Earlier this month, the U.S. Food and Drug Administration declared that the tirzepatide shortage was over. For many people unable to fill prescriptions for the tirzepatide drugs Mounjaro (for diabetes) or Zepbound (for obesity) since the start of the shortage in 2022, this was welcome news.[1]

But the announcement also caused confusion, controversy, and even a lawsuit.[2] In an apparent response to the pushback, the FDA announced that it would review its decision and keep tirzepatide on its shortage list for now.

The issue is that removing tirzepatide from the list amounts to a ban on the inexpensive knockoff versions of the drug known as compounded tirzepatide. Compounding pharmacies are permitted to make copies of branded medications under certain circumstances such as shortages.

One commenter on Reddit described being blindsided by the FDA’s initial decision to take tirzepatide off the shortage list, an announcement that was accompanied by a reminder that compounding pharmacies would no longer legally be permitted to sell tirzepatide “regularly or in inordinate amounts.”[3]

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“I was completely in the dark. Is it truly no longer available as a compound? If so, I am screwed,” the user wrote. “I am down 45 pounds, but I still have 50 to go. What the heck are people supposed to do?” The user added that they could not afford the name-brand version of the drug.

The original FDA announcement also sparked outcry from some pharmacists and industry groups, who said the removal of the drug from the shortage list at this point would leave patients without access.

At an industry roundtable last week, compounding pharmacists voiced their concern that patients may still be having trouble locating Mounjaro and Zepbound.

A spokesperson for Eli Lilly, which makes Mounjaro and Zepbound, told Everyday Health in an email that “patients’ experiences looking for a particular dose of medicine in their local pharmacies may vary.”

The spokesperson continued, “The supply chain is complex, especially for refrigerated medicines, and there may be many reasons why a particular pharmacy does not have a particular dose of the medicine in stock. Because Lilly’s FDA-approved medicines are available, patients should not be exposed to the higher risks posed by untested, unapproved knockoffs. The entities currently mass-producing and mass-marketing compounded and counterfeit tirzepatide need to stop immediately.”

What Are the Potential Risks of Compounded Drugs?

The shortage was driven by an astronomical spike in demand for the new generation of injectable weight loss and diabetes drugs — specifically tirzepatide and semaglutide, the active ingredient in Ozempic and Wegovy. Compounded versions of the drugs became popular at licensed pharmacies but also at med spas and among people who acquired supplies and mixed the doses themselves.

While the FDA recognizes that compounded drugs fill an important need, the agency warns that compounded drugs “pose a higher risk to patients than FDA-approved drugs because they do not undergo FDA premarket review for safety, effectiveness, or quality.”[5]

Pharmacies compound drugs under different conditions. For example, a pharmacy with a compounded sterile preparations pharmacy specialty certification (BCSCP) follows specific sterile practices when compounding drugs to safeguard patients. But if a person purchases a compounded drug online or from an uncertified pharmacy, they may face risks.[6]

Juliana Simonetti, MD, codirector of the comprehensive weight management program at the University of Utah in Salt Lake City, empathizes with patients who are desperate for the blockbuster weight loss drugs but cannot access them, either because of shortages or cost.

“I know patients are desperate to get the drug. As a medical community, we need to push for better access to these drugs. But I don’t think compounding is the solution here,” Dr. Simonetti says, adding that her main concern is inconsistency in how compounding is done, and that compounded drugs can carry higher risks and patients can’t always be sure what is in them.

Compounding Pharmacies Are Pushing Back

Removing tirzepatide from the shortage list means that patients who have a prescription for compounded tirzepatide may need to go through a prior authorization with their insurance company and obtain a new prescription for the name-brand drug, says Scott Brunner, CEO of the Alliance for Pharmacy Compounding.

“You have to have separate scripts for a compounded drug and a brand-name drug,” he says.

Insurance companies often do not cover weight loss drugs, which could leave patients to pay out of pocket.

Eli Lilly has started offering discounts for both self-payers and people who are insured but whose insurance does not cover Zepbound. Still, the cost can be as much as $650 per month.[7]

“I think a couple things could happen. There will be patients who have sticker shock when they see how much being on the brand-name drug is and decide the investment isn’t worth it anymore,” Brunner says, adding that other patients will likely see a lag in care as they wait for pharmacies to stock Zepbound or for insurance to approve their coverage.

At an industry roundtable led by the Alliance for Pharmacy Compounding, John Herr, a pharmacist at Town and Country Compounding in Ramsey, New Jersey, expressed his worry that, should compounded tirzepatide become illegal, patients might turn to potentially dubious ways of getting the medication, such as mixing it themselves or ordering medications labeled as tirzepatide from other countries.

Patients on Compounded Tirzepatide May Have Some Loopholes

It is currently legal for compounding pharmacies to sell compounded tirzepatide. But should the drug be taken off the drug shortage list, there may still be one loophole that compounding pharmacies can use.

“If someone continues to dispense compounded tirzepatide that is a copy of the FDA-approved drug — the same dosage, form, strength, and formulation — they are in violation of FDA guidance and the law,” Brunner says. “But that only pertains to copies.”

Creating dosages that are not available from Eli Lilly or are in different forms could allow compounding pharmacies to continue to provide tirzepatide to patients, says Allison Hill, PharmD, director of professional affairs for the American Pharmacists Association.

For compounding pharmacies, the stakes are high. “This shortage is not like other shortages,” Brunner says. “The number of patients prescribed compounded versions of this drug during the shortage is not like what we experience with other drugs.”

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