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FDA proposes excluding semaglutide, tirzepatide and liraglutide from 503B bulks list

If finalized, the May 1 proposal would close the last large-scale compounding pathway for the three GLP-1 receptor agonists at outsourcing facilities.

MH
By Maren Holt · Senior Reporter, GLP-1
May 13 03:00 ETSource: afslaw.com

The wire

  1. 01FDA announced on May 1 that it proposes to exclude semaglutide, tirzepatide and liraglutide from the 503B Bulks List, which covers substances the agency deems a clinical need.
  2. 02Compounded GLP-1s reportedly reached up to 30% of US supply at their 2024 peak per KFF; finalization would leave only patient-specific 503A compounding.
  3. 03Outsourcing Facilities Association lawsuits challenging the 2024 tirzepatide and 2025 semaglutide shortage resolutions are pending appeal before the Fifth Circuit.

From the source

The Shot Heard ‘Round the Pharmacy’: FDA Takes Aim at GLP-1 Compounders

On May 1, the US Food and Drug Administration ( FDA ) announced that it is proposing to exclude semaglutide, tirzepatide, and liraglutide from the 503B Bulks List. If finalized, this proposal would close the last remaining regulatory pathway for large-scale compounding of these popular GLP -1 receptor agonists by 503B outsourcing facilities.

Read at afslaw.com
Source URL https://www.afslaw.com/perspectives/longevity-lens/the-shot-heard-round-the-pharmacy-fda-takes-aim-glp-1-compounders