FDA proposed ruleupcoming
FDA 503B exclusion proposal for semaglutide + tirzepatide — public comment closes
Monday, August 3, 2026 · FDA
Public comment period closes on the May 4, 2026 FDA proposed rule excluding semaglutide and tirzepatide from the 503B Outsourcing Facility bulks list. After this, the FDA reviews comments and may issue a final rule.
Peptides affected
- Semaglutide
- Tirzepatide
- Wegovy
- Zepbound
- Ozempic
Sources & further reading
- Primary source · FDA fda proposed rule
- In-depth coverage · The FDA 503B GLP-1 compounding cliff: what changes, who's affected, what to do
Regulatory event entry on peptide regulatory calendar. Event details may change as the agency publishes updates — verify against the primary source above before acting on the timeline.