Compounding

Compounded GLP-1: What the FDA Says

The FDA's own statements on compounded GLP-1 drugs and on the status of the semaglutide and tirzepatide shortages.

By the GLPFinders Research Desk. Sources checked October 30, 2026. Not independently medically reviewed. Editorial standards · Request a correction

This guide is educational and is not medical advice. A listing in this directory is not a recommendation. Talk to a licensed clinician about your own situation.

What compounded means to the FDA

The FDA says compounded drugs are not FDA approved. It says this means the agency does not review compounded drugs for safety, effectiveness or quality before they are marketed.

The FDA also says compounded drugs should only be used in patients whose medical needs cannot be met by an FDA-approved drug.

Shortage status

In a declaratory order dated December 19, 2024, the FDA determined that the tirzepatide injection shortage was resolved. In a declaratory order dated February 21, 2025, it determined the same for semaglutide injection.

On its April 1, 2026 entry, the FDA said tirzepatide and semaglutide did not appear on the 503B bulks list or on its drug shortage list. Shortage status can change, so check the FDA page for the current position.

What this means for a listing

A clinic appearing in this directory is not a statement that its medication is approved, safe or legally compounded. Ask any clinic which product it dispenses, who prepares it, and who prescribes it.

Sources

Each passage below was copied from the page named, which was opened and checked on October 30, 2026. Agency pages change, so open the link for the current text.

FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss
“Compounded drugs should only be used in patients whose medical needs cannot be met by an FDA-approved drug.”
FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss
“compounded drugs are not FDA approved. This means the agency does not review compounded drugs for safety, effectiveness or quality before they are marketed.”
Declaratory Order: Resolution of Shortages of Semaglutide Injection Products (Ozempic and Wegovy)
“FDA has determined that the semaglutide injection product shortage is resolved.”
Declaratory Order: Resolution of Shortages of Tirzepatide Injection Products (Mounjaro and Zepbound)
“FDA determines that the tirzepatide injection product shortage is resolved.”
FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize
“Tirzepatide and semaglutide do not currently appear on the 503B bulks list or on FDA’s drug shortage list.”