FDA Halts Sale of Off-Brand Ozempic and Other GLP-1 Drugs

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Medically reviewed by Drugs.com.

By I. Edwards HealthDay Reporter

FRIDAY, May 23, 2025 — A federal deadline ending sale of off-brand weight-loss and diabetes medications is now in effect, cutting off access to drugs many patients count on.

The U.S. Food and Drug Administration (FDA) already declared that shortages of popular GLP-1 medications have ended, CNN reported. Those medications include semaglutide (Ozempic and Wegovy) and tirzepatide (Mounjaro and Zepbound).

That means compounded versions of these drugs made by smaller pharmacies and sold without FDA approval can no longer be legally produced or sold.

The deadline for stopping production and distribution of compounded tirzepatide passed in March. Thursday was the final day for compounded semaglutide.

For thousands of people, these compounded medications were more affordable than brand-name versions. Olympia Pharmaceuticals alone supplied more than 70,000 people each week, according to its chief financial officer, Josh Fritzler.

“We had to be transparent. … ‘OK, we’re going to prioritize the shortage need for the next three months to make sure that we can meet as many patients as possible before this transition is over. Because a lot of them are scared that they’re going to run out,' " Fritzler told CNN.

Michelle Pierce, 25, from Texas, said compounded semaglutide helped her lower her blood sugar and avoid back surgery. But with the end of availability, she told CNN, "I don’t really have any other options. I absolutely cannot afford to completely pay out of pocket.”

Some doctors, however, worry about the safety of compounded versions.

“You just don’t have that security of [compounded versions] being FDA-regulated. I don’t know what’s in this compound. I don’t know about purity, I don’t know about safety. I don’t know about dosing. I don’t know about drug interactions,” said Dr. Jody Dushay, an endocrinologist at Beth Israel Deaconess Medical Center in Boston. “I really wouldn’t want to be responsible for that.”

While she doesn’t support use of compounded GLP-1s, Dushay predicted that the new restrictions may strain the supply of approved drugs, especially at initial dosages.

The FDA said that drugmakers now have enough manufacturing capacity to meet current and expected demand, CNN reported.

Novo Nordisk said it is confident in its supply of semaglutide, CNN said. Meanwhile, Eli Lilly, maker of tirzepatide, warned that unapproved knockoffs could be dangerous.

“Anyone continuing to sell mass-compounded tirzepatide, including by referring to it as ‘personalized,’ ‘tailored’ or something similar, is breaking the law and putting patients at risk,” a statement from the company said.

To improve access, both companies have launched online platforms and have started offering single-dose vials. Still, many patients face steep costs and limited insurance coverage.

“The shortage is much better; insurance coverage is much worse,” Dr. Disha Narang, an endocrinologist at Northwestern Medicine Lake Forest Hospital in Illinois, said.

Lee Rosebush is chair of the Outsourcing Facilities Association, which represents large-scale compounding pharmacies. He said his trade group filed lawsuits challenging the FDA’s decision to remove the drugs from the shortage list. It lost both cases.

“What I’m afraid of happening at the end of this week when the deadline hits is that patients and providers won’t have access to the medications they need, and they will be financially impacted as they move forward because of this," Rosebush told CNN.

Pierce, the Texas patient, said she has stocked up on six months of medication but is worried for others.

Some people are just now starting the compounded meds unaware they could quickly lose access, she said.

Sources

  • CNN, May 21, 2025

    • Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.

    Source: HealthDay

    Posted : 2025-05-24 00:00

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