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ForumsCompounding & FormulationHas anyone dealt with fda warning letters to compounding pharmacies? Page 7

Has anyone dealt with fda warning letters to compounding pharmacies?

DebRD_ATL Thu, Oct 31, 2024 at 2:36 AM 50 replies 2,916 viewsPage 7 of 10
amsterdam_pete
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Nov 6, 2024 at 5:09 PM#31

Following on from PharmD_Rodriguez — and this may be the naive question:

Did your prescriber agree with that reading, and if not what was their objection?

46 21JakeSmashed95, NauseaFreeNow, SteveThurs and 43 others
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AttorneyGrant
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Nov 6, 2024 at 11:56 PM#32
DebRD_ATL said:
Nothing dramatic to report, which is the report.

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.

45 20laura_annarbor, JenMemphis, pat_auckland and 42 others
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DataDave
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Nov 7, 2024 at 6:43 AM#33
DebRD_ATL said:
Nothing dramatic to report, which is the report.

Correct as far as it goes. The part it does not cover is what to do when the honest answer is "not enough data", which is more often than anyone likes.

Last edited: Nov 7, 2024 at 7:43 AM
44 19LondonLisa, mike_nyc, VendorMark and 41 others
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josh_phd_bmore
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Nov 7, 2024 at 1:31 PM#34
DebRD_ATL said:
Nothing dramatic to report, which is the report.

That reframing is the part I needed. Adding it to my notes with a link back to this thread.

Last edited: Nov 7, 2024 at 3:31 PM
43 18KarenAZ_mom, zoe_NC, Dr.ObesityLA and 40 others
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Dr.AddMedPHL
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Nov 7, 2024 at 8:19 PM#35

From the other side of the consultation, briefly. It helps to say which part of this you are uncertain about. A precise question gets a precise answer; a general one gets everybody’s favourite anecdote.

Last edited: Nov 7, 2024 at 10:19 PM
42 17JessicaM_2024, TomFromTexas, mike.trainer_LA and 39 others
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