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ForumsCompounding & FormulationFDA March 2026 enforcement update — compounding pharmacies Page 2

FDA March 2026 enforcement update — compounding pharmacies

RegAffairsDC Fri, Dec 1, 2023 at 4:00 PM 275 replies 54,177 viewsPage 2 of 20
PharmD_Rodriguez
Senior Member
3,456
14,567
Jan 2024
Miami, FL
Dec 1, 2023 at 6:50 PM#6
Previously posted:
Your local compounding pharmacy making semaglutide in a back room is not the same as Novo Nordisk's billion-dollar manufacturing facility.

This is a straw man argument. Nobody is defending back-room operations. The well-run 503B outsourcing facilities have ISO-classified cleanrooms, validated HPLC testing, and FDA inspections. They're not mixing this stuff with a spoon in a closet.

And let's be real about the access issue — without compounding, millions of patients lose access to medications that are literally saving their lives. The brand manufacturers created a shortage they can't resolve. Compounding exists to fill that gap. That's the entire point of the 503 framework.

13 18paul_denver, TinaHashiRN, robert_kc and 10 others
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AttorneyGrant
Member
567
2,890
Apr 2024
Washington, DC
Dec 1, 2023 at 7:07 PM#7

For those wanting to track the legal cases, here are the key ones to watch:

  • Outsourcing Facilities Association v. FDA — 5th Circuit, oral arguments scheduled April 2026
  • Empower Rx v. FDA — challenging tirzepatide enforcement actions
  • Multiple state-level cases challenging FDA jurisdiction over 503A pharmacies

I'll update the thread as these develop. This is genuinely one of the most consequential pharma regulatory battles in years.

43 15laura_annarbor, JenMemphis, pat_auckland and 40 others
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AussieAnna
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678
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Jun 2024
Sydney, AU
Dec 1, 2023 at 7:24 PM#8

Thank you everyone. This is both reassuring and terrifying. I'm going to stock up on a few months supply just in case. Is that... legal? Can I get multiple prescriptions filled ahead? 😬

33 11LibrarianMeg, bri_stats, pete_manc_UK and 30 others
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Dr.GutHealth
Senior Member
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Mar 2024
Minnesota
Dec 1, 2023 at 7:41 PM#9

You can fill prescriptions as your doctor writes them — most compounding pharmacies allow 90-day supplies. But "stockpiling" beyond your prescribed amount isn't really possible since you need valid prescriptions. Talk to your doctor about continuity planning. That's the most productive thing you can do right now.

39 21Dr.RaviCardio, jennifer_SEA, tyler_CSCS and 36 others
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