When Carrie Davis found out her health insurance wouldn’t cover Ozempic, she sought an alternative route to get the diabetes drug, which is increasingly being used off-label for weight loss. Mrs. Davis, 55, did not have diabetes but had gained 50 pounds during menopause and developed hypothyroidism, she said, and was eager to lose weight.
After seeing someone on TikTok claiming to be a doctor and saying he could help patients get a generic version of the medication, she reached out. After a few days and a short video consultation with someone who introduced herself as a nurse practitioner, Mrs. Davis had a prescription in her hands. “It was really fast,” Ms. Davis said.
It took a week for the drug to arrive — a vial filled with a mauve liquid that was semaglutide, the doctor said, the same active ingredient found in Ozempic. She was told to inject it weekly, just like people who take Ozempic. But her medication had been shipped to her home in Galveston, Texas, from a compounding pharmacy in Kentucky.
In the battle to find Ozempic, patients are searching telehealth platforms, medical spas and compounding pharmacies for what some call “general” versions of the drug. But Novo Nordisk, the company that makes Ozempic, does not sell semaglutide for compounding purposes, and a generic form of the drug approved by the Food and Drug Administration does not exist, a Novo Nordisk representative wrote in a statement.
There are about 7,500 compounding pharmacies in the United States, according to the American Association of Pharmacists. Compounding involves mixing and modifying drugs, tailoring them for patients with specific needs – for example, someone who is allergic to an ingredient in a drug may need a reformulated version.
Because Ozempic states on the FDA’s website that there is currently a shortage of drugs, compounding pharmacies are allowed to buy semaglutide from pharmaceutical ingredient manufacturers and compound it into an injectable drug that they provide. They also often mix it with B vitamins or a metabolic compound called L-carnitine, which limited research has shown may contribute to weight loss. Some compounding pharmacies distribute a completely different active substance: semaglutide sodium, the salt form of semaglutide.
In recent weeks, regulators have raised concerns about semaglutide sodium, which is sometimes sold as a research chemical. Semaglutide sodium does not appear to meet preparation standards in federal law, in part because the substance is not part of FDA-approved medications — and officials have expressed alarm at how widespread it is.
The FDA does not research compounded medications and has not reviewed, approved, or tested the semaglutide drugs that pharmacies offer — for safety or effectiveness. Compound semaglutide poses a higher risk to patients, as any compound drug would, an agency representative said.
“There are a lot of great compounding pharmacies out there that provide great patient care every day,” said Betty Jones, compliance senior manager of accreditation and inspection programs at the National Association of Boards of Pharmacy. “But there are some of those bad actors.”
Regulators respond
At the end of April, the FDA sent a letter to the National Association of Boards of Pharmacy, saying the agency was aware formulators may be using salt forms of semaglutide. “We are not aware of any basis for compounding a drug using these semaglutide salts that would meet federal regulatory requirements,” the letter read.
Functionally, when semaglutide sodium is dissolved in water, the sodium ion separates from the semaglutide molecule, leaving semaglutide and an extremely small amount of sodium, said Scott Brunner, the CEO of the Alliance for Pharmacy Compounding. But there’s no data showing whether semaglutide sodium is safe for consumers, or even whether it’s effective, said Mary-Haston Vest, system director of pharmacy at UNC Health.
In response to increasing questions about compounded semaglutide, the North Carolina Board of Pharmacy has issued a statement prohibit compounding pharmacies to use salt forms of semaglutide. The West Virginia Board of Pharmacy issued his own warning about the subject. The Mississippi Board of Pharmacy also has one similar warningwriting that “drug manufacturers have become aware of the practice of using semaglutide salts for compounding and may choose to take legal action to combat this practice.”
A Novo Nordisk representative said the company is taking action, including but not limited to issuing strike letters, against “entities engaged in the unlawful sale of compound semaglutide, spreading false advertising and violating its trademarks.”
“It’s a scary area,” says Dr. Andrew Kraftson, a clinical associate professor in the department of metabolism, endocrinology and diabetes at Michigan Medicine at the University of Michigan. “And I think it’s only going to get trickier.”
Satisfying a need
Compounding pharmacies are trying to fill a critical gap in the market, said Tenille Davis, an Arizona compounding pharmacist. “They’re not trying to make a million dollars off this. They are trying to meet an intense, overwhelming demand from patients and suppliers for this product.
Some guardrails have been installed. Under federal law, compounding pharmacies can only compound drugs with active ingredients that come from facilities registered with the FDA, Mr. Brunner said. And state boards of pharmacy licensing and inspect compounding pharmacies; the FDA also inspects compounding pharmacies that it believes pose a safety risk. “Just because it’s not approved by the FDA doesn’t automatically mean it’s not safe,” said Mr Brunner.
But it’s not clear how the vitamins or other additives that pharmacies mix may interact with semaglutide, and compounding pharmacies largely make “educated guesses” about how safe these combinations are, said Robin Bogner, a professor at the University of Connecticut School of Pharmacy and a compounding expert. “While there are no known interactions,” said Dr. Vest, “this doesn’t necessarily mean there are no interactions.”
‘Too good to be true’
Ms. Davis didn’t seem to have an adverse reaction to the medications she was receiving, but she did switch to another source for obtaining compound semaglutide: a weight loss clinic that gets her medications from a local compounding pharmacy. The clinic required blood work, in-person appointments, and stricter supervision than the doctor she found on TikTok had taken measures that made her feel more comfortable as a patient; the clinic also costs less. Both compound drugs seemed to work, she said.
Some websites sell what they claim to be semaglutide directly to consumers – no prescription, no supervision, just vials of the chemical, with the text on the label stating that the semaglutide is for “research use” only. There is a crucial difference between those sites and compounding pharmacies, Mr. Brunner said. The National Association of Boards of Pharmacy maintains a list of websites that sell fraudulent and unsafe drugs, and patients should consider cross-checking to make sure they’re not getting semaglutide through one of those channels, said Bill Cover, the associate executive director of state pharmacy affairs at the National Association of Boards of Pharmacy. And be wary of telehealth services that offer compound semaglutide without a prescription or any input from a licensed physician, Mr. Cover added. “If it’s too good to be true, it could be a big red flag,” he said.