When Carrie Davis found out her health insurance wouldn’t cover her ozimbek, sought an alternative route to obtaining diabetes medication, which is increasingly being used off-label for weight loss. Ms. Davis, 55, did not have diabetes, but gained 50 pounds during menopause and had 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, I reached out. After a few days and a short video consultation with someone who introduced herself as a nurse practitioner, Ms. Davis had a prescription in hand. “It was really fast,” said Ms. Davis.
It took a week for the medicine to arrive, the doctor said – a vial filled with a violet liquid of semaglutide, the same active ingredient found in Ozempic. She was told to inject weekly, just as people taking Ozempic do. But her medication was shipped to her home in Galveston, Texas, from a compound pharmacy in Kentucky.
In the quest to find Ozempic, patients are searching for telehealth platforms, medical spas, and compounding pharmacies for what some describe as “qualitative” drug versions. But Novo Nordisk, the company that makes Ozempic, does not sell semaglutide for combination purposes, and there is no generic form of the drug approved by the Food and Drug Administration, 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. Complications involve mixing and adjusting medications, and tailoring them to patients with special needs – for example, someone who is allergic to an ingredient in a medication may need a reformulated version.
Because the FDA’s drug shortage website lists Ozempic as “currently in short supply,” combination pharmacies are allowed to purchase semaglutide from pharmaceutical ingredient manufacturers and mix it into an injectable drug they distribute. 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 combination pharmacies dispense an entirely different active ingredient: semaglutide sodium, which is 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 doesn’t appear to meet federal law’s formulation criteria, in part because the substance isn’t part of any FDA-approved drug — and officials have expressed concern about its reach.
The FDA does not screen combination drugs, and has not reviewed, approved, or tested — for safety or effectiveness — semaglutide drugs that are available at pharmacies. A representative from the agency said that semaglutide poses a greater risk to patients, like any combination drug.
“There are a lot of great compounding pharmacies that provide great patient care every day,” said Betty Jones, director of compliance with accreditation and inspection programs for the National Association of Pharmacy Boards. “But there are some bad guys out there.”
The organizers are responding
At the end of April, the Food and Drug Administration I sent a message to the National Association of Pharmaceutical Boards, saying the agency was aware the two compounds may be using salt forms of semaglutide. “We are not aware of any basis for a drug formulation using semaglutide salts that meets the requirements of federal law,” the letter states.
Functionally, when sodium semaglutide is dissolved in water, the sodium ion separates from the semaglutide molecule, leaving the semaglutide and a very small amount of sodium, said Scott Brunner, CEO of the Alliance for Pharmaceutical Compounds. There is no data to say whether semaglutide sodium is safe for consumers, or even if 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 prohibition Compounding pharmacies for the use of semaglutide salt forms. Published by the West Virginia Board of Pharmacy his own warning about the topic. The Mississippi Board of Pharmacy has also released a dossier Similar warningwrites that “drug manufacturers are becoming aware of the practice of using semaglutide salts for synthesis and may choose to initiate legal action to combat this practice.”
A representative from Novo Nordisk 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 synthesized semaglutide, post false advertising, and infringe their trademarks.”
“It’s scary territory,” said Dr. Andrew Craftson, assistant professor in the department of metabolism, endocrinology, and diabetes at Michigan Medicine at the University of Michigan. “And I think it’s going to get more complicated.”
meet a need
Compounding pharmacies are trying to fill a critical gap in the market, said Tenel Davis, an Arizona-based compounding pharmacist. “They’re not trying to make millions of dollars doing this. They’re trying to meet a huge, overwhelming patient and provider demand for this product.”
There are some guardrails in place. Under federal law, compounding pharmacies can only compound drug products with active ingredients that come from facilities registered with the Food and Drug Administration, Bronner said. state boards of pharmacy licensing and inspection of compounding pharmacies; The Food and Drug Administration also screens compounding pharmacies that it believes pose a safety risk. “The fact that it has not been approved by the Food and Drug Administration does not automatically mean that it is not safe,” said Mr. Bronner.
It’s not clear how vitamin pharmacies or other additives might interact with semaglutide, said Robin Bogner, a professor at the University of Connecticut College of Pharmacy, and combination pharmacies largely make “informed guesses” about how safe these combinations are. Installation expert. “Although there are no known interactions, this does not necessarily mean that there are no interactions,” said Dr. Feist.
‘too good to be true’
Ms. Davis didn’t seem to have an adverse reaction to the medications she received, but she turned to a different source to get the compound semaglutide: a weight-loss clinic that gets her medication from a local compounding pharmacy. The clinic required blood work, in-person appointments, and tighter oversight than the doctor she found on TikTok, she said, procedures that made her feel more comfortable as a patient; The clinic also costs less. She said both combination drugs seemed to work.
Some websites sell what they claim is semaglutide directly to consumers — no prescription, no oversight, just vials of the chemical, with wording on the label that semaglutide is only for “research use.” Mr Brunner said there is a fundamental difference between those sites and combination pharmacies. The National Association of Boards of Pharmacy maintains: List of sites Fraudulent and unsafe medications are being sold to patients, said Bill Coover, associate executive director for state pharmacy affairs at the National Association of Boards of Pharmacy, and patients should consider cross-checking to ensure they are not getting semaglutide through one of these channels. And be wary of telehealth services that offer synthesized semaglutide without a prescription or any input from a licensed physician, Mr. Cover added. “If it feels too good to be true,” he said, “it’s probably a big red flag.”