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ForumsPublic SquareFDA compounding enforcement update — March 2026 guidance document

FDA compounding enforcement update — March 2026 guidance document

RegAffairsDC Fri, Dec 1, 2023 at 4:00 PM 306 replies 13,484 viewsPage 1 of 20
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RegAffairsDC
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Dec 1, 2023 at 5:25 PM#1

FDA compounding enforcement update — March 2026 guidance document

Posting this as an important update for the public square community. Please read carefully as this may affect your current plans.

I will keep this thread updated as new information becomes available. If you have additional information or corrections, please post below and I will incorporate confirmed updates into this OP.

Key points:

  • This information is current as of the date posted
  • Circumstances may change — always verify independently
  • If you have questions, check if they have been answered in the replies before posting

Bookmarking this thread is recommended — it will be updated as the situation evolves.

— RegAffairsDC | Public Square
29 6amy_econ_NJ, bbq_ray_KC, oliver_london and 26 others
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LibrarianMeg
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Dec 1, 2023 at 5:42 PM#2

RegAffairsDC — wow. This community is amazing.

18 20PharmD_Rodriguez, julia.endo, JessicaM_2024 and 15 others
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TinaHashiRN
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Dec 1, 2023 at 5:59 PM#3

Thanks for sharing this, RegAffairsDC. A few questions about your FDA compounding experience:

  1. What dose did you start at?
  2. How long before you noticed side effects improving?
  3. Did your provider have any specific recommendations about FDA compounding?

I am in a similar boat and trying to learn from others' experiences before my next appointment.

Last edited: Dec 1, 2023 at 11:59 PM
50 0Dr.Martinez, mike_mod, SarahChen_PharmD and 47 others
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Dr.LipidDallas
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Dec 1, 2023 at 6:16 PM#4

Clinical perspective on FDA compounding enforcement update :

I have managed roughly 300 patients on GLP-1 therapy and this topic comes up frequently. What the data shows — and what I see in practice — is that the medication works best as part of a comprehensive approach.

For this specific question, I would recommend: getting comprehensive baseline labs first.

33 3lori_vegas, Dr.PulmRoch, maya_sedona and 30 others
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RegAffairsDC
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Dec 1, 2023 at 6:33 PM#5

OP here — wow, did not expect this much response! Thank you all for the thoughtful replies on FDA compounding.

To answer TinaHashiRN: yes, I am on compounded sema from a 503B pharmacy.

Quick update: things are still going well. Thanks again for the evidence-based discussion — this is exactly why I posted in a science-based community. 🙏

Last edited: Dec 1, 2023 at 8:33 PM
5 10gary_naperville, sean_dublin, hannah_MT and 2 others
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