As the Food and Drug Administration clamps down on off-brand weight loss medications, Seattle-area residents are stocking up on supplies and fretting about the future of their treatment.

Over the past few years, demand for blockbuster medications like Ozempic, Wegovy and Zepbound skyrocketed. These drugs are typically prescribed to address a range of health issues, including diabetes and obesity. However, they're also pricey, and health insurance plans often don't cover them for weight loss use.

As a result, a market for cheaper, off-brand versions of their active ingredients — semaglutide and tirzepatide — has proliferated, serving people looking for weight loss drugs at a fraction of the cost. Now, the FDA is beginning to crack down on the off-brand market, leaving people who depend on it in the lurch.

Unlike name-brand products, compounded drugs are not approved by the FDA. However, the agency permits pharmacies to make and sell them during declared drug shortages. Until recently, semaglutide and tirzepatide were both in short supply because of high demand.

According to agency policy updates, the tirzepatide shortage was resolved in October, and the semaglutide shortage ended in February. To prevent disruptions, the agency gives compounding pharmacies a grace period to phase out production and sales. The deadline for compounding facilities to stop producing tirzepatide came in late March. The final cutoff for semaglutide came in late May.

Some health professionals are glad that the FDA has begun clamping down on the market for compounded weight loss drugs. Because they don’t undergo FDA approval, the safety and efficacy of compounded medications are hard to verify.

“You can't guarantee the quality of them, and there's a lot of risk,” said Nicole Hamlin, a certified physician assistant and founder of Vitality Weight Management in Ballard. “I've known a lot of patients who have had detrimental outcomes from these medications.”

But for many who have had positive experiences with low-cost alternatives, the FDA decision is disheartening.

For almost a year, Tina S. of Snohomish had been going to her doctor for weekly weight loss consultations. Each appointment included a weigh-in, diet counseling and an injection of compounded tirzepatide. Over the course of her treatment, Tina lost 65 pounds. She also has polycystic ovarian syndrome, and the medication helped relieve some of her symptoms.

But during an appointment in late March, her doctor told her that she wouldn’t be able to get compounded tirzepatide at the clinic anymore. “I literally went home in tears because I had no warning,” said Tina, who asked to withhold her full last name to protect her privacy as she shared personal health details.

As a temporary workaround, Tina’s doctor wrote her a prescription for compounded tirzepatide, and Tina reached out to a compounding facility directly to get the medication. Worried about future availability, Tina decided to buy a six-month supply, which cost around $1,450.

The cost is still much less than brand-name tirzepatide. Sold by pharmaceutical company Eli Lilly under the names Zepbound and Mounjaro, the medication’s list price is over $1,000 for a one-month supply. For people like Tina, whose insurance doesn’t cover the drug for weight loss use, discounts can bring the out-of-pocket price down to around $600 a month for the dose she needs. But that’s still beyond what Tina can afford.

Tina described her background as middle class, but her husband isn’t working right now. “There’s no way,” she said, about paying full price for brand-name versions of the drug. “I couldn’t pay my bills if I did that.”

She bought her six-month supply of compounded medication just in time.

“A lot of people are going to be stuck,” said William Dietz, director of the STOP Obesity Alliance, a coalition of organizations affiliated with George Washington University. “They had access to compounded medications, and now they don't.”

Peter Temes was prescribed Ozempic by his doctor three years ago. At the time, severe shortages made getting it from a pharmacy like Bartell Drugs impossible. He found it at a specialty pharmacy. But even after insurance, it cost $1,500 a month at the time.

Eventually, he found a nurse practitioner who prescribed him compounded semaglutide, the active ingredient in Ozempic, and Temes was able to get it for less than $300 per month.

“It was great,” he said. “Every three months, I’d get this little dry ice pack on my porch. Until it stopped.”

Earlier this year, Temes’ nurse practitioner got a cease-and-desist from a pharmaceutical company over the sale of compounded weight loss drugs. Temes is considering his options for getting brand-name weight loss medication. As of late May, he had just a month’s supply left.

His insurance no longer covers Ozempic for weight loss use. Pharmaceutical company Novo Nordisk offers Ozempic for patients paying out of pocket for $499 a month. Temes is getting price estimates from different pharmacies before he makes a decision.

“I can swing it,” he said of the $499 a month price. “But it’s a lot.”

Temes and his wife are approaching retirement. Seen one way, spending more on weight loss medication means setting aside less for the future. Seen another, paying for the brand-name version of the drug is a worthy investment in his long-term health.

“This is going to help me not become diabetic,” he said. “This is going to help me not have debilitating strain on my joints.”

Hamlin, who prescribes branded medications, recognizes the cost can be prohibitive for most people. She is optimistic that manufacturers of brand-name weight loss drugs will continue to reduce the cost of their medications, especially in response to competition from the compounded market.

Last week, to lure customers from the compounded market, Novo Nordisk announced a discount for new customers of a one-month supply of medication for $199. The price is set to leap back to $499 at the end of June.

In the meantime, some compounding pharmacies are trying to work around the bans by tweaking their recipes, such as by adding additional ingredients like vitamin B12. Whether those pass muster will depend on how hard the FDA goes after compounders, said Marta Wosińska, senior fellow at the Center on Health Policy at the Brookings Institution.

“Compounding was never intended as a way to lower prices,” said Wosińska. The process is typically used to develop alternative medications to accommodate allergies, for example, or liquid forms of drugs for people who can’t swallow. That the compounded weight loss market grew so big and so wide-reaching is “a very unusual situation.”

People who have come to rely on it are now feeling the rug pulled out from under them.

Tina S. can’t imagine her life without compounded weight loss medication. In addition to helping her lose weight, she thinks it’s made her more physically active and changed the way people treat her.

She’s begun taking lower doses than usual, hoping to stretch out her supply for longer while she considers what to do next. For now, she said, “It seems to be working OK.”

A previous version of this story misstated the final cutoff deadline for producing compounded semaglutide. It came late May.

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