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ForumsPublic SquareFDA compounding enforcement update — June 2026 guidance document Page 17

FDA compounding enforcement update — June 2026 guidance document

RegAffairsDC Mon, Feb 26, 2024 at 4:00 PM 336 replies 53,782 viewsPage 17 of 20
RegAffairsDC
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Mar 25, 2024 at 5:49 PM#81

OP back with an update, since a thread like this is useless without one.

Update — I was wrong in the opening post, specifically about the direction. Correcting it here rather than editing it away.

49 24amy_econ_NJ, bbq_ray_KC, oliver_london and 46 others
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hank_denver
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Mar 26, 2024 at 3:33 AM#82

One concrete data point for the thread. One practical note: write down what you did and when, before you need it. Reconstructing a timeline from memory three months later is how people end up unable to answer the one question that would have resolved it.

48 23raj_cambridge, ingrid_STO, pete_nash and 45 others
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nick_newbie
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Mar 26, 2024 at 1:17 PM#83

Following on from Dr.PathRoch — and this may be the naive question:

How long did you give it before you decided it was working?

47 22MeganSA_TX, LarryQC_SD, wanda_boise and 44 others
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PharmD_Rodriguez
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Mar 26, 2024 at 11:02 PM#84
hank_denver said:
One practical note: write down what you did and when, before you need it.

This is where I part company with the consensus forming above. Filing an objection on the n=1 problem. Personal experience is genuine evidence about one person and very weak evidence about anybody else, and this thread keeps promoting the first into the second.

46 21dan_philly, MeganSA_TX, LarryQC_SD and 43 others
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Dr.PulmRoch
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Mar 27, 2024 at 8:47 AM#85
hank_denver said:
One practical note: write down what you did and when, before you need it.

Fair, and it stops being fair at the extremes. The middle of the range is well understood; the ends are where the honest answer is that nobody knows.

Correct me if the detail matters more than I have assumed.

Last edited: Mar 27, 2024 at 9:47 AM
45 20KristenIndy, MarkLI_maint, Dr.PeteFamMed and 42 others
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