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

On May 1, 2026, FDA published a notice proposing not to put semaglutide, tirzepatide or 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 shows the current shortage status for each peptide, and compounded vs FDA-approved semaglutide explains the difference between the two ^[3].

Peptides in this update

• Semaglutide: FDA status, research and uses
• Tirzepatide: FDA status, research and uses
• Liraglutide: FDA status, research and uses

More news

• DEA telemedicine flexibilities run through 2026
• FDA advisers review seven peptides for compounding
• FDA warns 30 telehealth firms over compounded GLP-1 ads
• HHS interim policy covers 6 peptides for compounding
• Most peptides leave FDA's Category 2 list
• WADA 2027 List names peptides as S0 examples

Status of every peptide

• FDA Peptide Status Tracker

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)
2. Federal Register: Extension of Comment Period (91 FR 38719, June 26, 2026)
3. FDA: FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize
4. FDA: Drug Shortages database, liraglutide injection

Updated October 26, 2026. Educational information, not medical advice.