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‘Compounded’ weight-loss drugs are a growing problem for state regulators

by Anna Claire Vollers, NC Newsline
July 8, 2024

Anna Wysock’s “aha” moment arrived in an Ohio amusement park, as she got ready to ride a roller coaster with her 7-year-old son: The safety bar across her lap would only click into place once. The attendant told her it had to click twice, or she couldn’t ride. She was mortified.

“I had to do the walk of shame and get off the roller coaster and let my 7-year-old ride it with his cousin,” Wysock, an elementary school teacher and married mother of two, said of the 2022 incident. “I thought, ‘Anna, you’ve got to get yourself together.’”

Three months after the roller coaster incident, Wysock got a prescription for Mounjaro, an injectable diabetes drug that can be used for weight loss. Her insurance didn’t cover it, but a manufacturer’s coupon cut the cost to $25 per month. In six months, combined with diet and exercise changes, it helped her shed nearly 60 pounds.

Then the discount ended, raising the price to about $1,000 per month. Friends told her about a local clinic that offered cheaper, compounded versions of weight-loss drugs, and she got a prescription costing $150 per month. She began losing weight again.

To create a compounded drug, pharmacists reformulate the active ingredients in a commercial drug to customize it for an individual patient. Wysock was concerned about making the switch, fearing that the compounded version would cause unfamiliar side effects, “but it was worth it to me to try.”

It’s not a normal situation that a blockbuster drug immediately goes on shortage and meets criteria for compounding pharmacies to compound it. I don’t think we’ve ever seen anything like this.

– Tenille Davis, chief advocacy officer for the Alliance for Pharmacy Compounding

Drugs prescribed for weight loss such as Mounjaro, Ozempic, Wegovy and Zepbound are popular, expensive, and in short supply. To meet the demand, many physicians, medical spas, IV infusion clinics, telehealth entrepreneurs and pharmacies are jumping on the opportunity to provide compounded versions of the weight-loss medications, which haven’t been on the market long enough to have generic equivalents.

State regulators are having trouble keeping up.

The U.S. Food and Drug Administration regulates commercial drugs, but the licensing and oversight of compounding pharmacies falls to states. States including Idaho and Tennessee have announced investigations into illegal dispensing by medical spas and other providers, while states such as California are looking to beef up their oversight.

“It’s not a normal situation that a blockbuster drug immediately goes on shortage and meets criteria for compounding pharmacies to compound it,” said Tenille Davis, an Arizona pharmacist and the chief advocacy officer for the Alliance of Pharmacy Compounding, an industry group representing compounding pharmacists.

“I don’t think we’ve ever seen anything like this.”

A cheaper alternative

Compounding pharmacies are allowed to make a medication that’s essentially a copy of a commercially available drug if its active ingredients are listed on the FDA’s drug shortage list. The active ingredient in weight-loss drugs such as Wegovy and Zepbound is either semaglutide or tirzepatide, and both are on the list.

“As the demand continues to grow, there continues to be a shortage of conventionally manufactured product, and compounding pharmacies are filling that need,” said Davis. “Compounding pharmacies have been able to step in and fill some of those gaps in the marketplace.”

Most states have similar compounding rules, though some states — including California and Texas — are stricter than others. Enforcement also varies.

In Mississippi, regulators have told doctors and other providers to stop prescribing compounded medications for weight loss — period. The state medical board has a rule that only medications that have been FDA-approved for weight loss can be prescribed for weight loss — meaning compounded drugs don’t qualify.

But many states and compounding pharmacies aren’t sure where the lines are. States including Kansas and New Jersey have had to issue statements clarifying their regulations. Last spring, North Carolina and West Virginia issued warnings that compounding weight-loss drugs wasn’t allowed — only to amend their statements after determining they had misinterpreted FDA guidance.

Mixed signals in NC?

Despite their effectiveness, the popularity and related expense of weight loss drugs like Ozempic and Wegovy led North Carolina Treasurer Dale Folwell, who oversees the state Health Plan that covers North Carolina teachers and state employees, to end coverage of the medications as of April 1 for weigh loss purposes.

Notably however, in recent days, Novo Nordisk — the pharmaceutical company that manufactures Ozempic and Wegovy — announced that it would be making a $4.1 billion investment to expand its facility in Johnston County. The expansion is expected to add 1,000 jobs to the workforce at the facility.

Federal law requires most U.S. compounding pharmacies to make medications for specific patients. They aren’t supposed to bulk manufacture medications unless they’re registered with the FDA as “outsourcing facilities,” which follow a stricter set of federal regulations.

But some states have found compounders breaking those rules.

In May, for example, Idaho’s licensing agency announced that regulators had discovered videos of health professionals filling syringes of weight-loss medications that weren’t compounded for specific patients, and then sending those syringes to patients, which is illegal under state law.

A compounding pharmacy in Nashville, Tennessee, that was producing tens of thousands of doses of compounded weight-loss medications shut down last year. It had been shipping its drugs nationwide. After state regulators inspected the facility and issued a disciplinary order requiring the company to make several changes before it could resume compounding, an executive died by suicide and the pharmacy’s owner chose to close.

And in Florida, a physician told the state pharmacy board he’d been approached by representatives from a multistate compounding pharmacy that wanted him to write prescriptions for their specific compounded semaglutide product — a form of prescription solicitation that’s likely illegal, Carter said.

Compounders generally don’t have to register with the FDA, and they aren’t required to report which drugs they’re compounding. That means there’s no way to know exactly how much semaglutide or tirzepatide they are dispensing, said Davis.

‘Like Whac-A-Mole’

To protect patients, the FDA enforces strict safety and quality requirements for drug manufacturers and for the small subset of compounding pharmacies registered as outsourcing facilities. The idea is that companies that are bulk manufacturing drugs need closer oversight than smaller compounding pharmacies that are merely customizing drugs for individual patients.

Compound pharmacies that bulk produce weight-loss drugs without FDA approval are doing so without that oversight.  And because compounding pharmacies aren’t required to report instances of patient harm involving their medications, problems may go undetected.

“It’s kind of like ‘Whac-A-Mole,’” said Al Carter, a pharmacist and executive director at the National Association of Boards of Pharmacy. He said state boards will only investigate when they receive a complaint.

“There are bad actors out there, purporting to be compounding pharmacies that are licensed in specific states or have the credentials to be able to compound when in actuality they don’t,” said Carter. “My understanding is most licensed, legitimate pharmacies aren’t compounding” weight-loss medications.

Most of the complaints that state regulators are hearing, he said, come from patients who tried to purchase their medications online. The National Association of Boards of Pharmacy recently released a report that found illegal online pharmacies — many operating outside the United States — sell substandard or fake weight-loss medications, or misrepresent the products they sell.

But even some domestic, legally operating clinics misrepresent the products they offer. Some clinics and online pharmacies advertise a “generic” form of semaglutide, even though the FDA hasn’t approved a generic form of semaglutide or tirzepatide.

Meanwhile, pharmaceutical giants Novo Nordisk and Eli Lilly have gone on the offensive, filing dozens of lawsuits in multiple states against medical spas, weight-loss clinics and pharmacies. Many of the suits allege the companies falsely marketed their compounded products as commercial medications.

An Eli Lilly spokesperson told Stateline in a statement that “Lilly will continue to pursue legal remedies against those who falsely claim their products are Mounjaro, Zepbound, or ‘FDA-approved’ tirzepatide, including certain med-spas, wellness centers, online retailers, and compounding pharmacies.”

Some states are focusing their investigations specifically on medical spas and IV infusion clinics that offer compounded weight-loss medications. The California State Board of Pharmacy recently discussed expanding its oversight of IV hydration clinics, noting that even when their drug products are from licensed compounding pharmacies, clinic staff may not be giving them to consumers legally.

And in Texas, some physicians are pushing for legislation to tighten state oversight of medical spas following the death last July of a woman who died after receiving an IV infusion treatment.

But ultimately the burden rests on patients to figure out whether the medications they’re taking were made by a licensed and reputable compounder.

For patients like Wysock, compounded versions of weight-loss medications have been life- changing. Wysock said her compounded tirzepatide has enabled her to continue to lose weight, to maintain a healthier lifestyle and to be present for her family and students.

“As a teacher you’re on your feet all day long, and then coming home to two kids, I was exhausted by the weekend,” she said. “I used to take naps every weekend. That was a ‘nonnegotiable.’ Now it’s not a necessity anymore.”

This report was first published by Stateline, which like NC Newsline, is part of the national States Newsroom network.

NC Newsline is part of States Newsroom, a nonprofit news network supported by grants and a coalition of donors as a 501c(3) public charity. NC Newsline maintains editorial independence. Contact Editor Rob Schofield for questions: info@ncnewsline.com. Follow NC Newsline on Facebook and X.