FDA to Restrict Compounded Weight Loss Drugs Like Wegovy and Zepbound

The availability of compounded versions of popular weight loss drugs, including Wegovy and Zepbound, is set to decrease after a recent U.S. court ruling. A federal judge declined to grant an injunction that would have allowed compounding pharmacies to continue producing these versions.

What Are Compounded Weight Loss Drugs?

Compounded drugs are customized versions of FDA-approved medications, created by licensed pharmacies but not directly regulated or inspected by the U.S. Food and Drug Administration (FDA). They are typically permitted when:

The original drug is on the FDA’s shortage list
A patient requires an alternative formulation due to allergies or other medical needs

Why Is the FDA Cracking Down on Compounded GLP-1 Drugs?

In recent years, weight loss medications like Ozempic, Wegovy, Zepbound, and Mounjaro have surged in popularity, leading to temporary shortages. However, manufacturers Eli Lilly and Novo Nordisk now report they can meet demand, prompting the FDA to remove these drugs from the shortage list.

Despite this, the Alliance for Pharmacy Compounding filed a lawsuit in October, arguing that the FDA prematurely ended the shortage designation for tirzepatide, the active ingredient in Zepbound and Mounjaro. The FDA had previously paused enforcement actions, but it has now set deadlines for stopping compounded versions of these drugs.

Key Deadlines for Compounding Pharmacies

Immediate Halt: State-licensed compounding pharmacies must stop producing most GLP-1 drug copies (including tirzepatide and semaglutide).
March 19: Larger outsourcing pharmacies must stop making compounded Zepbound.
April 22: State-licensed pharmacies must stop making compounded semaglutide (Wegovy, Ozempic).
May 22: Larger outsourcing pharmacies must stop making compounded semaglutide, unless a pending court injunction allows them to continue.

What Should Patients Do?

If you are currently using a compounded GLP-1 drug, speak with your doctor immediately to transition to an FDA-approved version.

How to Reduce the Cost of FDA-Approved GLP-1 Drugs

Weight loss medications like Wegovy and Zepbound can cost over $1,000 per month without insurance. Here are some ways to save:

Check Manufacturer Coupons: Both Eli Lilly and Novo Nordisk offer discounts on their websites.
Direct-to-Consumer Platforms: Drugmakers now offer lower-cost options for uninsured patients.
Pharmacy Discount Programs: Some pharmacies provide savings plans for eligible customers.

FDA’s Warning About Compounded GLP-1 Drugs

The FDA has previously cautioned that compounded drugs do not undergo the same safety and quality checks as FDA-approved medications. Since compounded versions are made using raw ingredients, they bypass the FDA’s rigorous approval process, potentially leading to safety concerns.

Understanding the Differences: Zepbound, Wegovy, Ozempic, and Mounjaro

Zepbound (tirzepatide): FDA-approved for weight management in people with obesity or weight-related conditions.
Mounjaro (tirzepatide): FDA-approved for Type 2 diabetes, but some doctors prescribe it off-label for weight loss.
Wegovy (semaglutide): FDA-approved for weight loss and reducing cardiovascular risks.
Ozempic (semaglutide): FDA-approved for Type 2 diabetes, but often used off-label for weight loss.

Both tirzepatide and semaglutide work by regulating insulin, slowing digestion, and reducing appetite, making them effective for weight loss.

The Bottom Line

With the FDA cracking down on compounded GLP-1 drugs, many patients will need to switch to brand-name versions. If you’re currently using a compounded version, consult your doctor about alternatives and explore cost-saving options.