FDA Ends Compounding for Popular GLP-1 Drugs

 

Due to limited availability and high costs, many Americans have turned to compounding pharmacies for weight-loss medications. However, this alternative will soon be unavailable.

Federal regulations allow compounding pharmacies to produce copies of drugs during shortages. Recently, though (as it’s been widely reported) regulators declared that popular weight-loss drugs Wegovy and Zepbound are no longer in short supply. As a result, consumers who have relied on less expensive, compounded versions — often obtained through telehealth services or medical spas — will need to find other options.

This has left patients like Amanda Bonello, a mother of three from Marion, Iowa, feeling anxious. She has been using a compounded version of tirzepatide, the active ingredient in Eli Lilly’s Mounjaro (for diabetes) and Zepbound (for weight loss). With Zepbound’s retail price averaging nearly $1,300/month, Bonello fears she won’t be able to afford the brand-name drug.

She said,

It feels like we’re stranded while Big Pharma controls the only food supply, letting those who can’t pay go without.

In response, industry groups representing compounding pharmacies and suppliers have filed lawsuits to continue selling these medications. Meanwhile, patients have launched an online petition urging regulators to extend the use of compounded GLP-1 drugs, approve generic alternatives, or push pharmaceutical companies to lower prices. The petition also calls for health insurers to cover these medications.

What’s the status of compounded Wegovy and Zepbound?

Soon, compounding pharmacies will no longer be permitted to produce and sell these weight-loss drugs for widespread use. The government has set a transition period, with compounded versions of Zepbound and Mounjaro already being phased out. Compounded semaglutide (found in Wegovy and Ozempic) will remain available for a short time longer.

In December, the FDA announced that tirzepatide was no longer in shortage, giving pharmacies until February 18 to stop compounding, distributing, or dispensing the drug. Suppliers selling bulk batches have until March 19 to cease distribution. The Outsourcing Facilities Association, an industry trade group, has sued the FDA in Texas to delay enforcement of these restrictions.

In response, the FDA has asked the court to deny the request, arguing that upholding its decision would protect patients and align with Congress’ goal of encouraging drug development while permitting compounding only in temporary shortages.

Last month, the FDA also determined that Novo Nordisk’s semaglutide supply had stabilized. Pharmacies must stop selling compounded semaglutide by April 22, while suppliers must halt distribution by May 22.

What should patients who take compounded weight-loss drugs expect?

Pharmacists supplying compounded weight-loss and diabetes drugs are already informing customers about the upcoming changes. Some have stopped refilling prescriptions, while others are hesitant to start new patients on compounded versions, knowing they will soon need to switch to the brand-name medications.

A study found that within a year of stopping semaglutide, a group of 327 patients from the U.S., Europe, and Japan regained two-thirds of the weight they had lost while on the drug. The study also reported a decline in their overall health.

Jennifer Burch, an independent compounding pharmacist in North Carolina, educates her patients about how compounded drugs are only available when the FDA deems the brand-name versions to be in shortage.

She frequently hears from people interested in starting on compounded tirzepatide. But with the shortage ending, she advises against it if they cannot afford the brand-name medication long-term.

She said:

We want to be upfront with them… We don’t want them to feel abandoned.

Some patients are asking doctors for long-term prescriptions to stockpile the medication for up to a year. However, doctors are reluctant, as they need to monitor patients’ weight loss and overall health.

Burch said:

I had a provider tell me yesterday, ‘I’m worried about writing a 12-month prescription. What if the patient comes back weighing 100 pounds? That’s not the goal.

Are efforts being made to lower brand-name weight-loss drug prices?

Most major employers and private insurers cover diabetes medications like Ozempic and Mounjaro. However, fewer than half of large employers cover GLP-1 medications for obesity. As a result, many patients must pay out of pocket for drugs that can cost about $1,300 per month before discounts.

Congress has scrutinized pharmaceutical companies over the high costs of these drugs, prompting some manufacturers to introduce discounted options.

Eli Lilly reduces price for Zepbound

As was reported by major media outlets, including Reuters, Eli Lilly reduced the cash price for lower-dosage vials of Zepbound through its LillyDirect website. A one-month supply of 2.5 mg now costs $349, while the 5 mg version is priced at $499. Higher dosages (7.5 mg and 10 mg) are now $599 and $699 per month, respectively, with an initial discount to $499 for the first fill and refills within 45 days.

Meanwhile, legal battles over the FDA’s decision continue. The Outsourcing Facilities Association recently sued the agency again, challenging the determination that Wegovy and Ozempic are no longer in shortage. The group had previously sued over the ruling on tirzepatide.

In the tirzepatide lawsuit, the OFA argued that the FDA’s decision effectively created a new rule without proper regulatory procedures. The court has not yet issued a ruling, and the FDA has stated it will hold off enforcing the February 18 deadline until the court decides.

For Bonello, the FDA’s declaration means she must now explore other options. Initially, she had hoped to switch to compounded semaglutide, but she realizes that’s only a temporary fix.

Her employer-sponsored insurance covers GLP-1 medications for diabetes but not for weight loss. Since she doesn’t have diabetes — though her blood sugar is elevated, and her family has a history of the disease — she isn’t eligible for coverage.

Even with Eli Lilly’s discounted $499 price for higher dosages, Bonello says she still can’t afford it while covering her other expenses.

“That’s more than my phone bill and car insurance combined,” she said.

Your responses and feedback are welcome!

Source: “These discounted versions of popular weight-loss drugs are going away: What to know,” USA TODAY, 3/2/25
Source: “Lilly offers weight-loss drugs in vials at a discount to fight competition,” Reuters, 2/25/25
Image by Anna Shvets/Pexels

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