When Carrie Davis found out her health insurance wouldn’t cover Ozempic, she looked for an alternative way to get the diabetes drug being used off-label for weight loss. Ms Davies, 55, never had diabetes, but said she gained 50kg during menopause and developed hypothyroidism and was keen to lose weight.
She reached out after seeing that a doctor claiming to be a doctor on TikTok could help patients find the generic version of the drug. A few days later and after a brief video consultation with a man who introduced herself as a nurse practitioner, Ms Davies had a prescription in hand. “It was really fast,” said Mrs. Davis.
It took a week for the medicine to arrive – a vial full of liquid containing semaglutide, which the doctor said was the same active ingredient as Ozmpic. She was told to inject herself every week, as people taking Ozempic do. But her medication was shipped from a compounding pharmacy in Kentucky to her home in Galveston, Texas.
In the scramble to find Ozympic, patients are looking to telehealth platforms, medical spas and pharmacies for what some callgeneral” Versions of the drug. But Novo Nordisk, which makes Ozempic, does not sell semaglutide for reconstitution purposes, and there is no generic drug approved by the Food and Drug Administration, a Novo Nordisk representative wrote in a statement.
There are approximately 7,500 pharmacies in the United States. American Pharmacists Association. Compounding involves mixing and switching medicines, tailoring them to patients with specific needs – for example, someone allergic to an ingredient in a medicine may need a modified version.
Because the FDA’s drug shortage website lists Ozempic as “currently in short supply,” compounding pharmacies are allowed to purchase semaglutide from pharmaceutical manufacturers and compound it into the injections they give. They are also often combined with B vitamins or a metabolic compound called L-carnitine, which some research suggests may contribute to weight loss. Some compounding pharmacies are generically dispensing a different active ingredient: 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 the requirements for compounding under federal law, because the ingredient is not part of any FDA-approved drug — and officials have warned about how widespread it is.
The FDA does not screen compounded drugs, and it has not reviewed, approved, or tested—for safety or effectiveness—the semaglutide drugs that compounding pharmacies provide. Combination semaglutide poses a higher risk to patients, as any combination drug does, the agency representative said.
“There are so many compounding pharmacies out there that do great patient care every day,” said Betty Jones, senior manager of compliance for accreditation and inspection programs at the National Association of Boards of Pharmacy. But there are some of those bad actors.
Controllers respond
In late April, the FDA He sent a letter. The National Association of Boards of Pharmacy said the agency is aware that compounds may use semaglutide salt forms. “We are not aware of any basis for compounding the drug using these semaglutide salts,” the letter read.
In practice, when semaglutide sodium is dissolved in water, the sodium ion dissociates from the semaglutide molecule, leaving behind semaglutide and a much smaller amount of sodium, said Scott Brunner, CEO of the Alliance for Pharmacy Compounding. But there is no evidence that semaglutide sodium is safe or effective for consumers, said Mary-Haston Vest, director of the pharmacy system at UNC Health.
The North Carolina Board of Pharmacy issued a statement in response to questions about the compound semaglutide. Forbidden Compounding pharmacies for the use of semaglutide salt forms. Issued by the West Virginia Board of Pharmacy His own warning On the topic. The Mississippi Board of Pharmacy also resigned Same warning“Pharmaceutical manufacturers have become aware of the practice of using semaglutide salts for synthesis and may choose to take legal action to combat this practice,” he wrote.
A Novo Nordisk representative said the company is taking action “not only against illegally selling compounded semaglutide, spreading false advertising and sending cease-and-desist letters to parties who infringe its trademarks.”
“It’s a scary place,” said Dr. Andrew Craftson, a clinical associate professor in the Division of Metabolism, Endocrinology and Diabetes at the University of Michigan. “And I think it’s just going to be more of a thorn.”
meet demand
According to Tenley Davis, a compounding pharmacist in Arizona, compounding pharmacies are trying to fill a critical hole in the market. “When you do this, you’re not trying to make a million dollars. They are trying to meet high, overwhelming patient and provider demand for this product.
There are some guardrails in place. Under federal law, pharmacies can only compound drug products with active ingredients from FDA-registered facilities, Mr. Brunner said. and state pharmacies license and inspect compounding pharmacies; In addition, the FDA investigates 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,” Mr. Brunner said.
But it’s unclear how pharmacies for vitamins or other supplements interact with semaglutide, and compounding pharmacies are mostly making “educated guesses” about how safe these combinations are, said Robin Bogner, a professor at the Connecticut School of Pharmacy. Expert in integration. “Even if there are no known connections, that doesn’t mean there’s no interaction,” Dr. Vest said.
“Too good to be true.”
Ms. Davis did not appear to have had an adverse reaction to the medications she received, but she turned to another source for compounded semaglutide: a weight loss clinic that obtains the drugs from a local compounding pharmacy. The clinic requires more blood work, physical appointments and strict monitoring than a doctor she met on TikTok offers, she says, steps that make her feel more comfortable as a patient. The clinic is cheap. Both combined medications seem to work, she said.
Some websites sell what they say is semaglutide directly to consumers – no prescription, no supervision, just chemical bottles, with a label that says semaglutide is for “research use only”. There is a critical difference between those sites and compounding pharmacies, Mr. Brunner said. National Association of Boards of Pharmacy a List of websites Bill Cover, associate director of state pharmacy affairs at the National Association of Boards of Pharmacy, said they need to step up to make sure patients don’t get semaglutide through one of the channels that sell fraudulent and unsafe drugs. And beware of telehealth services that offer semaglutide without a prescription or any input from a licensed doctor, Mr. Cover added. “If it’s too good to be true, it can be a big red flag,” he said.