FDA Confirms Retatrutide Cannot Be Compounded Under Federal Law

Retatrutide is an investigational drug and is not FDA approved. FDA has stated that retatrutide cannot be used in compounding under the federal exemptions in sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act. There was no FDA shortage-based compounding authorization for retatrutide. Retatrutide remains investigational and there is currently no FDA-approved retatrutide product.

Aug 2026

U.S. Food and Drug Administration

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Retatrutide and Federal Compounding Law

Retatrutide is an investigational drug and is not FDA approved.

FDA has stated that retatrutide cannot be used in compounding under the federal exemptions in sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act.

Retatrutide should not be confused with FDA-approved GLP-1 medications that previously experienced shortages.

There was no FDA shortage-based compounding authorization for retatrutide.

Products marketed as "research use only" are not FDA-approved medications for human use. FDA has also taken enforcement action concerning products marketed as containing retatrutide.

Consumers should not interpret online availability of a product labeled retatrutide as evidence that the product is FDA approved, legally compounded for patient use, or equivalent to the investigational product being studied in Lilly-sponsored clinical trials.

Current Status

Retatrutide remains investigational.

There is currently no FDA-approved retatrutide product.

Federal regulatory status may change as the clinical-development and regulatory-review process progresses. This page should therefore be updated when authoritative FDA or Lilly information changes.

Source

U.S. Food and Drug Administration — Compounding and FDA: Questions and Answers