FDA GLP-1 Compounding Policy: Tirzepatide Shortage Resolution and Semaglutide Rules Explained

Last Updated: March 2026

Between 2022 and 2025, the FDA issued a series of policy decisions that determined whether compounded versions of GLP-1 drugs — semaglutide (Ozempic, Wegovy) and tirzepatide (Mounjaro, Zepbound) — could be legally manufactured and dispensed. These decisions affected millions of patients using compounded versions for weight loss and diabetes management at a fraction of brand-name prices.

Why Compounded GLP-1 Drugs Became Legal

Under the Federal Food, Drug, and Cosmetic (FD&C) Act, compounding pharmacies are normally prohibited from making copies of commercially available FDA-approved drugs. However, an exception exists when a drug is officially listed on FDA’s Drug Shortages database.

Starting in 2022, an unprecedented surge in demand for GLP-1 receptor agonists created nationwide shortages. The FDA placed semaglutide injection and tirzepatide injection on the drug shortage list, which legally permitted:

503A pharmacies (state-licensed, patient-specific compounders) to compound and dispense these medications based on individual prescriptions
503B outsourcing facilities (larger-scale compounders supplying healthcare facilities) to compound and distribute them under specified conditions

This opened the door for telehealth platforms and compounding pharmacies to offer compounded semaglutide and tirzepatide at prices 50-80% below brand-name versions, driving enormous market growth.

The Tirzepatide Shortage Timeline: October Through December 2024

October 2, 2024: FDA Declares Tirzepatide Shortage Resolved

On October 2, 2024, FDA determined the tirzepatide injection shortage had been resolved. The agency confirmed with the manufacturer (Eli Lilly) that their stated product availability and manufacturing capacity could meet present and projected national demand.

This determination immediately triggered the legal restrictions on compounding:

Section 503A pharmacies face restrictions on compounding drugs that are “essentially copies” of commercially available drugs outside of shortage conditions
Section 503B outsourcing facilities are prohibited from compounding copies of FDA-approved drugs not on the shortage list

FDA acknowledged that patients and prescribers might still see intermittent localized supply disruptions as products moved through the supply chain.

October 22, 2024: Court Challenge Remands the Decision

Compounding pharmacy organizations challenged FDA’s shortage determination in federal court, arguing the resolution was premature. A court remanded the decision back to the FDA for reevaluation.

During the reevaluation period, FDA issued a letter on October 17, 2024, outlining its intended enforcement approach — providing some temporary continuation for compounders.

December 19, 2024: FDA Reconfirms Shortage Resolved

After reevaluation, FDA issued a new declaratory order on December 19, 2024 reconfirming the tirzepatide injection shortage was resolved. To minimize disruption to patients currently on compounded tirzepatide, the agency provided wind-down periods:

503A state-licensed pharmacies: 60 calendar days from December 19, 2024 — meaning until February 18, 2025
503B outsourcing facilities: 90 calendar days from December 19, 2024 — meaning until March 19, 2025

After these dates, compounding tirzepatide in ways that depended on shortage-list status became subject to FDA enforcement.

Semaglutide: Still in Shortage as of Late 2024

As of December 19, 2024, semaglutide injection remained on FDA’s drug shortage list. The agency’s status note at that time: “Semaglutide injection: In shortage. Manufacturer has reported all presentations are available.”

This created a split-drug situation for patients and compounders:

Compounded tirzepatide was effectively ending
Compounded semaglutide remained legally permissible under the shortage exception

Patients seeking compounded GLP-1 treatment after February 2025 had to switch from tirzepatide to semaglutide formulations to remain within the legal framework.

What FDA’s Compounding Rules Actually Mean

FDA’s compounding framework under the FD&C Act establishes the following:

Compounded drugs are not FDA-approved. Unlike brand-name Ozempic or Mounjaro, compounded versions have not undergone FDA’s premarket review for safety, effectiveness, and quality. This does not mean they are automatically dangerous, but it does mean they lack the same manufacturing oversight and clinical testing requirements.

503A (patient-specific) compounders may compound based on individual valid prescriptions but:

May not regularly compound drugs that are essentially copies of commercially available drugs
Must compound based on the needs of individual patients, not stock distribution
Certain amounts are permissible even when a shortage is resolved, as long as compounding is not done “regularly or in inordinate amounts”

503B (outsourcing facility) compounders operate under stricter rules:

May not compound drugs that are essentially copies of FDA-approved drugs unless those drugs are on the shortage list
Once a shortage is resolved, bulk compounding of that drug must wind down within the established grace periods

FDA’s Stated Concerns About Compounded GLP-1 Drugs

FDA has separately documented concerns about unapproved GLP-1 products used for weight loss. These include:

Products that may not contain the correct dose of active drug
Products that may contain incorrect ingredients or contaminants
Semaglutide sodium and semaglutide acetate, which are not the same as the active ingredient (semaglutide) in FDA-approved products

The agency did not assert that all compounded GLP-1 products are unsafe, but the lack of premarket approval means quality varies significantly across compounders.

Current Status (as of Early 2026)

Tirzepatide compounding: Shortage-based compounding ended after March 19, 2025. Patients were expected to transition to brand-name Mounjaro or Zepbound, or switch to compounded semaglutide if still eligible.
Semaglutide compounding: Remains available based on the ongoing shortage determination. FDA continues to monitor and will apply wind-down rules if the shortage is declared resolved.
FDA enforcement: The agency stated it may take action for violations of any other statutory or regulatory requirements even during wind-down periods, including substandard quality products.

What This Means for Patients

If you used compounded GLP-1 medications and your prescriber used tirzepatide:

Compounded tirzepatide became unavailable from licensed pharmacies after March 2025
Your prescriber can evaluate whether brand-name Zepbound or compounded semaglutide is appropriate
Consult your prescriber before switching drugs or doses — the pharmacokinetics differ between tirzepatide and semaglutide

If you used compounded semaglutide:

Compounded semaglutide may remain available depending on ongoing shortage status
Verify current status with your compounding pharmacy and check FDA’s Drug Shortages Database

Sources

FDA (December 19, 2024): “FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize.” Archived via Wayback Machine
FDA Drug Shortages Database: https://dps.fda.gov/drugshortages
FDA (2024): “FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss”
Federal Food, Drug, and Cosmetic Act, Sections 503A and 503B

FDA GLP-1 Compounding Policy: Tirzepatide Shortage Rules