FDA Proposes Limits on Ingredients Used to Make Compounded GLP-1 Drugs
Updated 23 September 2026
What Is Happening
The U.S. Food and Drug Administration proposed excluding three ingredients used in GLP-1 medicines—semaglutide, tirzepatide and liraglutide—from its 503B bulks list. That list helps determine which raw drug ingredients certain FDA-registered facilities may use to prepare compounded medicines.
Compounding means mixing or altering ingredients to make a medicine for particular patient needs. The FDA is the regulator proposing the change; the facilities preparing these medicines would be affected. In the April 30 announcement, the FDA said it had found no clinical need for those facilities to compound the three drugs from raw ingredients.
The proposal concerns this particular route for making compounded medicines. It does not withdraw approved medicines containing the same ingredients. The announcement invited public comments through June 29 before a final decision, so it should be read as a proposal at that time rather than a blanket ban already in force.
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