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ForumsInternationalHas anyone dealt with eu ema compounding guidance? Page 5

Has anyone dealt with eu ema compounding guidance?

paul_denver Mon, Jan 20, 2025 at 9:06 AM 26 replies 1,812 viewsPage 5 of 6
MariaRD
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Jun 2024
New Mexico
Feb 10, 2025 at 9:33 AM#21

A narrower follow-up, since the general answer is now clear:

Did your prescriber agree with that reading, and if not what was their objection?

Last edited: Feb 10, 2025 at 10:33 AM
14 12Dr.NutriCornell, pam_stl, wei_SG and 11 others
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wanda_boise
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Aug 2024
Boise, ID
Feb 16, 2025 at 6:05 PM#22
tommy_boulder said:
Compounding pharmacy red flag checklist for compounded supply — if ANY of these apply, find a different source: No verifiable physical address No…

Compounded has been just as effective for me. If compounded supply is the concern, the COA from my 503B pharmacy shows 99.1% purity. Verified by Janoshik.

15 13marco_milano, pam_columbus, nick_SD_fit and 12 others
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labquiet_amy
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Mar 2024
Cambridge, MA
Feb 23, 2025 at 2:33 AM#23
tommy_boulder said:
Compounding pharmacy red flag checklist for compounded supply — if ANY of these apply, find a different source: No verifiable physical address No…

I have been on both brand and compounded, and in the context of compounded supply, my experience has been equivalent with both. The key is finding a reliable 503B pharmacy with independent testing.

16 14LibrarianMeg, bri_stats, pete_manc_UK and 13 others
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FitDadDave
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Jul 2024
Minneapolis, MN
Mar 1, 2025 at 10:57 AM#24
tommy_boulder said:
Compounding pharmacy red flag checklist for compounded supply — if ANY of these apply, find a different source: No verifiable physical address No…

That reframing is the part I needed. Adding it to my notes with a link back to this thread.

Last edited: Mar 1, 2025 at 1:57 PM
17 15wendy_avl, jason_paloalto, Dr.LeslieOBGYN and 14 others
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pete_nash
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Aug 2024
Nashville, TN
Mar 7, 2025 at 7:18 PM#25

From the other side of the consultation, briefly.

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.

18 16sarah.morrison, NeuroNate, JessicaH_TX and 15 others
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