FDA Snubs Ozempic and Similar Drugs from Key Compounding List
Published Date: 5/1/2026
Notice
Summary
The FDA is updating a special list of important drug ingredients that compounding pharmacies can use to make medicines. They decided not to add three popular drugs—semaglutide, tirzepatide, and liraglutide—to this list right now. People and companies have until June 30, 2026, to share their thoughts, which could affect future drug availability and costs.
Analyzed Economic Effects
3 provisions identified: 0 benefits, 2 costs, 1 mixed.
Three Drugs Not Added Now
The FDA proposes NOT to add semaglutide, tirzepatide, and liraglutide to the Section 503B Bulks List. That means outsourcing compounding facilities may not lawfully compound using those bulk drug substances unless the substance later appears on the 503B Bulks List or the drug product is on FDA's drug shortage list at the time of compounding.
What FDA Won't Count As 'Clinical Need'
When deciding whether a bulk drug substance belongs on the 503B Bulks List, FDA says it will not treat supply issues (such as backorders), convenience of administration, or the cost of a compounded product versus an FDA-approved product as a basis for 'clinical need.'
Public Comment Deadline Set
FDA is accepting electronic or written comments on this notice through June 30, 2026. Stakeholders must submit comments by 11:59 p.m. Eastern Time on June 30, 2026 for them to be considered.
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Key Dates
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