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ForumsBuyer Beware⚠ Compounding pharmacies with FDA 483 observations — anyone have experience? Page 2

⚠ Compounding pharmacies with FDA 483 observations — anyone have experience?

alex_tucson Wed, Nov 12, 2025 at 6:01 PM 8 replies 933 viewsPage 2 of 2
gary_naperville
Member
245
1,123
Oct 2024
Naperville, IL
Nov 12, 2025 at 8:51 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. 😅

36 11SleepFixSam, PurityPaulOR, MaxMetOK and 33 others
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PharmacoVig_BOS
Senior Member
1,567
8,901
Feb 2024
Boston, MA
Nov 12, 2025 at 9:08 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. 🚩

6 15Dr.GutHealth, amsterdam_pete, LondonLisa and 3 others
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SarahChen_PharmD
VIP Member
4,567
22,341
Dec 2023
San Diego, CA
Nov 12, 2025 at 9:25 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. 👍

48 3paul_denver, TinaHashiRN, robert_kc and 45 others
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