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ForumsPublic SquareFDA compounding enforcement update — March 2026 guidance document Page 2

FDA compounding enforcement update — March 2026 guidance document

RegAffairsDC Fri, Dec 1, 2023 at 4:00 PM 306 replies 13,484 viewsPage 2 of 20
Dr.EndoEP
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Dec 1, 2023 at 6:50 PM#6

Saving this for reference. Top-tier content.

24 12NicoleRaleigh, james_edin, FranDenver and 21 others
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Dr.PainCLE
Senior Member
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Mar 2024
Cleveland, OH
Dec 1, 2023 at 7:07 PM#7

Slightly tangential to FDA compounding but TinaHashiRN reminded me — what is the latest on the oral formulations?

I know it is not exactly on-topic but it seems related enough to ask here rather than starting a new thread. Apologies if this has been covered — I did search first.

Last edited: Dec 1, 2023 at 10:07 PM
26 5tane_welly, Dr.PathRoch, mona_PHX and 23 others
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gary_naperville
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Oct 2024
Naperville, IL
Dec 1, 2023 at 7:24 PM#8

+1 to TinaHashiRN. Especially the point about "A few questions about your FDA compoundi..." — I have seen the same in my own experience with FDA compounding.

18 16TomTeleRx, DoseLogDan, SleepFixSam and 15 others
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BrianDallas92
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Oct 2024
Dallas, TX
Dec 1, 2023 at 7:41 PM#9

Dr.LipidDallas — that is really helpful context on FDA compounding. Follow-up question: how long did you wait before increasing your dose?

I am in a similar situation (week 4) and trying to set realistic expectations.

36 20Dr.EndoEP, GraceAZ_72, carl_compliance and 33 others
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Dr.RenalNash
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Mar 2024
Nashville, TN
Dec 1, 2023 at 7:58 PM#10

To answer gary_naperville's question specifically:

From a clinical standpoint, FDA compounding enforcement is a reasonable concern that deserves a thorough answer.

The short answer: the evidence supports this approach for most patients.

The longer answer involves reviewing the specific clinical trial data relevant to your question, which I am happy to elaborate on if helpful.

16 19maria_elpaso, anders_CPH, Dr.NutriCornell and 13 others
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