Versions of Ozempic and Wegovy weight-loss drugs face crackdown
A growing number of states are threatening legal action against pharmacies that manufacture or distribute unauthorized versions of the weight-loss drugs Ozempic and Wegovy.
At least four states are already slow down production versions copied over safety issues and more may soon follow, experts say, as both drugs gain popularity in the US
Some compounding pharmacies in the United States are offering what appears to be semaglutide – the active ingredient in Ozempic and Wegovy – amid continued shortages.
Compounding pharmacies typically mix and modify drug ingredients to create medications tailored to specific patient needs.
They are allowed to make compound versions of commercially available drugs under special circumstances, such as a shortage, according to the Food and Drug Administration.
But state regulators who oversee pharmacies in Louisiana, Mississippi, North Carolina and West Virginia say they are aware that some compounding pharmacists use a different form of semaglutide that is not approved by the FDA, which raises safety concerns.
It’s unclear if any consumer has been harmed by the compound versions, but states are now threatening to crack down, each telling compound pharmacies in recent weeks to stop making the unapproved versions of the drug or face penalties. legal and/or regulatory consequences.
“The Board is charged with protecting the public,” the West Virginia Board of Pharmacy, which oversees pharmacies in the state, wrote in a statement posted online April 21. “Therefore, the preparation of semaglutide drug products in a manner inconsistent with applicable law may result in enforcement action.”
Joe Fontenot, executive director of the Louisiana Board of Pharmacy, told NBC News that the warnings do not mean the composition of semaglutide is prohibited.
States have contacted compounding pharmacies “to stop compounding unapproved forms of semaglutide,” he said. “Compounding pharmacies can only compound pharmaceutical products using bulk drug substances that comply with FDA guidelines.”
But semaglutide is only approved for use in its “basic form,” the FDA said in a letter to the states, which can only be acquired from Novo Nordisk, the patent holder of Ozempic and Wegovy.
This makes it nearly impossible for compounding pharmacies to manufacture the drug because Novo Nordisk does not share the drug’s ingredients with compounding pharmacists, said Susan McCoy, executive director of the Mississippi Board of Pharmacy.
Do master pharmacies offer real semaglutide?
Regulators are particularly concerned about drugs made from the sodium salt of semaglutide, a cheaper, modified version of the compound used for scientific research but not intended for use in humans, Fontenot said. Jeremy Kahn, spokesman for the FDA, said semaglutide salt is not an ingredient in any FDA-approved drug.
The compound can sometimes be found to buy online as well as at spa and weight loss clinics. It’s often cheaper and easier to access than the Ozempic and Wegovy brands, which can cost around $1,000 or more for a month’s supply.
“Salt versions of medications aren’t always a bad thing,” said Jim Yawn, owner of Uptown Pharmacy, a compounding pharmacy in Madison, Mississippi. “A lot of drugs are actually in salt form for stability issues.”
But Yawn, whose pharmacy doesn’t make the compound semaglutide, said the salty version of semaglutide — like many other substances not approved for use in the United States — isn’t regulated, monitored, or tested. by the FDA.
That means patients don’t always know what they’re getting, he added.
He noted that he had once seen a document from a manufacturer intended to verify that the substance was indeed semaglutide and met FDA approval standards.
The document looked “like something that was bought in the Alibaba marketplace and slipped through the back doors of a Chinese chemical plant,” he said.
The warning from state regulators means pharmacists compounding unauthorized versions of Ozempic and Wegovy could be fined, put on probation or lose their drug dispensing license, said Rick Niemi, CEO of Valor Compounding Pharmacy, which is based in California but ships drugs to states across the country.
“Revoking your licenses means you’re literally out of business,” said Niemi, whose pharmacy doesn’t manufacture the compound semaglutide.
He said state pharmacy regulators take the sale of unapproved drugs very seriously.
“It’s not the candy business. It’s the drug business,” he said.
So far, no compounding pharmacies have been fined or lost their license in Louisiana and Mississippi, according to state regulators.
Fontenot said Louisiana has yet to take any legal or regulatory action against the state’s compounding pharmacies. Neither did Mississippi, McCoy said.
The executive directors of the North Carolina and West Virginia Boards of Pharmacy did not immediately respond to a request for comment.
Al Carter, executive director of the National Association of Boards of Pharmacy, a nonprofit that represents state pharmacy regulators, said he was not aware of any other states taking similar action.
“However, we know that most states are investigating the composition of this product outside of federal guidelines for drugs on the FDA shortage list,” he said.
Allison Schneider, a spokeswoman for Novo Nordisk, the maker of Ozempic and Wegovy, said in a statement that the company is aware of several compounding pharmacies claiming to offer the compound semaglutide and is “taking action against these entities,” although she did not provide further information. details.
“We will not tolerate unauthorized and inappropriate use of our trademarks by others,” she said.
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