When Carrie Davis found out her health insurance wouldn’t cover Ozempic, she looked for another avenue to get the diabetes drug, which is increasingly being used off-label for weight loss. Ms Davis, 55, was not a diabetic but had gained 50 pounds during menopause and had developed hypothyroidism, she said, and was eager to lose weight.
After seeing someone claiming to be a doctor on TikTok saying they could help patients get a generic version of the drug, she reached out. After a few days and a brief video consultation with someone who introduced themselves as a nurse practitioner, Ms. Davis had a prescription in hand. “It was really quick,” Ms. Davis said.
It took a week for the drug to arrive – a vial filled with a purple liquid that was semaglutide, the doctor said, the same active ingredient as in Ozempic. He 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 race to find Ozempic, patients are searching telehealth platforms, medical spas and prep pharmacies for what some are touting as “generic” 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 approximately 7,500 compounding pharmacies in the United States, according to the American Pharmacists Association. Compounding involves mixing and modifying drugs, customizing them for patients with specific needs – for example, someone allergic to an ingredient in a drug may need a reformulated version.
Since the FDA’s Drug Shortage website lists Ozempic as “currently in short supply”, compounding pharmacies are permitted to purchase semaglutide from pharmaceutical ingredient manufacturers and process it into an injectable drug that they distribute. They also often mix it with B vitamins or a metabolic compound called L-carnitine, which limited research has shown may aid weight loss. Some preparation pharmacies distribute a totally different active ingredient: sodium semaglutide, the saline form of semaglutide.
In recent weeks, regulators have raised concerns about sodium semaglutide, which is sometimes sold as a research chemical. Semaglutide sodium does not appear to meet the preparation standards of federal law, in part because the substance is not part of any FDA-approved drug – and officials have expressed concern about its magnitude.
The FDA does not review compounded drugs, and has not reviewed, approved, or tested—for safety or effectiveness—pharmacy offerings of semaglutide drug preparations. The compound semaglutide poses a higher risk to patients, as would any compound drug, an agency representative said.
“There are many great compounding pharmacies that care for patients every day,” said Betty Jones, senior compliance officer for accreditation and inspection programs at the National Association of Boards of Pharmacy. “But there are some of these bad actors.”
Regulators Respond
In late April, the FDA sent a letter to the National Association of Boards of Pharmacy, saying the agency was aware that compounders might use salt forms of semaglutide. “We are not aware of any basis for preparing a drug using these semaglutide salts that would meet the requirements of federal law,” the letter read.
Functionally, when semaglutide sodium is dissolved in water, the sodium ion separates from the semaglutide molecule, leaving semaglutide and an extremely low amount of sodium, said Scott Brunner, CEO of the Alliance. for Pharmacy Compounding. But there is no data showing whether semaglutide sodium is safe for consumers, or even whether it is effective, said Mary-Haston Vest, director of the pharmacy system at UNC Health.
In response to growing questions about the compound semaglutide, the North Carolina Board of Pharmacy issued a statement prohibiting compounding pharmacies from using salt forms of semaglutide. The West Virginia Board of Pharmacy has issued its own warning on the subject. The Mississippi Board of Pharmacy also issued a similar warning, writing 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 cease and desist letters, against “entities that engage in the illegal sale of the compound semaglutide, spreading false advertisements and damaging its trademarks”.
“It’s a scary field,” said Dr. Andrew Kraftson, associate clinical professor in the division of metabolism, endocrinology and diabetes in Michigan Medicine at the University of Michigan. “And I think it’s only going to get thornier.”
Answer to a need
Prep pharmacies are trying to fill a critical void in the market, said Tenille Davis, a prep pharmacist in Arizona. “They’re not trying to make a million dollars doing this. They are trying to meet an intense and overwhelming demand from patients and providers for this product.
Some railings are in place. Under federal law, compounding pharmacies can only compound pharmaceuticals with active ingredients from FDA-registered facilities, Brunner said. And state boards of pharmacy licenses and inspect compounding pharmacies; the FDA also inspects compounding pharmacies that it believes pose a safety risk. “Just because it’s not FDA-approved doesn’t automatically mean it’s unsafe,” Brunner said.
But it’s unclear how the vitamins or other additives that pharmacies mix with semaglutide might interact, and compounding pharmacies largely make “educated guesses” about the safety of these combinations, said Professor Robin Bogner. at the University of Connecticut School of Pharmacy and a compounding specialist. “While there are no known interactions,” Dr. Vest said, “that doesn’t necessarily mean there aren’t any interactions.”
‘Too good to be true’
Ms. Davis did not appear to have a negative reaction to the medications she received, but she switched to another source to obtain compound semaglutide: a weight loss clinic that obtains its medications from a local compounding pharmacy. . The clinic required blood tests, in-person appointments and stricter monitoring than the doctor she found on TikTok had provided, she said, measures that put her more at risk. 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 – without a prescription, without supervision, just vials of the chemical, with wording on the label that semaglutide is for “research use only” . There’s a critical difference between these sites and compounding pharmacies, Brunner said. The National Association of Boards of Pharmacy maintains a list of websites that sell fraudulent and dangerous drugs, and patients should consider cross-checking to make sure they are not receiving Semaglutide through one of these channels, said Bill Cover, associate executive director of state pharmaceutical affairs. to the National Association of Boards of Pharmacy. And beware of telehealth services that offer compound semaglutide without a prescription or referral from a licensed physician, Cover added. “If it’s too good to be true, it could potentially be a big red flag,” he said.