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ForumsPublic SquareFDA compounding enforcement update — June 2026 guidance document Page 19

FDA compounding enforcement update — June 2026 guidance document

RegAffairsDC Mon, Feb 26, 2024 at 4:00 PM 336 replies 53,782 viewsPage 19 of 20
hank_denver
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Sep 2024
Denver, CO
Mar 29, 2024 at 7:26 PM#91

A narrower follow-up, since the general answer is now clear:

What did you change at the same time, and can you separate the two now?

18 18ingrid_STO, pete_nash, hank_denver and 15 others
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tane_welly
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234
1,123
Sep 2024
Wellington, NZ
Mar 30, 2024 at 5:18 AM#92

Found this through search years later and it is still the best discussion of the question, so adding one thing. The boring version of this is the one that works, and the boring version is: measure a baseline, change one variable, wait, measure again under the same conditions. Nobody wants that answer and it is still the answer.

17 17carl_compliance, DanielChem_CHI, marco_milano and 14 others
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HPLC_Greg
Senior Member
1,890
8,901
Feb 2024
Research Triangle, NC
Mar 30, 2024 at 3:10 PM#93
VendorMark said:
Practical: whatever you change, write down the date and the reason.

Agreed, with the usual condition: that holds for the average and this board is a collection of individuals. A population claim and a personal prediction are different things and get quoted interchangeably.

Last edited: Mar 30, 2024 at 9:10 PM
16 16RetaRick_CA, JenPlateau, SallyK_inj and 13 others
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DanielChem_CHI
Senior Member
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5,678
Mar 2024
Chicago, IL
Mar 31, 2024 at 2:02 AM#94
VendorMark said:
Practical: whatever you change, write down the date and the reason.

Saving this. It is the first explanation that did not require me to already understand it.

15 15ben_calgary, patPC_UT, Dr.DermMIA and 12 others
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hans_munich
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Jul 2024
Munich, DE
Mar 31, 2024 at 10:54 AM#95

Clinical perspective, offered as context rather than as advice. The honest answer is that the effect is real, the magnitude is contested, and the individual variation is larger than either. Those three things can all be true at once, and most arguments here are two people holding different parts of that.

14 14emma_london, tammy_FL, Dr.LipidDallas and 11 others
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