FDA opens comment period on keeping semaglutide, tirzepatide and liraglutide off 503B list

The FDA published a notice in the Federal Register on May 1, 2026 that proposes leaving semaglutide, tirzepatide and liraglutide off the list of bulk drug substances that may be used to compound drugs under section 503B of the Federal Food, Drug, and Cosmetic Act ^[1]. The notice is cited as 91 FR 23431 and opens a formal comment period on that proposal ^[1].

The document runs 14 pages, from page 23431 to page 23444, in docket No. FDA-2018-N-3240, with document number 2026-08552 ^[1]. Written or electronic comments were due by June 30, 2026 under the notice's dates section ^[1]. A later notice published June 26, 2026 extends the comment period; the new closing date does not appear in the docket listing for that extension ^[1].

FDA organized the notice substance by substance under a heading titled "Substances Evaluated and Not Proposed for Inclusion on the 503B Bulks List" ^[1]. For semaglutide — the molecule sold as Ozempic, Wegovy and Rybelsus — the sections address the suitability of FDA-approved drug products, injectable products, oral products, "oral sublingual" and buccal products, multi-ingredient products, proposals for formulations without certain excipients, and whether the drug product must be compounded from a bulk drug substance ^[1].

For tirzepatide, sold as Mounjaro and Zepbound, the sections cover the suitability of FDA-approved products, oral, "oral sublingual" and buccal products, injectable products, multi-ingredient products, other issues, and whether the drug product must be compounded from a bulk drug substance ^[1]. For liraglutide, the sections address the suitability of FDA-approved products, whether the drug must be compounded from a bulk substance, and docket comments ^[1].

The notice is one of 12 documents in the same docket. The Federal Register lists earlier notices in that docket from 2020, 2021, 2022 and 2023, including one published Aug. 21, 2023 ^[1]. None of the items listed for the docket is identified as a final rule or a completed list ^[1].

Why it matters for patients

The notice concerns which bulk drug substances FDA considers to have a clinical need under section 503B, the pathway used by large outsourcing facilities ^[1]. Three of the most widely compounded GLP-1 molecules are named in it, and the categories FDA examines include injectables, oral drops and tablets, sublingual and buccal products, and combinations with other ingredients ^[1]. People who get semaglutide or tirzepatide from a 503B outsourcing facility rather than from an FDA-approved brand product are the group most directly affected by how the agency resolves the question.

The notice is a proposal, not a final decision. FDA describes each substance as "evaluated and not proposed for inclusion," meaning the agency has put forward a position and is accepting comments before anything is settled ^[1]. The document itself does not change the status of any substance on the day it was published ^[1].

It is not yet known when FDA will finalize its position, whether any of the three substances could still be added to the list, or what the extended comment deadline is ^[1]. The notice does not state a date for a final decision ^[1].

What happens next

• Comments on the May 1, 2026 notice were due June 30, 2026, and a notice published June 26, 2026 extended that period ^[1]. The new date has not been disclosed in the docket listing ^[1].
• Further documents in the matter will appear in docket No. FDA-2018-N-3240 ^[1].
• FDA has not announced a timeline for issuing a final decision on the three substances ^[1].