FDA proposes to exclude semaglutide, tirzepatide and liraglutide from the 503B bulks list
The FDA proposed leaving semaglutide, tirzepatide and liraglutide off the 503B bulk drug substances list, finding no clinical need for outsourcing facilities to compound them from bulk now that the GLP-1 shortages are resolved. If finalized, the exclusion would close the last routine legal pathway for large-scale compounded GLP-1s and further narrow the supply of non-branded semaglutide and tirzepatide. The FDA took comments on the proposal through mid-2026 and is reviewing them; a final determination had not been published as of this writing.
Source
https://www.fda.gov/news-events/press-announcements/fda-proposes-exclude-semaglutide-tirzepatide-and-liraglutide-503b-bulks-listThe issuing body’s own page is authoritative. PepIndex records what it says and when we recorded it; where the two disagree, the source governs.
Compounds affected
Semaglutide
Read the evidence digest →
Tirzepatide
Read the evidence digest →
Liraglutide
Not in the PepIndex compound catalogue
Ranked vendors for Semaglutide
Every vendor and price for Semaglutide →- 1NLNorthline Labs$4.50/mg listed · 1 Semaglutide certificate90.2of 100Extensively documentedVisit Northline Labs
- 2
Amino Club$5.00/mg listed · 0 Semaglutide certificates90.1of 100Extensively documentedVisit Amino Club - 3
Ascend Science1 Semaglutide certificate88.9of 100Extensively documentedVisit Ascend Science
Ranked on this compound's price per mg against the market median, with testing and documentation counted as they are overall. A regulatory action against a vendor is recorded on that vendor's profile and counts against its score.
Ranked vendors for Tirzepatide
Every vendor and price for Tirzepatide →- 1
Origin Labs1 Tirzepatide certificate96.9of 100Extensively documentedVisit Origin Labs - 2
Next Gen Peptides$2.00/mg listed · 12 Tirzepatide certificates93.6of 100Extensively documentedVisit Next Gen Peptides - 3
Ascend Science$4.55/mg listed · 6 Tirzepatide certificates92.9of 100Extensively documentedVisit Ascend Science
Ranked on this compound's price per mg against the market median, with testing and documentation counted as they are overall. A regulatory action against a vendor is recorded on that vendor's profile and counts against its score.