# FDA proposes keeping GLP-1s off the 503B bulks list

> A May 1, 2026 FDA notice proposes leaving semaglutide, tirzepatide and liraglutide off the 503B bulks list. Comments closed July 30, 2026.

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- Last updated: October 26, 2026
- Publisher: Living+

Published October 26, 2026.

On May 1, 2026, FDA published a notice proposing not to put [semaglutide](/peptides/semaglutide/), [tirzepatide](/peptides/tirzepatide/) or [liraglutide](/peptides/liraglutide/) on the 503B Bulks List [1]. That list names the bulk ingredients that outsourcing facilities, the large compounders regulated under section 503B, may use because there is a clinical need for them [1]. FDA says other nominated substances are still under review and may appear in later notices [1].

## FDA's reasoning

FDA asked whether anything about the approved GLP-1 products makes them medically unsuitable for some patients, so that a compounded version would be needed [1]. For each of the three, FDA tentatively found no basis to conclude that [1]. FDA also said it did not count convenience or the cost of a compounded drug compared with an approved one when judging clinical need [1].

## Comment period

The notice first set a comment deadline of June 30, 2026 [1]. A June 26, 2026 notice extended it to July 30, 2026, after FDA received a request for more time [2]. The docket is FDA-2018-N-3240 [2]. A proposal is not a final decision; FDA would announce its final determination in a later notice [1].

## Where shortages fit

Outsourcing facilities may also compound from a bulk ingredient when the drug is on FDA's shortage list [1]. FDA declared the tirzepatide shortage resolved on October 2, 2024, and the semaglutide shortage resolved on February 21, 2025 [3]. Liraglutide injection was still listed as in shortage in FDA's database when we checked on October 25, 2026 [4]. The [Status Tracker](/regulation/tracker/) shows the current shortage status for each peptide, and [compounded vs FDA-approved semaglutide](/compare/compounded-vs-fda-approved-semaglutide/) explains the difference between the two [3].

## Sources

1. [Federal Register: List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B (91 FR 23431, May 1, 2026)](https://www.federalregister.gov/documents/2026/05/01/2026-08552/list-of-bulk-drug-substances-for-which-there-is-a-clinical-need-under-section-503b-of-the-federal)
2. [Federal Register: Extension of Comment Period (91 FR 38719, June 26, 2026)](https://www.federalregister.gov/documents/2026/06/26/2026-12937/list-of-bulk-drug-substances-for-which-there-is-a-clinical-need-under-section-503b-of-the-federal)
3. [FDA: FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize](https://www.fda.gov/drugs/drug-alerts-and-statements/fda-clarifies-policies-compounders-national-glp-1-supply-begins-stabilize)
4. [FDA: Drug Shortages database, liraglutide injection](https://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Liraglutide%20Injection&st=c)

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