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ForumsCompounding & FormulationHas anyone dealt with fda warning letters to compounding pharmacies? Page 2

Has anyone dealt with fda warning letters to compounding pharmacies?

DebRD_ATL Mon, Aug 5, 2024 at 2:36 AM 50 replies 2,916 viewsPage 2 of 10
sarah_TO
Member
278
1,234
Sep 2024
Toronto, CA
Aug 5, 2024 at 5:26 AM#6

This is incredibly helpful, thank you all. My doctor recommended a 503B facility called Empower. I looked them up and they're on the FDA registered list. Feeling much better about this now.

One more question — should I ask for the COA before or after filling the prescription? Is that a normal thing patients do? I don't want to come across as difficult. 😅

43 5andrew_nyc, Dr.EndoEP, GraceAZ_72 and 40 others
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NurseKim_ATL
Senior Member
1,678
7,234
Feb 2024
Atlanta, GA
Aug 5, 2024 at 5:43 AM#7

Ask after you receive it — the COA is batch-specific so you need your lot number first. And don't worry about being "difficult." Any pharmacy worth using will happily provide a COA. If they refuse or act weird about it, that's a red flag the size of Texas. 🚩

Last edited: Aug 5, 2024 at 10:43 AM
48 6raj_cambridge, ingrid_STO, pete_nash and 45 others
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nick_SD_fit
Member
278
1,234
Sep 2024
San Diego, CA
Aug 5, 2024 at 6:00 AM#8

Pinning this thread as it's one of the best 503A vs 503B breakdowns we've had. Thanks to our pharmacy and compounding experts for the detailed input.

Quick mod note: please don't post direct links to purchase from specific pharmacies. Discussion and naming is fine, but we can't have the forum become a storefront. Thanks all. 👍

42 15EndoResFellow, PharmacoVig_BOS, SurmountFan_IN and 39 others
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