaxMetOK, MounjBrad and 13 others
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