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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
VanRx_Mike
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Mar 29, 2024 at 7:26 PM#91
CarlaRPh_TPA said:
It is worth asking what the claim would look like if it were false.

Can confirm. Same sequence, different timescale.

18 18Dr.LeslieOBGYN, MikeNYC_runner and 15 others
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Dr.BariatricHTX
Senior Member
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Feb 2024
Houston, TX
Mar 30, 2024 at 5:18 AM#92
CarlaRPh_TPA said:
It is worth asking what the claim would look like if it were false.

There is a second half to this that has not been said yet. Start from the measurement rather than the conclusion. Almost every disagreement here turns out to be two people measuring different things and comparing the numbers anyway.

Last edited: Mar 30, 2024 at 11:18 AM
17 17pete_RVA, CarlaRPh_TPA, steph_laguna and 14 others
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PharmacoVig_BOS
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Feb 2024
Boston, MA
Mar 30, 2024 at 3:10 PM#93

One concrete data point for the thread. Practical: whatever you change, write down the date and the reason. In three months the reason is what you will have forgotten, and the reason is what makes the record worth having.

Last edited: Mar 30, 2024 at 6:10 PM
16 16DataDave, Dr.GutHealth, amsterdam_pete and 13 others
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tommy_boulder
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Nov 2024
Boulder, CO
Mar 31, 2024 at 2:02 AM#94

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?

15 15dan_philly, MeganSA_TX, LarryQC_SD and 12 others
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BiostatsBrad
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Jul 2024
Durham, NC
Mar 31, 2024 at 10:54 AM#95
PharmacoVig_BOS said:
Practical: whatever you change, write down the date and the reason.

This is where I part company with the consensus forming above. Pushing back on the anecdote-stacking. Twenty people reporting the same thing is twenty samples from the same self-selected pool, not twenty independent confirmations.

14 14NicoleRaleigh, james_edin, FranDenver and 11 others
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