Regulators respond
At the end of April, the F.D.A. sent a letter to the National Association of Boards of Pharmacy, saying the agency was aware that compounders might 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 law 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 chief executive of the Alliance for Pharmacy Compounding. But there isn’t data demonstrating whether semaglutide sodium is safe for consumers, or even whether it’s effective, said Mary-Haston Vest, system director of pharmacy with UNC Health.
In response to mounting questions about compounded semaglutide, the North Carolina Board of Pharmacy issued a statement forbidding compounding pharmacies to use salt forms of semaglutide. The West Virginia Board of Pharmacy issued its own warning on the topic. The Mississippi Board of Pharmacy also released a similar warning, writing that “drug manufacturers have become aware of the practice of using semaglutide salts for compounding and may choose to initiate legal proceedings 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 are engaging in the unlawful sale of compounded semaglutide, disseminating false advertising, and infringing its trademarks.”
“It’s a scary area,” said Dr. Andrew Kraftson, a clinical associate professor in the division of metabolism, endocrinology and diabetes at Michigan Medicine at the University of Michigan. “And I think it’s only going to get more thorny.”
Meeting a need
Compounding pharmacies are attempting to fill a crucial hole in the market, said Tenille Davis, a compounding pharmacist in Arizona. “They’re not trying to make a million bucks doing this. They’re trying to meet an intense, overwhelming patient and provider demand for this product.”
There are some guardrails in place. Under federal law, compounding pharmacies can compound drug products only with active ingredients that come from facilities registered with the F.D.A., Mr. Brunner said. And state boards of pharmacy license and inspect compounding pharmacies; the F.D.A. also inspects compounding pharmacies that it believes pose a safety risk. “The fact that it’s not F.D.A.-approved doesn’t automatically mean that it’s not safe,” Mr. Brunner said.
