Record 01 Week of 5 October 2026 · REGULATION Six peptides recommended for the 503A bulks list · REGULATION From Category 2 to review: how twelve peptides came off the restricted list · REGULATION FDA proposes to end 503B compounding of semaglutide, tirzepatide and liraglutide · TRIALS Retatrutide: four Phase 3 readouts in 2026 · TRIALS Orforglipron approved; the oral GLP-1 question · PAPERS GLP-1 drugs recruit hunger neurons to sustain fat loss, Yale study finds · PAPERS A peptide–drug conjugate that hits five targets, in mice · PAPERS What GLP-1 users do differently: activity, bone and persistence · EVIDENCE BPC-157: what the human record contains · PUBLIC AND POLICY A public-health school explains the peptides in the feed · PUBLIC AND POLICY The gray market and the state patchwork · INDUSTRY Who makes peptides: capacity and ownership moves · Record 01 Week of 5 October 2026 · REGULATION Six peptides recommended for the 503A bulks list · REGULATION From Category 2 to review: how twelve peptides came off the restricted list · REGULATION FDA proposes to end 503B compounding of semaglutide, tirzepatide and liraglutide · TRIALS Retatrutide: four Phase 3 readouts in 2026 · TRIALS Orforglipron approved; the oral GLP-1 question · PAPERS GLP-1 drugs recruit hunger neurons to sustain fat loss, Yale study finds · PAPERS A peptide–drug conjugate that hits five targets, in mice · PAPERS What GLP-1 users do differently: activity, bone and persistence · EVIDENCE BPC-157: what the human record contains · PUBLIC AND POLICY A public-health school explains the peptides in the feed · PUBLIC AND POLICY The gray market and the state patchwork · INDUSTRY Who makes peptides: capacity and ownership moves ·

NEWS BRIEF REGULATION Regulation and policy

FDA proposes to end 503B compounding of semaglutide, tirzepatide and liraglutide

The agency's reasoning is that approved versions are available, so outsourcing facilities have no clinical need to compound from bulk.

Published 5 Oct 2026 Event 30 Apr 2026 Sources 3 REGULATORY · PROPOSALROUTE · 503B OUTSOURCINGSTATUS · PENDING

On 30 April 2026 the FDA proposed excluding semaglutide, tirzepatide and liraglutide from the list of bulk drug substances that 503B outsourcing facilities may compound from. The agency's position is that where an approved drug is available, facilities may not lawfully compound from bulk substance without a demonstrated clinical need. [1][2]

Reporting on the proposal cites more than 455 adverse-event reports tied to compounded semaglutide and more than 320 tied to compounded tirzepatide. [3]

The proposal runs in the opposite direction from the July advisory vote on unapproved peptides: one pathway is being narrowed for approved drugs with large trial programmes while another is being considered for compounds with little or no human trial data. [3]

SOURCES

FDA. FDA proposes to exclude semaglutide, tirzepatide, and liraglutide on 503B bulks list. 30 Apr 2026. Regulatory document.
Pharmacy Times. FDA moves to permanently close the door on compounded GLP-1s. 1 May 2026. News report. https://www.pharmacytimes.com/view/fda-moves-to-permanently-close-the-door-on-compounded-glp-1s
AJMC. Peptide regulation debate intensifies after FDA advisory panel's controversial vote. 25 Sep 2026. News feature. https://www.ajmc.com/view/peptide-regulation-debate-intensifies-after-fda-advisory-panel-s-controversial-vote

CHANGELOG · 5 Oct 2026 FIRST PUBLISHED · CORRECTIONS ARE ADDED HERE, NEVER HIDDEN