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ForumsCompounding & FormulationHas anyone dealt with fda warning letters to compounding pharmacies? Page 10

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 10 of 10
LipidDoc_ATL
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Nov 10, 2024 at 11:35 PM#46

Clinical perspective, offered as context rather than as advice. Order of operations matters more than any single choice here: establish a baseline, change one thing, wait long enough for it to express itself, then measure again under the same conditions.

Last edited: Nov 11, 2024 at 4:35 AM
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DebRD_ATL
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Nov 11, 2024 at 6:28 AM#47

Closing the loop on my own question.

Reporting back for the archive rather than for the thread: I did the narrow version of what was suggested, gave it the full interval, and it settled. Posting it because threads without a follow-up are half a thread.

9 9RegAffairsDC, BiostatsBrad, PeptideSynthNJ and 6 others
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ZaraB_AL
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Nov 11, 2024 at 1:21 PM#48
LipidDoc_ATL said:
Order of operations matters more than any single choice here: establish a baseline, change one thing, wait long enough for it to express itself, then…

There is a second half to this that has not been said yet. Most of what circulates confidently in this community traces back to one summary of one study, and the qualifier was dropped somewhere in the third retelling.

Happy to go further on any of that.

Last edited: Nov 11, 2024 at 2:21 PM
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wendy_avl
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Oct 2024
Asheville, NC
Nov 11, 2024 at 8:14 PM#49

Adding the numbers, since they settle part of this. 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.

Last edited: Nov 12, 2024 at 2:14 AM
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bri_stats
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Nov 12, 2024 at 3:08 AM#50

One thing that is still open after LipidDoc_ATL’s answer:

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

35 10julia.endo, JessicaM_2024, TomFromTexas and 32 others
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