Anna Wysock’s “aha moment” came when she was preparing to ride a roller coaster with her 7-year-old son at an amusement park in Ohio: The safety bar that rested on her lap only clicked once. The attendant told her that it had to click twice before they could ride. She was stunned.
“I was so embarrassed that I had to get off the roller coaster and put my 7-year-old son on it with his cousin,” Wysock, an elementary school teacher and married mother of two, said of the incident in 2022. “I thought, ‘Anna, you’ve got to get a grip.’
Three months after the roller-coaster accident, Wysock received a prescription for Maunjaro, an injectable diabetes drug that could be used to lose weight. Insurance didn’t cover it, but a manufacturer coupon reduced the cost to $25 a month. Combined with diet and exercise changes, she lost about 60 pounds over six months.
Then the discount ended and the price rose to about $1,000 a month. A friend told her about a local clinic that offered cheaper compounded versions of the weight-loss drugs, and she picked up a prescription for $150 a month. She started losing weight again.
To make a compounded medication, a pharmacist combines active ingredients from over-the-counter medications to customize it for each patient. Wysock was hesitant to switch because she worried the compounded medications would cause unknown side effects, but “it was worth a try.”
“It’s not a normal situation for a blockbuster drug to go into short supply so quickly that pharmacies meet the criteria to dispense it. I don’t think we’ve ever seen anything like this before.”
– Tenille Davis, Chief Advocacy Officer, Pharmacy Dispensing Alliance
Drugs prescribed for weight loss, such as Maunjaro, Ozempic, Wegoby and Zepbound, are popular, expensive and in short supply. To meet demand, many doctors, medical spas, infusion clinics, telemedicine entrepreneurs and pharmacies are jumping on the opportunity to offer compounded versions of weight loss drugs whose generic equivalents have yet to be released.
State regulators are struggling to keep up.
The U.S. Food and Drug Administration regulates over-the-counter drugs, but states license and oversee compounding pharmacies. States such as Idaho and Tennessee have announced investigations into illegal compounding by medical spas and other pharmacies, and others such as California are considering increasing oversight.
“It’s not a normal situation for a blockbuster drug to quickly become in short supply and for compounding pharmacies to meet the criteria to dispense it,” said Tenille Davis, an Arizona pharmacist and chief advocacy officer for the Pharmacy Dispensing Alliance, a trade group that represents compounding pharmacists.
“I don’t think I’ve ever seen anything like this before.”
Cheaper alternatives
Compounding pharmacies are permitted to manufacture medicines that are virtual copies of over-the-counter drugs if the active ingredient is on the FDA’s drug shortage list. The active ingredients in weight loss drugs such as Wegovy and Zepbound are either semaglutide or tirzepatide, both of which are on the list.
“As demand continues to grow, there continues to be a shortage of traditionally manufactured products, and compounding pharmacies are filling that demand,” Davis said. “Compounding pharmacies have been able to come into the market and fill some of that gap.”
Most states have similar arbitration rules, but some states, such as California and Texas, have stricter rules than others. Enforcement also varies by state.
In Mississippi, regulators are forcing doctors and other health care providers Stop prescribing combination drugs They can’t just be prescribed for weight loss: State medical boards have rules that only FDA-approved drugs can be prescribed for weight loss, which means compounded drugs don’t qualify.
But many states and dispensaries aren’t sure where the line is. Kansas and New Jersey We had to issue a statement clarifying the regulations. North Carolina and West Virginia Although they issued a warning that the combination of weight loss drugs is not permitted, Fix it They retracted their statement after it was discovered they had misinterpreted FDA guidance.
Federal law requires most compounding pharmacies in the United States to manufacture drugs for specific patients. Compounding pharmacies cannot mass-produce drugs unless they are registered with the FDA as “outsourcing facilities.” Outsourcing facilities are subject to stricter federal regulations.
But dispensaries in some states have been found to be violating those rules.
For example, in May, the Idaho Department of Licensing Announced Regulators found videos showing health care workers filling syringes with weight-loss drugs that weren’t formulated for a specific patient and then sending the syringes off to patients, which is illegal under state law.
A compounding pharmacy in Nashville, Tennessee, compounded and manufactured tens of thousands of doses of weight-loss drugs. shutdown The company shipped drugs nationwide last year, but after state regulators inspected the facility and issued a disciplinary order requiring the company to make several changes before dispensing drugs again, an executive committed suicide and the pharmacy owner opted to close.
And in Florida, a doctor reported to the state’s board of pharmacy that he had been asked by a representative of a multistate compounding pharmacy to write a prescription for a particular compounded semaglutide product, a form of prescription solicitation that is likely illegal, Carter said.
Compounding companies generally aren’t required to register with the FDA or report the drugs they dispense, meaning there’s no way to know exactly how much semaglutide or tirzepatide they’re dispensing, Davis says.
“Like whack-a-mole.”
To protect patients, the FDA imposes strict safety and quality requirements on drug manufacturers and small groups of compounding pharmacies that register as outsourcing facilities, with the idea that companies that mass-produce drugs need more scrutiny than smaller compounding pharmacies that simply customize medicines for individual patients.
Compounding pharmacies that mass-produce unapproved weight-loss drugs operate without such oversight, and because they are not required to report any cases of patient harm caused by their drugs, problems may go undetected.
“It’s like whack-a-mole,” said Al Carter, a pharmacist and executive director of the National Federation of Pharmacists’ Associations. State pharmacy boards only investigate if they receive a complaint, he said.
“There are unscrupulous operators who pose as licensed or qualified to dispense in certain states when in fact they are not,” Carter said. “My understanding is that most licensed, legitimate pharmacies do not dispense weight loss drugs.”
He said most of the complaints state regulators hear are from patients trying to buy drugs online. The American Pharmacists Association recently report The investigation found that illegal online pharmacies – many of which operate outside the United States – were selling low-quality or counterfeit weight loss drugs or making false representations about the products they sold.
However, even legitimate domestic clinics are misrepresenting the products they offer. Some clinics and online pharmacies advertise “generic” versions of semaglutide, even though the FDA has not approved any generic versions 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 which allege the companies misrepresented their compounded products as over-the-counter medications.
“Lilly will continue to pursue legal remedies against certain medical spas, wellness centers, online retailers, compounding pharmacies and others who falsely represent their products as Munjaro, Zepbound or ‘FDA-approved’ Tirzepatide,” an Eli Lilly spokesperson told Stateline in a statement.
Several states have been focusing their scrutiny on medical spas and infusion clinics that offer combination weight loss drugs. The California Board of Pharmacy recently Expanded oversight of IV hydration clinicsThey point out that even if the medicines come from a licensed compounding pharmacy, clinic staff may not be providing them to consumers legally.
And in Texas, some doctors Pushing for legislation The move will increase state oversight of medical spas following the death of a woman receiving intravenous treatment last July.
But ultimately, it is the patient’s responsibility to determine whether the medications they are taking are made by a licensed, reputable compounder.
For patients like Wysock, the compounded version of the weight-loss drug has been life-changing. Wysock says the compounded tirzepatide has helped her lose weight and keep it off, leading a healthier lifestyle and allowing her to be more devoted to her family and students.
“Being a teacher, I was on my feet all day and then I’d go home and be with my two kids and by the weekend I was exhausted,” she says. “I used to take a nap every weekend. It was a ‘non-negotiable’. Now it’s not like that anymore.”
Stateline is part of States Newsroom, a nonprofit news network supported by grants and a coalition of donors as a 501c(3) public benefit organization. Stateline maintains editorial independence. If you have questions, please contact Editor Scott S. Greenberger at 1-800-448-4490. [email protected]Follow Stateline Facebook and X.
