SeqLine Bio · GLP-1 2026 update
Regulatory note · published 2026-06-05
On 2026-04-30 the FDA proposed removing semaglutide and tirzepatide from the bulk-substance framework used by US outsourcing facilities. This note summarizes the proposal as we read it and explains how SeqLine Bio supplies GLP-1 peptides to B2B research buyers.
The proposal concerns US outsourcing facilities that compound from bulk substances. SeqLine Bio supplies GLP-1 compounds as research peptides only. Buyers confirm the rules in their own market before import, resale or formulation work.
The proposal
This is not legal advice. Read the primary FDA documents and check with your counsel. This note reflects the proposal as published; check the federal docket for its current status.
The FDA proposed excluding semaglutide and tirzepatide, citing no continued need now that brand-name supply is no longer in shortage. If finalized, US outsourcing facilities could not compound these drugs from bulk substances unless they return to the FDA shortage list.
The public comment period on the federal docket ran through 2026-06-29.
The FDA declared the tirzepatide shortage over in December 2024 and the semaglutide shortage over in February 2025. The proposal follows from that status.
Who it affects
| US outsourcing facilities | Directly affected. If finalized, they face limits on compounding semaglutide and tirzepatide from bulk substances. |
|---|---|
| B2B research buyers | Review case by case. Keep research purchasing apart from any regulated finished-product route, and check local rules before importing, reselling or formulating. |
| Buyers outside the US | Not directly affected. Local regulators govern supply in each market. Semaglutide patents expire in 2026 in several countries, including India and China. |
| Non-GLP-1 peptides | Outside the proposal. The proposal names GLP-1 compounds only. |
SeqLine Bio
Tirzepatide, retatrutide and cagrilintide, supplied as research peptides to B2B buyers and for private-label evaluation. We confirm company details, destination and research use before quoting.
The rest of the catalog, from BPC-157 and TB-500 to GHK-Cu and NAD+, is supplied on the same terms: B2B, research use only, with a public COA for each published lot.
FAQ
To remove semaglutide and tirzepatide from the bulk-substance framework for US outsourcing facilities. Once final, those facilities could compound these drugs from bulk substance only if the drugs went back on the FDA shortage list. The comment period ran through 2026-06-29.
The proposal addresses a regulated compounding route. Research-use procurement and non-US markets need their own compliance review. Check the rules that apply to you before importing, reselling or formulating.
We supply GLP-1 peptides as research peptides for private-label evaluation, subject to each market's registration rules. Supply for therapeutic use is outside what we offer.
On fda.gov and the federal docket. Search for the bulk-substance proposal covering semaglutide and tirzepatide (2026).
Next step
We reply with what we can supply there, the price, lead time and the COA for the lot you would receive.
