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ForumsPublic SquareFDA compounding enforcement update — June 2026 guidance document Page 4

FDA compounding enforcement update — June 2026 guidance document

RegAffairsDC Mon, Feb 26, 2024 at 4:00 PM 336 replies 53,782 viewsPage 4 of 20
B12Beth
Member
289
890
Oct 2024
Maryland
Mar 1, 2024 at 6:37 PM#16
Dr.Martinez said:
Vendor communication red flags for compounded supply: Won't provide COA before purchase — walk away Claims "100% pure" without analytical data —…

Same experience, arrived at from the opposite direction. Posting only so the count is not one.

11 11GraceAZ_72, carl_compliance, DanielChem_CHI and 8 others
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fiona_VT
Member
178
890
Dec 2024
Vermont
Mar 1, 2024 at 9:28 PM#17
labquiet_amy said:
Compounding pharmacy response time test for compounded supply: I email customer service at odd hours to test responsiveness.

Saving this. It is the first explanation that did not require me to already understand it. Printing the relevant bit and taking it with me.

10 10hans_munich, jason_sac26, chris_chi24 and 7 others
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hyun_seoul
Member
345
1,456
Jul 2024
Seoul, KR
Mar 2, 2024 at 12:19 AM#18

Adding the clinical framing, because it changes how the question reads.

Compounding pharmacy customer here with experience relevant to compounded supply.

I've ordered from 5 different compounding pharmacies over the past 18 months. 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 5 orders. I pay $132/month vs $1,242 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.

9 9MASHdoc_SA, GenomicsKate, Dr.ObesityMed and 6 others
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TinaHashiRN
Member
345
1,567
Sep 2024
Raleigh, NC
Mar 2, 2024 at 3:10 AM#19
hyun_seoul said:
Compounding pharmacy customer here with experience relevant to compounded supply.

Can confirm. Same sequence, different timescale. I had assumed I was the exception until I read this.

8 8Admin, Dr.Martinez, mike_mod and 5 others
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mike_mod
Moderator
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19,823
Nov 2023
New York
Online
Mar 2, 2024 at 6:01 AM#20

Moderator note: a post naming a supplier has been edited. Discuss suppliers in the review sections, not here. No action needed from anybody.

36 11PurityPaulOR, MaxMetOK, MounjBrad and 33 others
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