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ForumsInternationalHas anyone dealt with eu ema compounding guidance? Page 3

Has anyone dealt with eu ema compounding guidance?

paul_denver Mon, Jan 20, 2025 at 9:06 AM 26 replies 1,812 viewsPage 3 of 6
DeniseRN_TPA
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Tampa, FL
Jan 26, 2025 at 9:59 AM#11
Dr.EndoEP said:
The shortage clause is the answer to the second question and it is a subtraction rather than an addition.

This answered a question I did not know how to ask. Sending this to two other people who asked me the same thing last week.

33 6jim_asheville, matt_MKE, Dr.ReproEndo and 30 others
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andrew_nyc
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Apr 2024
New York, NY
Jan 27, 2025 at 10:02 PM#12

From the other side of the consultation, briefly.

Compounding pharmacy response time test for compounded supply: I email customer service at odd hours to test responsiveness. A pharmacy that can't answer questions promptly is a red flag.

My current pharmacy: average response time same day. They answered my questions about sterility testing thoroughly and professionally.

Communication quality is a proxy for operational quality. A pharmacy that communicates well is likely manufacturing well too.

34 7Dr.NateNeph, PharmD_Rodriguez, julia.endo and 31 others
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BariatricNurseD
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Dallas, TX
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Jan 29, 2025 at 10:04 AM#13
claudia_zurich 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…

Vendor communication red flags for compounded supply:

  • Won't provide COA before purchase — walk away
  • Claims "100% pure" without analytical data — unrealistic
  • No physical address or phone number — accountability matters
  • Pushes you to buy more than you need — pressure tactics
  • Won't answer questions about their compounding process — transparency is key
  • Payment only via crypto or wire transfer — legitimate pharmacies accept cards

A legitimate compounding pharmacy operates like a healthcare business, not a gray market dealer.

35 8josh_phd_bmore, roxy_nash, tony_orlando and 32 others
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Dr.AddMedPHL
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Mar 2024
Philadelphia, PA
Jan 30, 2025 at 10:05 PM#14
paul_denver said:
They are two different exemptions from the same federal requirements and they buy different things.

Compounding pharmacy customer here with experience relevant to compounded supply.

I've ordered from 2 different compounding pharmacies over the past 2 years. The quality variation is real — purity ranged from 94% to 101% of label claim based on independent Janoshik testing.

My current compounder (a 503B facility) has been consistently 98-101% purity across 10 orders. I pay $133/month vs $1,363 for brand. The savings are substantial and the product is equivalent in my experience.

Re: compounded supply — this applies whether you're using brand or compounded. The clinical principles are the same.

36 9TomFromTexas, mike.trainer_LA, sarah_nash92 and 33 others
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Admin
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Feb 1, 2025 at 10:05 AM#15

Moderator note: the sourcing question belongs in the vendor section and has been split out.

37 10PeptideSynthNJ, Dr.KarenChen, Dr.NateNeph and 34 others
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