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ForumsInternationalHas anyone dealt with eu ema compounding guidance? Page 4

Has anyone dealt with eu ema compounding guidance?

paul_denver Mon, Jan 20, 2025 at 9:06 AM 26 replies 1,812 viewsPage 4 of 6
Dr.EM_Chicago
Member
567
2,567
May 2024
Chicago, IL
Feb 2, 2025 at 10:04 PM#16
carl_compliance said:
GMP compliance checklist relevant to compounded supply compounding quality: Clean room environment with HEPA filtration Environmental monitoring…

Adding a me-too, because a thread of one person's experience is not much use.

38 11jim_asheville, matt_MKE, Dr.ReproEndo and 35 others
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hannah_MT
New Member
23
89
Feb 2026
Bozeman, MT
Feb 4, 2025 at 10:03 AM#17
hank_denver said:
For compounded supply users considering compounded for the first time: here's a step-by-step guide: Get a prescription from your doctor (telehealth…

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.

39 12MounjBrad, nick_newbie, DadBodDave and 36 others
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FranDenver
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267
1,123
Oct 2024
Denver, CO
Feb 5, 2025 at 10:01 PM#18
hank_denver said:
For compounded supply users considering compounded for the first time: here's a step-by-step guide: Get a prescription from your doctor (telehealth…

Compounding pharmacy red flag checklist for compounded supply — if ANY of these apply, find a different source:

  1. No verifiable physical address
  2. No pharmacist available for consultation
  3. COA not available or clearly template/fake
  4. Prices dramatically below market ($30-40/month = suspicious)
  5. No prescription required
  6. Ships without cold pack or temperature control
  7. No batch/lot numbers on product labeling
  8. Pushes "research use only" products for human injection

Your health depends on product quality. Don't cut corners on source verification.

40 13BariatricNurseD, MASHdoc_SA, GenomicsKate and 37 others
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jason_sac26
New Member
34
123
Jan 2026
Sacramento, CA
Feb 7, 2025 at 9:58 AM#19
hank_denver said:
For compounded supply users considering compounded for the first time: here's a step-by-step guide: Get a prescription from your doctor (telehealth…

This is exactly what I could not find anywhere else. Sending this to two other people who asked me the same thing last week.

41 14maya_sedona, stefan_berlin, Dr.EM_Chicago and 38 others
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mike_mod
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Nov 2023
New York
Online
Feb 8, 2025 at 9:54 PM#20

Moderator note: two posts asking for a source have been merged into one. Please search the thread before asking again. No action needed from anybody.

13 11PurityPaulOR, MaxMetOK, MounjBrad and 10 others
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