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ForumsCompounding & FormulationFDA June 2026 enforcement update — compounding pharmacies Page 2

FDA June 2026 enforcement update — compounding pharmacies

RegAffairsDC Mon, Feb 26, 2024 at 4:00 PM 366 replies 55,812 viewsPage 2 of 20
HealthEcon_DC
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Feb 26, 2024 at 6:40 PM#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. 😅

Last edited: Feb 26, 2024 at 8:40 PM
36 6NeuroNate, JessicaH_TX, KevinCompounds and 33 others
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NauseaFreeNow
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Indiana
Feb 26, 2024 at 7:42 PM#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: Feb 26, 2024 at 11:42 PM
35 5maya_sedona, stefan_berlin, Dr.EM_Chicago and 32 others
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Admin
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Feb 26, 2024 at 8:44 PM#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. 👍

Last edited: Feb 27, 2024 at 12:44 AM
34 4RegAffairsDC, BiostatsBrad, PeptideSynthNJ and 31 others
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