PEPTIDEREPORT

FDA · Rulemaking and policy

FDA proposes excluding semaglutide, tirzepatide, and liraglutide from the 503B Bulks List

FDA proposed excluding three GLP-1 active ingredients from the 503B Bulks List after preliminarily finding no clinical need for outsourcing facilities to compound them from bulk substances. The proposal is not a final determination.

Proposal legal stageApr 30, 2026 record dateUnited States jurisdiction
Open the primary-source record

Record status

Proposal; comment period closed

Agency
U.S. Food and Drug Administration
Action
Proposed 503B bulks-list decision
Stage
Proposal
Last verified
Jul 10, 2026

Source-backed timeline

Status history

  1. Proposal announcedSource

Editorial boundary: Peptide Report summarizes the public source and preserves its procedural stage. This page does not convert an allegation, proposal, advisory discussion, or warning into a final legal conclusion.

Back to all Regulatory Watch records